european pharmacopoeia 5.8 index - 医药招商药 … · · 2007-02-102.9.17. test for...

EUROPEAN PHARMACOPOEIA 5.8

INDEXTo aid users the index includes a reference to the supplement where the latest version of a text can be found.

For example: Acetone...............................................5.1-2875

means the monograph Acetone can be found on page 2875 of Supplement 5.1.

Note that where no reference for a supplement is made, the text can be found in the principal volume.

Monographs deleted from the 5th edition are not included in the index; the list of deleted texts is found in the Contentsof this supplement, page xxxviii.

General Notices (1) apply to all monographs and other texts 5393

EUROPEAN PHARMACOPOEIA 5.8

5394 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.8 Index

Numerics1. General notices .............................................................5.6-43732.1.1. Droppers ..............................................................................172.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................17

2.1.3. Ultraviolet ray lamps for analytical purposes..............172.1.4. Sieves ...................................................................................182.1.5. Tubes for comparative tests ............................................192.1.6. Gas detector tubes.............................................................192.1. Apparatus ...............................................................................172.2.10. Viscosity - Rotating viscometer method .........5.3-33372.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation....................... 322.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 332.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 342.2.19. Amperometric titration ................................................. 342.2.1. Clarity and degree of opalescence of liquids...5.7-47772.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 352.2.22. Atomic emission spectrometry .................................... 352.2.23. Atomic absorption spectrometry ................................ 362.2.24. Absorption spectrophotometry, infrared .................. 372.2.25. Absorption spectrophotometry, ultraviolet andvisible.................................................................................5.6-4383

2.2.26. Paper chromatography ................................................. 402.2.27. Thin-layer chromatography ...............................5.2-30902.2.28. Gas chromatography ..................................................... 422.2.29. Liquid chromatography ................................................ 432.2.2. Degree of coloration of liquids...................................... 242.2.30. Size-exclusion chromatography .................................. 452.2.31. Electrophoresis ............................................................... 452.2.32. Loss on drying ................................................................ 502.2.33. Nuclear magnetic resonance spectrometry ...............512.2.34. Thermal analysis............................................................. 522.2.35. Osmolality ........................................................................ 542.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 55

2.2.37. X-ray fluorescence spectrometry................................. 562.2.38. Conductivity .........................................................5.1-27832.2.39. Molecular mass distribution in dextrans .................. 572.2.3. Potentiometric determination of pH............................ 262.2.40. Near-infrared spectrophotometry ............................... 592.2.41. Circular dichroism.......................................................... 632.2.42. Density of solids ............................................................. 642.2.43. Mass spectrometry ......................................................... 652.2.44. Total organic carbon in water for pharmaceuticaluse................................................................................................. 68

2.2.45. Supercritical fluid chromatography........................... 682.2.46. Chromatographic separation techniques.................. 692.2.47. Capillary electrophoresis ...............................................742.2.48. Raman spectrometry ..................................................... 792.2.49. Falling ball viscometer method................................... 802.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 27

2.2.54. Isoelectric focusing.........................................................812.2.55. Peptide mapping............................................................. 822.2.56. Amino acid analysis ....................................................... 862.2.5. Relative density................................................................. 272.2.6. Refractive index ................................................................ 282.2.7. Optical rotation ......................................................5.6-43832.2.8. Viscosity.............................................................................. 292.2.9. Capillary viscometer method ......................................... 292.2. Physical and physicochemical methods.......................... 232.3.1. Identification reactions of ions and functionalgroups ............................................................................... 5.5-4101

2.3.2. Identification of fatty oils by thin-layerchromatography......................................................................... 98

2.3.3. Identification of phenothiazines by thin-layerchromatography......................................................................... 99

2.3.4. Odour .................................................................................. 992.3. Identification......................................................................... 952.4.10. Lead in sugars............................................................... 1072.4.11. Phosphates..................................................................... 1082.4.12. Potassium....................................................................... 1082.4.13. Sulphates ....................................................................... 1082.4.14. Sulphated ash ......................................................5.6-43892.4.15. Nickel in polyols ........................................................... 1082.4.16. Total ash......................................................................... 1082.4.17. Aluminium...................................................................... 1082.4.18. Free formaldehyde ....................................................... 1092.4.19. Alkaline impurities in fatty oils ................................. 1092.4.1. Ammonium....................................................................... 1032.4.21. Foreign oils in fatty oils by thin-layerchromatography....................................................................... 109

2.4.22. Composition of fatty acids by gas chromato-graphy ...............................................................................5.6-4389

2.4.23. Sterols in fatty oils ..............................................5.1-27872.4.24. Identification and control of residual solvents...... 1132.4.25. Ethylene oxide and dioxan..........................................1182.4.26. N,N-Dimethylaniline .....................................................1192.4.27. Heavy metals in herbal drugs and fatty oils ............1192.4.28. 2-Ethylhexanoic acid ................................................... 1202.4.29. Composition of fatty acids in oils rich inomega-3-acids...................................................................5.5-4107

2.4.2. Arsenic .............................................................................. 1032.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ........................................................................5.2-3095

2.4.31. Nickel in hydrogenated vegetable oils ............5.7-47812.4.32. Total cholesterol in oils rich in omega-3acids...................................................................................5.8-5197

2.4.3. Calcium............................................................................. 1032.4.4. Chlorides .......................................................................... 1042.4.5. Fluorides .......................................................................... 1042.4.6. Magnesium....................................................................... 1042.4.7. Magnesium and alkaline-earth metals ....................... 1042.4.8. Heavy metals ................................................................... 1042.4.9. Iron .................................................................................... 1072.4. Limit tests ............................................................................ 1032.5.10. Oxygen-flask method................................................... 1302.5.11. Complexometric titrations.......................................... 1302.5.12. Water : semi-micro determination....................5.7-47852.5.13. Aluminium in adsorbed vaccines...............................1312.5.14. Calcium in adsorbed vaccines ....................................1312.5.15. Phenol in immunosera and vaccines ........................1312.5.16. Protein in polysaccharide vaccines ...........................1312.5.17. Nucleic acids in polysaccharide vaccines ................ 1322.5.18. Phosphorus in polysaccharide vaccines.................. 1322.5.19. O-Acetyl in polysaccharide vaccines......................... 1322.5.1. Acid value................................................................5.2-30992.5.20. Hexosamines in polysaccharide vaccines................ 1322.5.21. Methylpentoses in polysaccharide vaccines ........... 1332.5.22. Uronic acids in polysaccharide vaccines ................. 1332.5.23. Sialic acid in polysaccharide vaccines ..................... 1332.5.24. Carbon dioxide in gases.............................................. 1342.5.25. Carbon monoxide in gases ......................................... 1342.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 135

2.5.27. Oxygen in gases ............................................................ 1362.5.28. Water in gases............................................................... 1362.5.29. Sulphur dioxide ............................................................ 1362.5.2. Ester value ....................................................................... 1272.5.30. Oxidising substances................................................... 1372.5.31. Ribose in polysaccharide vaccines............................ 1372.5.32. Water: micro determination ...................................... 137


Index EUROPEAN PHARMACOPOEIA 5.8

2.5.33. Total protein.................................................................. 1382.5.34. Acetic acid in synthetic peptides ...............................1412.5.35. Nitrous oxide in gases ..................................................1412.5.36. Anisidine value ............................................................. 1422.5.3. Hydroxyl value ................................................................ 1272.5.4. Iodine value ..................................................................... 1272.5.5. Peroxide value................................................................. 1282.5.6. Saponification value ...................................................... 1292.5.7. Unsaponifiable matter ................................................... 1292.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 129

2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 129

2.5. Assays ................................................................................... 1272.6.10. Histamine ....................................................................... 1532.6.11. Depressor substances.................................................. 1532.6.12. Microbiological examination of non-sterile products :total viable aerobic count .............................................5.6-4398

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ..............................5.6-4404

2.6.14. Bacterial endotoxins .....................................................1612.6.15. Prekallikrein activator........................................5.5-41112.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 169

2.6.17. Test for anticomplementary activity ofimmunoglobulin....................................................................... 170

2.6.18. Test for neurovirulence of live virus vaccines........ 1722.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 172

2.6.1. Sterility ............................................................................. 1452.6.20. Anti-A and anti-B haemagglutinins(indirect method) ......................................................................174

2.6.21. Nucleic acid amplification techniques ............ 5.5-41112.6.22. Activated coagulation factors ...........................5.5-41152.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ............................................................................5.4-3699

2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .....................................5.3-3345

2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ....................................5.3-3348

2.6.27. Microbiological control of cellular products ..5.6-44142.6.2. Mycobacteria ................................................................... 1492.6.7. Mycoplasmas...........................................................5.8-52012.6.8. Pyrogens........................................................................... 1522.6.9. Abnormal toxicity ........................................................... 1532.6. Biological tests ................................................................... 1452.7.10. Assay of human coagulation factor VII ..........5.6-44192.7.11. Assay of human coagulation factor IX ............5.5-41202.7.12. Assay of heparin in coagulation factors .................. 2042.7.13. Assay of human anti-D immunoglobulin................. 2052.7.14. Assay of hepatitis A vaccine ..............................5.1-27952.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2072.7.16. Assay of pertussis vaccine (acellular)....................... 2082.7.17. Assay of human antithrombin III .............................. 2092.7.18. Assay of human coagulation factor II ...................... 2092.7.19. Assay of human coagulation factor X .......................2102.7.1. Immunochemical methods ........................................... 1872.7.20. In vivo assay of poliomyelitis vaccine(inactivated) .....................................................................5.6-4420

2.7.21. Assay of human von Willebrand factor...........5.5-41202.7.22. Assay of human coagulation factor XI............5.5-41212.7.23. Numeration of CD34/CD45+ cells in haematopoieticproducts ............................................................................5.6-4421

2.7.24. Flow cytometry ....................................................5.6-44232.7.27. Flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (Ramon assay)...............................5.6-4424

2.7.2. Microbiological assay of antibiotics ............................ 1882.7.4. Assay of human coagulation factor VIII ...........5.5-41192.7.5. Assay of heparin.....................................................5.6-4419

2.7.6. Assay of diphtheria vaccine (adsorbed) ............5.7-47892.7.7. Assay of pertussis vaccine............................................. 1972.7.8. Assay of tetanus vaccine (adsorbed)..................5.7-47932.7.9. Test for Fc function of immunoglobulin ................... 2022.7. Biological assays ................................................................ 1872.8.10. Solubility in alcohol of essential oils ........................2162.8.11. Assay of 1,8-cineole in essential oils .........................2162.8.12. Determination of essential oils in vegetabledrugs............................................................................................217

2.8.13. Pesticide residues..........................................................2182.8.14. Determination of tannins in herbal drugs .............. 2212.8.15. Bitterness value ............................................................ 2212.8.16. Dry residue of extracts................................................ 2222.8.17. Loss on drying of extracts .......................................... 2222.8.18. Determination of aflatoxin B1 in herbaldrugs..................................................................................5.7-4801

2.8.1. Ash insoluble in hydrochloric acid ............................. 2152.8.2. Foreign matter ................................................................ 2152.8.3. Stomata and stomatal index ........................................ 2152.8.4. Swelling index ................................................................. 2152.8.5. Water in essential oils.....................................................2162.8.6. Foreign esters in essential oils .....................................2162.8.7. Fatty oils and resinified essential oils in essentialoils................................................................................................216

2.8.8. Odour and taste of essential oils..................................2162.8.9. Residue on evaporation of essential oils ....................2162.8. Methods in pharmacognosy ............................................ 2152.9.10. Ethanol content and alcoholimetric tables ............ 2372.9.11. Test for methanol and 2-propanol ...................5.3-33622.9.12. Sieve test ........................................................................ 2392.9.14. Specific surface area by air permeability ................ 2392.9.15. Apparent volume .......................................................... 2412.9.16. Flowability...................................................................... 2422.9.17. Test for extractable volume of parenteralpreparations .....................................................................5.3-3363

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ...............................................................5.2-3103

2.9.19. Particulate contamination : sub-visible particles... 2532.9.1. Disintegration of tablets and capsules..............5.3-33512.9.20. Particulate contamination : visible particles .......... 2552.9.22. Softening time determination of lipophilicsuppositories............................................................................. 256

2.9.23. Pycnometric density of solids.................................... 2572.9.24. Resistance to rupture of suppositories andpessaries .................................................................................... 258

2.9.25. Dissolution test for medicated chewinggums .................................................................................. 5.2-3116

2.9.26. Specific surface area by gas adsorption.........5.1-28112.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 263

2.9.28. Test for deliverable mass or volume of liquid andsemi-solid preparations........................................................... 263

2.9.29. Intrinsic dissolution............................................5.4-37052.9.2. Disintegration of suppositories and pessaries ......... 2272.9.31. Particle size analysis by laser lightdiffraction .........................................................................5.6-4429

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)................5.6-4432

2.9.36. Powder flow..........................................................5.3-33632.9.37. Optical microscopy..............................................5.3-33662.9.38. Particle-size distribution estimation by analyticalsieving ...............................................................................5.3-3368

2.9.3. Dissolution test for solid dosage forms ............5.7-48052.9.40. Uniformity of dosage units................................5.3-33702.9.42. Dissolution test for lipophilic solid dosageforms..................................................................................5.3-3373

2.9.43. Apparent dissolution ..........................................5.6-44382.9.4. Dissolution test for transdermal patches .................. 2312.9.5. Uniformity of mass of single-dose preparations....... 233



2.9.6. Uniformity of content of single-dose preparations.. 2342.9.7. Friability of uncoated tablets ..............................5.2-31032.9.8. Resistance to crushing of tablets................................ 2352.9.9. Measurement of consistency by penetrometry ........ 2352.9. Pharmaceutical technical procedures ........................... 2253.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 289

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .......................................................................... 291

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 269

3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 272

3.1.13. Plastic additives ............................................................ 2933.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 296

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 298

3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 269

3.1.3. Polyolefines...................................................................... 2743.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 278

3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 279

3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 282

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 285

3.1.8. Silicone oil used as a lubricant ................................... 2873.1.9. Silicone elastomer for closures and tubing .............. 2883.1. Materials used for the manufacture of containers ..... 2693.2.1. Glass containers for pharmaceutical use .................. 3033.2.2.1. Plastic containers for aqueous solutions forparenteral infusion .................................................................. 309

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 308

3.2.3. Sterile plastic containers for human blood and bloodcomponents............................................................................... 309

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components...........311

3.2.5. Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution....... 312

3.2.6. Sets for the transfusion of blood and bloodcomponents................................................................................313

3.2.8. Sterile single-use plastic syringes ................................3143.2.9. Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders ..316

3.2. Containers ..................................................................5.6-44434.1.1. Reagents ..................................................................5.7-48174.1.1. Reagents ..................................................................5.8-52094.1.2. Standard solutions for limit tests.......................5.7-49284.1.2. Standard solutions for limit tests.......................5.8-52094.1.3. Buffer solutions .....................................................5.7-49324.1. Reagents, standard solutions, buffer solutions ..5.7-48174.2.1. Primary standards for volumetric solutions....5.7-49374.2.2. Volumetric solutions.............................................5.7-49384.2. Volumetric analysis...................................................5.7-49374. Reagents.........................................................................5.7-48175.10. Control of impurities in substances for pharmaceuticaluse......................................................................................5.5-4145

5.11. Characters section in monographs .............................. 5655.1.1. Methods of preparation of sterile products .............. 4455.1.2. Biological indicators of sterilisation........................... 447

5.12. Reference standards...............................................5.6-44555.1.3. Efficacy of antimicrobial preservation ....................... 4475.14. Gene transfer medicinal products for humanuse......................................................................................5.6-4461

5.1.4. Microbiological quality of pharmaceuticalpreparations .....................................................................5.6-4451

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ....................................................5.1-2821

5.1.6. Alternative methods for control of microbiologicalquality................................................................................5.5-4131

5.1.7. Viral safety...............................................................5.8-52135.1. General texts on sterility .................................................. 4455.2.1. Terminology used in monographs on vaccines ....... 4535.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines...............5.1-2825

5.2.3. Cell substrates for the production of vaccines forhuman use................................................................................. 455

5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 458

5.2.5. Substances of animal origin for the production ofveterinary vaccines.................................................................. 460

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ....................................................................5.1-2827

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .....................................................................5.1-2829

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 463

5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera.............................................5.1-2830

5.2. General texts on vaccines................................................. 4535.3. Statistical analysis of results of biological assays andtests............................................................................................. 475

5.4. Residual solvents ............................................................... 5075.5. Alcoholimetric tables .........................................................5195.6. Assay of interferons..................................................5.3-33815.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 539

5.8. Pharmacopoeial harmonisation ..................................... 5515.9. Polymorphism..................................................................... 555

AAbbreviations and symbols (1.) ......................................5.6-4373Abnormal toxicity (2.6.9.)......................................................... 153Absinthii herba .................................................................5.8-5391Absorption spectrophotometry, infrared (2.2.24.) ................ 37Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .............................................................................5.6-4383

Acacia............................................................................................ 905Acaciae gummi .......................................................................... 905Acaciae gummi dispersione desiccatum............................. 905Acacia, spray-dried ..................................................................... 905Acamprosate calcium ................................................................ 906Acamprosatum calcicum......................................................... 906Acarbose..............................................................................5.1-2873Acarbosum .........................................................................5.1-2873Acebutolol hydrochloride................................................5.4-3889Acebutololi hydrochloridum .........................................5.4-3889Aceclofenac.................................................................................. 909Aceclofenacum ........................................................................... 909Acesulfame potassium .....................................................5.4-3890Acesulfamum kalicum ....................................................5.4-3890Acetazolamide............................................................................. 912Acetazolamidum........................................................................ 912Acetic acid, glacial ......................................................................913Acetic acid in synthetic peptides (2.5.34.) .............................141Acetone................................................................................5.1-2875Acetonum ...........................................................................5.1-2875Acetylcholine chloride ...............................................................914



Acetylcholini chloridum ...........................................................914Acetylcysteine ..............................................................................915Acetylcysteinum .........................................................................915β-Acetyldigoxin ..................................................................5.6-4499β-Acetyldigoxinum ...........................................................5.6-4499Acetylsalicylic acid ......................................................................917Acetyltryptophan, N- ..................................................................918Acetyltyrosine, N- ....................................................................... 920Aciclovir ..............................................................................5.3-3436Aciclovirum .......................................................................5.3-3436Acidum 4-aminobenzoicum ................................................... 973Acidum aceticum glaciale........................................................913Acidum acetylsalicylicum ........................................................917Acidum adipicum ...................................................................... 926Acidum alginicum..................................................................... 942Acidum amidotrizoicum dihydricum .................................. 967Acidum aminocaproicum ....................................................... 974Acidum ascorbicum .........................................................5.6-4511Acidum asparticum ................................................................ 1029Acidum benzoicum ................................................................. 1072Acidum boricum .......................................................................1117Acidum caprylicum ................................................................ 1172Acidum chenodeoxycholicum..............................................1247Acidum citricum anhydricum .............................................1306Acidum citricum monohydricum .......................................1307Acidum edeticum .............................................................5.4-3933Acidum etacrynicum ..............................................................1542Acidum folicum ................................................................5.6-4582Acidum fusidicum ................................................................... 1645Acidum glutamicum ............................................................... 1670Acidum hydrochloridum concentratum............................ 1755Acidum hydrochloridum dilutum ....................................... 1756Acidum iopanoicum ...............................................................1824Acidum iotalamicum ..............................................................1825Acidum ioxaglicum.................................................................1826Acidum lacticum ..............................................................5.2-3227Acidum lactobionicum...........................................................1885Acidum maleicum ...................................................................1966Acidum malicum .....................................................................1966Acidum mefenamicum...........................................................1984Acidum methacrylicum et ethylis acrylas polymerisatum1:1 ......................................................................................5.7-5050

Acidum methacrylicum et ethylis acrylas polymerisatum1:1 dispersio 30 per centum ..............................................2005

Acidum methacrylicum et methylis methacrylaspolymerisatum 1:1................................................................2006

Acidum methacrylicum et methylis methacrylaspolymerisatum 1:2................................................................2007

Acidum nalidixicum ...............................................................2080Acidum nicotinicum...............................................................2097Acidum nitricum ..................................................................... 2105Acidum oleicum....................................................................... 2132Acidum oxolinicum ................................................................ 2165Acidum palmiticum ................................................................ 2179Acidum phosphoricum concentratum ...............................2237Acidum phosphoricum dilutum ..........................................2238Acidum pipemidicum trihydricum .....................................2249Acidum salicylicum .........................................................5.1-3007Acidum (S)-lacticum ........................................................5.2-3227Acidum sorbicum ....................................................................2467Acidum stearicum ............................................................5.6-4681Acidum sulfuricum .................................................................2520Acidum tartaricum .................................................................2534Acidum thiocticum...........................................................5.5-4312Acidum tiaprofenicum ...........................................................2578Acidum tolfenamicum............................................................ 2601Acidum tranexamicum ...................................................5.8-5382Acidum trichloraceticum ......................................................2620Acidum undecylenicum ........................................................2658

Acidum ursodeoxycholicum..........................................5.7-5133Acidum valproicum ................................................................2669Acid value (2.5.1.)..............................................................5.2-3099Acitretin........................................................................................ 922Acitretinum ................................................................................. 922Acriflavinii monochloridum .................................................. 924Acriflavinium monochloride.................................................... 924Actinobacillosis vaccine (inactivated), porcine .................... 784Activated charcoal....................................................................1246Activated coagulation factors (2.6.22.).........................5.5-4115Additives, plastic (3.1.13.)......................................................... 293Adenine ........................................................................................ 924Adeninum.................................................................................... 924Adenosine .................................................................................... 925Adenosinum ............................................................................... 925Adenovirus vectors for human use ...............................5.6-4462Adeps lanae .......................................................................5.8-5387Adeps lanae cum aqua...........................................................2709Adeps lanae hydrogenatus ...................................................2708Adeps solidus............................................................................ 1711Adipic acid ................................................................................... 926Adrenaline tartrate ...........................................................5.8-5269Adrenalini tartras.............................................................5.8-5269Aer medicinalis.......................................................................... 929Aer medicinalis artificiosus ................................................... 932Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) .........................................................5.2-3103

Aether .........................................................................................1548Aether anaestheticus ..............................................................1549Aetherolea ..........................................................................5.8-5218Aflatoxin B1 in herbal drugs, determination of(2.8.18.) .............................................................................5.7-4801

Agar............................................................................................... 928Agni casti fructus .............................................................5.6-4500Agnus castus fruit.............................................................5.6-4500Agrimoniae herba ..................................................................... 929Agrimony ..................................................................................... 929Air, medicinal .............................................................................. 929Air, synthetic medicinal ............................................................ 932Alanine ......................................................................................... 933Alaninum..................................................................................... 933Albendazole................................................................................. 934Albendazolum ............................................................................ 934Albumini humani solutio ...............................................5.3-3511Albumin solution, human................................................5.3-3511Alchemilla .................................................................................... 935Alchemillae herba ..................................................................... 935Alcohol benzylicus ...........................................................5.6-4521Alcohol cetylicus...............................................................5.3-3475Alcohol cetylicus et stearylicus ....................................5.3-3474Alcohol cetylicus et stearylicus emulsificans A .......5.6-4545Alcohol cetylicus et stearylicus emulsificans B .......5.6-4546Alcoholes adipis lanae ...........................................................2703Alcoholimetric tables (2.9.10.) ................................................ 237Alcoholimetric tables (5.5.) .......................................................519Alcohol isopropylicus............................................................. 1841Alcohol oleicus ......................................................................... 2134Alcohol stearylicus...........................................................5.3-3621Alcuronii chloridum ................................................................. 935Alcuronium chloride.................................................................. 935Alexandrian senna pods .........................................................2404Alfacalcidol .................................................................................. 937Alfacalcidolum ........................................................................... 937Alfadex.......................................................................................... 938Alfadexum ................................................................................... 938Alfentanil hydrochloride........................................................... 939Alfentanili hydrochloridum.................................................... 939Alfuzosin hydrochloride ........................................................... 941Alfuzosini hydrochloridum .................................................... 941



Alginic acid .................................................................................. 942Alkaline-earth metals and magnesium (2.4.7.) .................... 104Alkaline impurities in fatty oils (2.4.19.) ............................... 109Allantoin....................................................................................... 942Allantoinum................................................................................ 942Allergen products..............................................................5.8-5217Allii sativi bulbi pulvis ........................................................... 1651Allium sativum ad praeparationes homoeopathicas ....... 897Allopurinol................................................................................... 943Allopurinolum............................................................................ 943all-rac-α-Tocopherol..........................................................5.6-4688all-rac-α-Tocopheryl acetate ...........................................5.6-4691Almagate .............................................................................5.2-3169Almagatum.........................................................................5.2-3169Almond oil, refined ...........................................................5.4-3893Almond oil, virgin .............................................................5.3-3437Aloe barbadensis ....................................................................... 947Aloe capensis.............................................................................. 948Aloes, barbados .......................................................................... 947Aloes, Cape .................................................................................. 948Aloes dry extract, standardised............................................... 949Aloes extractum siccum normatum...................................... 949Alphacyclodextrin ...................................................................... 938Alprazolam .................................................................................. 950Alprazolamum ........................................................................... 950Alprenolol hydrochloride ......................................................... 952Alprenololi hydrochloridum................................................... 952Alprostadil ................................................................................... 953Alprostadilum............................................................................. 953Alteplase for injection ............................................................... 956Alteplasum ad iniectabile........................................................ 956Alternative methods for control of microbiological quality(5.1.6.)................................................................................5.5-4131

Althaeae folium........................................................................ 1974Althaeae radix ...................................................................5.2-3232Alum.............................................................................................. 959Alumen......................................................................................... 959Aluminii chloridum hexahydricum ..................................... 960Aluminii hydroxidum hydricum ad adsorptionem ..5.5-4186Aluminii magnesii silicas ....................................................... 961Aluminii oxidum hydricum .................................................... 962Aluminii phosphas hydricus .................................................. 963Aluminii phosphatis liquamen .....................................5.3-3438Aluminii sulfas........................................................................... 964Aluminium (2.4.17.) ................................................................... 108Aluminium chloride hexahydrate ........................................... 960Aluminium hydroxide, hydrated, for adsorption........5.5-4186Aluminium in adsorbed vaccines (2.5.13.).............................131Aluminium magnesium silicate............................................... 961Aluminium oxide, hydrated...................................................... 962Aluminium phosphate gel ...............................................5.3-3438Aluminium phosphate, hydrated ............................................ 963Aluminium sulphate .................................................................. 964Alverine citrate ..................................................................5.6-4502Alverini citras ....................................................................5.6-4502Amantadine hydrochloride ...................................................... 964Amantadini hydrochloridum ................................................. 964Ambroxol hydrochloride........................................................... 965Ambroxoli hydrochloridum .................................................... 965Amfetamine sulphate ................................................................ 966Amfetamini sulfas ..................................................................... 966Amidotrizoic acid dihydrate..................................................... 967Amikacin ...................................................................................... 968Amikacini sulfas ...............................................................5.4-3894Amikacin sulphate ............................................................5.4-3894Amikacinum ............................................................................... 968Amiloride hydrochloride..................................................5.3-3439Amiloridi hydrochloridum.............................................5.3-3439Amino acid analysis (2.2.56.) ..................................................... 86

Aminobenzoic acid, 4- ............................................................... 973Aminocaproic acid ..................................................................... 974Aminoglutethimide.................................................................... 975Aminoglutethimidum ............................................................... 975Amiodarone hydrochloride .............................................5.7-4965Amiodaroni hydrochloridum ........................................5.7-4965Amisulpride ........................................................................5.6-4503Amisulpridum ...................................................................5.6-4503Amitriptyline hydrochloride .................................................... 980Amitriptylini hydrochloridum ............................................... 980Amlodipine besilate ................................................................... 981Amlodipini besilas .................................................................... 981Ammonia (13N) injection ............................................................817Ammoniae (13N) solutio iniectabilis ......................................817Ammoniae solutio concentrata ............................................. 983Ammonia solution, concentrated ........................................... 983Ammonii bromidum ................................................................. 985Ammonii chloridum ................................................................. 986Ammonii glycyrrhizas ....................................................5.1-2876Ammonii hydrogenocarbonas ............................................... 988Ammonio methacrylate copolymer (type A) ...............5.6-4504Ammonio methacrylate copolymer (type B) ...............5.6-4505Ammonio methacrylatis copolymerum A..................5.6-4504Ammonio methacrylatis copolymerum B .................5.6-4505Ammonium (2.4.1.) .................................................................... 103Ammonium bromide.................................................................. 985Ammonium chloride.................................................................. 986Ammonium glycyrrhizate................................................5.1-2876Ammonium hydrogen carbonate ............................................ 988Amobarbital................................................................................. 988Amobarbital sodium .................................................................. 989Amobarbitalum .......................................................................... 988Amobarbitalum natricum ....................................................... 989Amoxicillin sodium .................................................................... 990Amoxicillin trihydrate ......................................................5.3-3440Amoxicillinum natricum ......................................................... 990Amoxicillinum trihydricum...........................................5.3-3440Amperometric titration (2.2.19.) ............................................... 34Amphotericin B .......................................................................... 995Amphotericinum B ................................................................... 995Ampicillin, anhydrous .............................................................. 996Ampicillin sodium ...................................................................... 998Ampicillin trihydrate ........................................................5.8-5270Ampicillinum anhydricum ..................................................... 996Ampicillinum natricum ........................................................... 998Ampicillinum trihydricum.............................................5.8-5270Amygdalae oleum raffinatum .......................................5.4-3893Amygdalae oleum virginale ..........................................5.3-3437Amylum pregelificatum .........................................................2490Anaesthetic ether .....................................................................1549Analysis, thermal (2.2.34.).......................................................... 52Analytical sieving, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368

Angelicae radix ........................................................................ 1003Angelica root ............................................................................. 1003Anhydrous silica, hydrophobic colloidal ......................5.8-5362Animal anti-T lymphocyte immunoglobulin for humanuse......................................................................................5.6-4506

Animal immunosera for human use..............................5.8-5222Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 577

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463

Aniseed ....................................................................................... 1006Anise oil...................................................................................... 1004Anisi aetheroleum ................................................................... 1004Anisidine value (2.5.36.) ........................................................... 142Anisi fructus ............................................................................. 1006



Anisi stellati aetheroleum .....................................................2488Anisi stellati fructus.........................................................5.5-4297Antazoline hydrochloride....................................................... 1006Antazolini hydrochloridum.................................................. 1006Anthrax spore vaccine (live) for veterinary use................... 715Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ..............................................................5.6-4479

Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) .......................................................................................174

Antibiotics, microbiological assay of (2.7.2.) ........................ 188Antibodies for human use, monoclonal .......................5.8-5224Anticoagulant and preservative solutions for human blood................................................................................................... 1007

Anticomplementary activity of immunoglobulin (2.6.17.).. 170Anticorpora monoclonalia ad usum humanum ......5.8-5224Anti-D antibodies in human immunoglobulins for intravenousadministration, test for (2.6.26.) ..................................5.3-3348

Anti-D immunoglobulin, human ....................................5.6-4595Anti-D immunoglobulin, human, assay of (2.7.13.)............. 205Anti-D immunoglobulin, human, for intravenousadministration .................................................................5.6-4595

Antimicrobial preservation, efficacy of (5.1.3.) .................... 447Antiserum, European viper venom ........................................ 806Antithrombin III concentrate, human ................................. 1733Antithrombin III, human, assay of (2.7.17.) .......................... 209Antithrombinum III humanum densatum ....................... 1733Anti-T lymphocyte immunoglobulin for human use,animal................................................................................5.6-4506

Apis mellifera ad praeparationes homoeopathicas.......... 898Apomorphine hydrochloride ..................................................1014Apomorphini hydrochloridum .............................................1014Apparatus (2.1.) .............................................................................17Apparent dissolution (2.9.43.) ........................................5.6-4438Apparent volume (2.9.15.)........................................................ 241Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.).......................................5.1-2821

Aprotinin .................................................................................... 1015Aprotinin concentrated solution........................................... 1016Aprotinini solutio concentrata ............................................ 1016Aprotininum ............................................................................. 1015Aqua ad dilutionem solutionium concentratarum adhaemodialysim ...................................................................... 1699

Aqua ad iniectabilia ...............................................................2692Aquae (15O) solutio iniectabilis .............................................. 868Aquae tritiatae (3H) solutio iniectabilis ............................... 867Aqua purificata ........................................................................2697Aqua valde purificata.............................................................2695Arachidis oleum hydrogenatum.......................................... 1018Arachidis oleum raffinatum ..........................................5.5-4187Arachis oil, hydrogenated ...................................................... 1018Arachis oil, refined............................................................5.5-4187Argenti nitras ........................................................................... 2412Argentum colloidale ad usum externum ...................5.3-3613Arginine...................................................................................... 1019Arginine aspartate ................................................................... 1020Arginine hydrochloride........................................................... 1021Arginini aspartas .................................................................... 1020Arginini hydrochloridum...................................................... 1021Argininum................................................................................. 1019Arnicae flos............................................................................... 1022Arnicae tinctura ...............................................................5.1-2877Arnica flower............................................................................. 1022Arnica tincture...................................................................5.1-2877Arsenic (2.4.2.) ............................................................................ 103Arsenii trioxidum ad praeparationes homoeopathicas .. 895Arsenious trioxide for homoeopathic preparations............ 895Articaine hydrochloride.......................................................... 1023Articaini hydrochloridum ..................................................... 1023Artichoke leaf.....................................................................5.7-4966

Ascorbic acid ......................................................................5.6-4511Ascorbylis palmitas..........................................................5.6-4512Ascorbyl palmitate ............................................................5.6-4512Ash insoluble in hydrochloric acid (2.8.1.) ........................... 215Ash leaf....................................................................................... 1026Asparagine monohydrate .......................................................1027Asparaginum monohydricum.............................................. 1027Aspartame.................................................................................. 1028Aspartamum ............................................................................. 1028Aspartic acid.............................................................................. 1029Assay of 1,8-cineole in essential oils (2.8.11.) .......................216Assay of diphtheria vaccine (adsorbed) (2.7.6.) ..........5.7-4789Assay of heparin (2.7.5.) ..................................................5.6-4419Assay of heparin in coagulation factors (2.7.12.) ................ 204Assay of hepatitis A vaccine (2.7.14.) ............................5.1-2795Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 207Assay of human anti-D immunoglobulin (2.7.13.)............... 205Assay of human antithrombin III (2.7.17.) ............................ 209Assay of human coagulation factor II (2.7.18.).................... 209Assay of human coagulation factor IX (2.7.11.)..........5.5-4120Assay of human coagulation factor VII (2.7.10.) ........5.6-4419Assay of human coagulation factor VIII (2.7.4.).........5.5-4119Assay of human coagulation factor X (2.7.19.) .....................210Assay of human coagulation factor XI (2.7.22.) .........5.5-4121Assay of human von Willebrand factor (2.7.21.) ........5.5-4120Assay of interferons (5.6.)................................................5.3-3381Assay of pertussis vaccine (2.7.7.)........................................... 197Assay of pertussis vaccine (acellular) (2.7.16.) .................... 208Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) .............................................................................5.6-4420

Assay of tetanus vaccine (adsorbed) (2.7.8.) ...............5.7-4793Assays (2.5.) ................................................................................. 127Astemizole ................................................................................. 1030Astemizolum ............................................................................. 1030Atenolol ......................................................................................1032Atenololum................................................................................ 1032Atomic absorption spectrometry (2.2.23.) .............................. 36Atomic emission spectrometry (2.2.22.).................................. 35Atracurii besilas................................................................5.2-3170Atracurium besilate ..........................................................5.2-3170Atropine ..................................................................................... 1033Atropine sulphate..................................................................... 1035Atropini sulfas.......................................................................... 1035Atropinum ................................................................................. 1033Aujeszky’s disease vaccine (inactivated) for pigs................ 715Aujeszky’s disease vaccine (live) for pigs for parenteraladministration, freeze-dried....................................................717

Aurantii amari epicarpii et mesocarpii tinctura ............ 1110Aurantii amari epicarpium et mesocarpium................... 1110Aurantii amari flos ..................................................................1111Aurantii dulcis aetheroleum.................................................2526Auricularia.........................................................................5.5-4156Avian infectious bronchitis vaccine (inactivated).......5.4-3881Avian infectious bronchitis vaccine (live) ............................. 720Avian infectious bursal disease vaccine (inactivated) ....... 722Avian infectious bursal disease vaccine (live) ...................... 723Avian infectious encephalomyelitis vaccine (live) ............... 725Avian infectious laryngotracheitis vaccine (live)................. 727Avian live virus vaccines : tests for extraneous agents inbatches of finished product (2.6.25.)..........................5.3-3345

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .....................................................................5.6-4492

Avian paramyxovirus 3 vaccine (inactivated)....................... 728Avian tuberculin purified protein derivative...............5.7-5129Avian viral tenosynovitis vaccine (live).................................. 729Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .............................................................................5.4-3699

Azaperone for veterinary use ................................................ 1036Azaperonum ad usum veterinarium..................................1036



Azathioprine.............................................................................. 1037Azathioprinum......................................................................... 1037Azelastine hydrochloride........................................................ 1037Azelastini hydrochloridum ................................................... 1037Azithromycin......................................................................5.6-4513Azithromycinum...............................................................5.6-4513

BBacampicillin hydrochloride.................................................. 1043Bacampicillini hydrochloridum.......................................... 1043Bacitracin................................................................................... 1045Bacitracinum............................................................................ 1045Bacitracinum zincum ............................................................ 1047Bacitracin zinc .......................................................................... 1047Baclofen ..................................................................................... 1050Baclofenum............................................................................... 1050Bacterial cells used for the manufacture of plasmid vectorsfor human use .................................................................5.6-4468

Bacterial endotoxins (2.6.14.)...................................................161Ballotae nigrae herba ............................................................ 1113Balsamum peruvianum......................................................... 2215Balsamum tolutanum ............................................................2603Bambuterol hydrochloride..................................................... 1051Bambuteroli hydrochloridum .............................................. 1051Barbados aloes ........................................................................... 947Barbital....................................................................................... 1052Barbitalum ................................................................................ 1052Barii chloridum dihydricum ad praeparationeshomoeopathicas .............................................................5.2-3161

Barii sulfas .........................................................................5.4-3901Barium chloride dihydrate for homoeopathicpreparations .....................................................................5.2-3161

Barium sulphate................................................................5.4-3901Basic butylated methacrylate copolymer............................ 1053BCG ad immunocurationem .................................................. 635BCG for immunotherapy .......................................................... 635BCG vaccine, freeze-dried ........................................................ 636Bearberry leaf ...........................................................................1054Beclometasone dipropionate, anhydrous ....................5.5-4193Beclometasone dipropionate monohydrate ................5.5-4195Beclometasoni dipropionas anhydricus ....................5.5-4193Beclometasoni dipropionas monohydricus ..............5.5-4195Bee for homoeopathic preparations, honey......................... 898Beeswax, white ..................................................................5.4-3901Beeswax, yellow.................................................................5.4-3902Belladonnae folii extractum siccum normatum ............. 1060Belladonnae folii tinctura normata ................................... 1061Belladonnae folium ................................................................ 1058Belladonnae pulvis normatus.............................................. 1062Belladonna leaf......................................................................... 1058Belladonna leaf dry extract, standardised .......................... 1060Belladonna leaf tincture, standardised................................ 1061Belladonna, prepared .............................................................. 1062Bendroflumethiazide .......................................................5.6-4519Bendroflumethiazidum ..................................................5.6-4519Benfluorex hydrochloride ...................................................... 1064Benfluorexi hydrochloridum ............................................... 1064Benperidol ................................................................................. 1065Benperidolum .......................................................................... 1065Benserazide hydrochloride .................................................... 1067Benserazidi hydrochloridum ............................................... 1067Bentonite ................................................................................... 1068Bentonitum ............................................................................... 1068Benzalkonii chloridi solutio ................................................ 1069Benzalkonii chloridum.......................................................... 1068Benzalkonium chloride........................................................... 1068Benzalkonium chloride solution .......................................... 1069Benzathine benzylpenicillin ..................................................1077Benzbromarone........................................................................ 1070

Benzbromaronum ................................................................... 1070Benzethonii chloridum ......................................................... 1071Benzethonium chloride .......................................................... 1071Benzocaine ................................................................................ 1072Benzocainum ........................................................................... 1072Benzoe sumatranus .........................................................5.6-4519Benzoe tonkinensis .........................................................5.2-3175Benzoic acid .............................................................................. 1072Benzoin, Siam....................................................................5.2-3175Benzoin, Sumatra .............................................................5.6-4519Benzoin tincture, Siam ....................................................5.4-3902Benzoin tincture, Sumatra..............................................5.6-4520Benzois sumatrani tinctura...........................................5.6-4520Benzois tonkinensis tinctura ........................................5.4-3902Benzoylis peroxidum cum aqua ......................................... 1073Benzoyl peroxide, hydrous .................................................... 1073Benzyl alcohol ...................................................................5.6-4521Benzyl benzoate ....................................................................... 1076Benzylis benzoas..................................................................... 1076Benzylpenicillin, benzathine ................................................. 1077Benzylpenicillin potassium.............................................5.2-3175Benzylpenicillin, procaine...................................................... 1080Benzylpenicillin sodium ..................................................5.2-3177Benzylpenicillinum benzathinum...................................... 1077Benzylpenicillinum kalicum.........................................5.2-3175Benzylpenicillinum natricum ......................................5.2-3177Benzylpenicillinum procainum .......................................... 1080Betacarotene ......................................................................5.6-4523Betacarotenum .................................................................5.6-4523Betacyclodextrin ...................................................................... 1084Betadex ...................................................................................... 1084Betadexum ................................................................................ 1084Betahistine dihydrochloride ...........................................5.1-2887Betahistine mesilate ................................................................ 1086Betahistini dihydrochloridum ......................................5.1-2887Betahistini mesilas ................................................................. 1086Betamethasone.........................................................................1087Betamethasone acetate .......................................................... 1089Betamethasone dipropionate .........................................5.3-3447Betamethasone sodium phosphate...................................... 1092Betamethasone valerate ..................................................5.3-3449Betamethasoni acetas ............................................................ 1089Betamethasoni dipropionas ..........................................5.3-3447Betamethasoni natrii phosphas .......................................... 1092Betamethasoni valeras....................................................5.3-3449Betamethasonum .................................................................... 1087Betaxolol hydrochloride .........................................................1095Betaxololi hydrochloridum................................................... 1095Betulae folium.......................................................................... 1103Bezafibrate ................................................................................ 1096Bezafibratum ............................................................................ 1096Bifonazole...........................................................................5.6-4523Bifonazolum ......................................................................5.6-4523Bilberry fruit, dried ................................................................. 1099Bilberry fruit, fresh.................................................................. 1099Biological assays (2.7.) .............................................................. 187Biological assays and tests, statistical analysis of (5.3.) .... 475Biological indicators of sterilisation (5.1.2.) ........................ 447Biological tests (2.6.) ................................................................. 145Biotin .......................................................................................... 1100Biotinum ................................................................................... 1100Biperiden hydrochloride..........................................................1101Biperideni hydrochloridum ..................................................1101Biphasic insulin injection....................................................... 1802Biphasic isophane insulin injection ..................................... 1803Birch leaf.................................................................................... 1103Bisacodyl.............................................................................5.8-5275Bisacodylum ......................................................................5.8-5275Bismuthi subcarbonas ........................................................... 1105



Bismuthi subgallas ................................................................. 1106Bismuthi subnitras ponderosum......................................... 1107Bismuthi subsalicylas ............................................................ 1107Bismuth subcarbonate............................................................ 1105Bismuth subgallate.................................................................. 1106Bismuth subnitrate, heavy ..................................................... 1107Bismuth subsalicylate ............................................................. 1107Bitter fennel ..............................................................................1580Bitter-fennel fruit oil................................................................ 1108Bitterness value (2.8.15.).......................................................... 221Bitter-orange epicarp and mesocarp.................................... 1110Bitter-orange-epicarp and mesocarp tincture .................... 1110Bitter-orange flower .................................................................1111Bitter-orange-flower oil ....................................................5.3-3562Black horehound ..................................................................... 1113Bleomycini sulfas .............................................................5.2-3179Bleomycin sulphate ..........................................................5.2-3179Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ..........................311

Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 269

Blood and blood components, sets for the transfusion of(3.2.6.) .........................................................................................313

Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 309

Blood, anticoagulant and preservative solutions for .......1007Blood, sterile containers of plasticised poly (vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 312

Bogbean leaf ............................................................................. 1115Boiling point (2.2.12.) ..................................................................31Boldi folium .......................................................................5.3-3450Boldo leaf............................................................................5.3-3450Borage (starflower) oil, refined......................................5.1-2889Borago officinalis oleum raffinatum ..........................5.1-2889Borax .......................................................................................... 1116Boric acid....................................................................................1117Botulinum antitoxin .................................................................. 801Botulinum toxin type A for injection....................................1117Bovine infectious rhinotracheitis vaccine (live),freeze-dried................................................................................ 768

Bovine insulin ....................................................................5.4-3955Bovine leptospirosis vaccine (inactivated)............................ 730Bovine parainfluenza virus vaccine (live), freeze-dried ..... 732Bovine respiratory syncytial virus vaccine (live),freeze-dried................................................................................ 733

Bovine serum.....................................................................5.4-3903Bovine tuberculin purified protein derivative ............5.7-5130Bovine viral diarrhoea vaccine (inactivated)........................ 734Bromazepam ......................................................................5.7-4971Bromazepamum ...............................................................5.7-4971Bromhexine hydrochloride .................................................... 1120Bromhexini hydrochloridum ............................................... 1120Bromocriptine mesilate ...................................................5.8-5276Bromocriptini mesilas ....................................................5.8-5276Bromperidol .............................................................................. 1124Bromperidol decanoate .......................................................... 1125Bromperidoli decanoas ......................................................... 1125Bromperidolum ....................................................................... 1124Brompheniramine maleate..................................................... 1127Brompheniramini maleas .................................................... 1127Brotizolam ..........................................................................5.7-4972Brotizolamum ...................................................................5.7-4972Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain),freeze-dried, for veterinary use ...................................5.1-2859

Buccal tablets and sublingual tablets...........................5.4-3847Buckwheat herb ................................................................5.8-5278Budesonide................................................................................ 1128Budesonidum ........................................................................... 1128Bufexamac ................................................................................. 1130

Bufexamacum .......................................................................... 1130Buffer solutions (4.1.3.) ...................................................5.7-4932Buflomedil hydrochloride ...................................................... 1131Buflomedili hydrochloridum ............................................... 1131Bumetanide ............................................................................... 1132Bumetanidum .......................................................................... 1132Bupivacaine hydrochloride .................................................... 1133Bupivacaini hydrochloridum............................................... 1133Buprenorphine ......................................................................... 1135Buprenorphine hydrochloride .............................................. 1136Buprenorphini hydrochloridum ......................................... 1136Buprenorphinum ................................................................... 1135Buserelin.............................................................................5.6-4529Buserelinum ......................................................................5.6-4529Buspirone hydrochloride.................................................5.3-3452Buspironi hydrochloridum............................................5.3-3452Busulfan..................................................................................... 1138Busulfanum .............................................................................. 1138Butcher’s broom................................................................5.3-3454Butylhydroxyanisole.................................................................1141Butylhydroxyanisolum ...........................................................1141Butylhydroxytoluene................................................................1141Butylhydroxytoluenum...........................................................1141Butylis parahydroxybenzoas................................................ 1140Butyl parahydroxybenzoate................................................... 1140

CCabergoline ........................................................................5.3-3459Cabergolinum ...................................................................5.3-3459Cachets ................................................................................5.5-4156Cadmii sulfas hydricusad praeparationes homoeopathicas..........................5.3-3429

Cadmium sulphate hydrate for homoeopathic prepara-tions ...................................................................................5.3-3429

Caffeine ...................................................................................... 1145Caffeine monohydrate............................................................. 1146Calcifediol .................................................................................. 1147Calcifediolum ........................................................................... 1147Calcii acetas ......................................................................5.1-2893Calcii ascorbas ..................................................................5.6-4535Calcii carbonas .................................................................5.1-2894Calcii chloridum dihydricum .............................................. 1152Calcii chloridum hexahydricum ......................................... 1153Calcii dobesilas monohydricum.......................................... 1153Calcii folinas ............................................................................ 1154Calcii glucoheptonas.............................................................. 1156Calcii gluconas ........................................................................ 1157Calcii gluconas ad iniectabile ............................................. 1158Calcii glycerophosphas.......................................................... 1159Calcii hydrogenophosphas anhydricus......................5.7-4977Calcii hydrogenophosphas dihydricus .......................5.7-4977Calcii hydroxidum .................................................................. 1161Calcii iodidum tetrahydricum ad praeparationeshomoeopathicas .............................................................5.2-3162

Calcii lactas anhydricus .................................................5.8-5283Calcii lactas monohydricus ...........................................5.8-5283Calcii lactas pentahydricus ...........................................5.8-5284Calcii lactas trihydricus .................................................5.8-5284Calcii laevulinas dihydricum............................................... 1165Calcii levofolinas pentahydricus .................................5.6-4536Calcii pantothenas .................................................................. 1166Calcii stearas ............................................................................ 1167Calcii sulfas dihydricus ......................................................... 1169Calcipotriol, anhydrous ...................................................5.3-3460Calcipotriol monohydrate ...............................................5.3-3462Calcipotriolum anhydricum..........................................5.3-3460Calcipotriolum monohydricum....................................5.3-3462Calcitonin (salmon)...........................................................5.6-4533Calcitoninum salmonis ..................................................5.6-4533



Calcitriol..................................................................................... 1149Calcitriolum.............................................................................. 1149Calcium (2.4.3.)........................................................................... 103Calcium acetate .................................................................5.1-2893Calcium ascorbate.............................................................5.6-4535Calcium carbonate ............................................................5.1-2894Calcium carboxymethylcellulose .......................................... 1188Calcium chloride dihydrate.................................................... 1152Calcium chloride hexahydrate .............................................. 1153Calcium dobesilate monohydrate ......................................... 1153Calcium folinate ....................................................................... 1154Calcium glucoheptonate......................................................... 1156Calcium gluconate ................................................................... 1157Calcium gluconate for injection............................................ 1158Calcium glycerophosphate..................................................... 1159Calcium hydrogen phosphate, anhydrous ...................5.7-4977Calcium hydrogen phosphate dihydrate ......................5.7-4977Calcium hydroxide ................................................................... 1161Calcium in adsorbed vaccines (2.5.14.) ..................................131Calcium iodide tetrahydrate for homoeopathicpreparations .....................................................................5.2-3162

Calcium lactate, anhydrous ............................................5.8-5283Calcium lactate monohydrate ........................................5.8-5283Calcium lactate pentahydrate ........................................5.8-5284Calcium lactate trihydrate...............................................5.8-5284Calcium levofolinate pentahydrate ...............................5.6-4536Calcium levulinate dihydrate................................................. 1165Calcium pantothenate............................................................. 1166Calcium phosphate ...........................................................5.8-5285Calcium stearate....................................................................... 1167Calcium sulphate dihydrate................................................... 1169Calendulae flos ........................................................................ 1169Calendula flower ...................................................................... 1169Calf coronavirus diarrhoea vaccine (inactivated)................ 736Calf rotavirus diarrhoea vaccine (inactivated)..................... 737Calicivirosis vaccine (inactivated), feline............................... 757Calicivirosis vaccine (live), feline, freeze-dried..................... 758Camphora racemica ............................................................... 1172Camphor, D- ............................................................................... 1170Camphor, racemic .................................................................... 1172Canine adenovirus vaccine (inactivated) .............................. 738Canine adenovirus vaccine (live) ............................................ 738Canine distemper vaccine (live), freeze-dried....................... 740Canine leptospirosis vaccine (inactivated)............................ 740Canine parainfluenza virus vaccine (live)............................. 742Canine parvovirosis vaccine (inactivated)............................. 743Canine parvovirosis vaccine (live) .......................................... 744Cape aloes.................................................................................... 948Capillary electrophoresis (2.2.47.).............................................74Capillary viscometer method (2.2.9.)....................................... 29Caprylic acid.............................................................................. 1172Caprylocaproyl macrogolglycerides..................................... 1173Capsici fructus ..................................................................5.8-5286Capsici oleoresina raffinata et quantificata .............5.8-5287Capsici tinctura normata ...............................................5.8-5288Capsicum.............................................................................5.8-5286Capsicum oleoresin, refined and quantified ...............5.8-5287Capsicum tincture, standardised ...................................5.8-5288Capsulae .............................................................................5.5-4155Capsules ..............................................................................5.5-4155Capsules and tablets, disintegration of (2.9.1.) ..........5.3-3351Capsules, gastro-resistant................................................5.5-4156Capsules, hard ...................................................................5.5-4155Capsules, intrauterine......................................................5.3-3397Capsules, modified-release ..............................................5.5-4156Capsules, oromucosal ......................................................5.4-3847Capsules, rectal..................................................................5.5-4163Capsules, soft .....................................................................5.5-4155Capsules, vaginal...............................................................5.5-4169

Captopril .............................................................................5.2-3185Captoprilum ......................................................................5.2-3185Caraway fruit............................................................................. 1177Caraway oil .........................................................................5.3-3467Carbachol................................................................................... 1177Carbacholum ............................................................................ 1177Carbamazepine ..................................................................5.6-4540Carbamazepinum ............................................................5.6-4540Carbasalate calcium................................................................. 1179Carbasalatum calcicum ......................................................... 1179Carbidopa .................................................................................. 1180Carbidopum .............................................................................. 1180Carbimazole .............................................................................. 1182Carbimazolum ......................................................................... 1182Carbo activatus ........................................................................1246Carbocisteine ............................................................................ 1182Carbocisteinum ....................................................................... 1182Carbomera ................................................................................ 1183Carbomers ................................................................................. 1183Carbon dioxide ......................................................................... 1185Carbon dioxide in gases (2.5.24.) ........................................... 134Carbonei dioxidum ................................................................. 1185Carbonei monoxidum (15O) .....................................................818Carbon monoxide (15O) ..............................................................818Carbon monoxide in gases (2.5.25.)....................................... 134Carboplatin................................................................................ 1186Carboplatinum ......................................................................... 1186Carboprost trometamol ...................................................5.5-4201Carboprostum trometamolum ......................................5.5-4201Carboxymethylamylum natricum A............................5.4-4018Carboxymethylamylum natricum B............................5.4-4019Carboxymethylamylum natricum C................................... 2451Carboxymethylcellulose calcium .......................................... 1188Carboxymethylcellulose sodium........................................... 1189Carboxymethylcellulose sodium, cross-linked ............5.7-5000Carboxymethylcellulose sodium, low-substituted............. 1190Carisoprodol.............................................................................. 1187Carisoprodolum....................................................................... 1187Carmellose calcium.................................................................. 1188Carmellose sodium .................................................................. 1189Carmellose sodium, low-substituted .................................... 1190Carmellosum calcicum .......................................................... 1188Carmellosum natricum ......................................................... 1189Carmellosum natricum conexum ................................5.7-5000Carmellosum natricum, substitutum humile................... 1190Carmustine ................................................................................ 1191Carmustinum ........................................................................... 1191Carnauba wax ........................................................................... 1191Carteolol hydrochloride.......................................................... 1192Carteololi hydrochloridum ................................................... 1192Carthami oleum raffinatum .................................................2389Carvedilol................................................................................... 1193Carvedilolum ............................................................................ 1193Carvi aetheroleum ...........................................................5.3-3467Carvi fructus............................................................................. 1177Caryophylli floris aetheroleum ...........................................1335Caryophylli flos .......................................................................1334Cascara ....................................................................................... 1194Cascara dry extract, standardised .................................5.6-4542Cassia oil .................................................................................... 1196Castor oil, hydrogenated .................................................5.8-5289Castor oil, polyoxyl ...........................................................5.3-3547Castor oil, polyoxyl hydrogenated.................................5.2-3231Castor oil, refined .............................................................5.8-5290Castor oil, virgin....................................................................... 1197Catgut, sterile.............................................................................. 873Catgut, sterile, in distributor for veterinary use ................. 885CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.).........................................................................5.6-4421



Cefaclor ...............................................................................5.3-3470Cefaclorum ........................................................................5.3-3470Cefadroxil monohydrate ..................................................5.3-3471Cefadroxilum monohydricum ......................................5.3-3471Cefalexin monohydrate...........................................................1202Cefalexinum monohydricum ...............................................1202Cefalotin sodium ...............................................................5.8-5291Cefalotinum natricum ....................................................5.8-5291Cefamandole nafate .................................................................1204Cefamandoli nafas ..................................................................1204Cefapirin sodium......................................................................1206Cefapirinum natricum...........................................................1206Cefatrizine propylene glycol..................................................1207Cefatrizinum propylen glycolum........................................1207Cefazolin sodium...............................................................5.7-4978Cefazolinum natricum....................................................5.7-4978Cefepime dihydrochloride monohydrate .....................5.6-4543Cefepimi dihydrochloridum monohydricum............5.6-4543Cefixime ..................................................................................... 1211Cefiximum................................................................................. 1211Cefoperazone sodium ............................................................. 1212Cefoperazonum natricum..................................................... 1212Cefotaxime sodium ...........................................................5.4-3912Cefotaximum natricum ..................................................5.4-3912Cefoxitin sodium ...................................................................... 1216Cefoxitinum natricum ........................................................... 1216Cefradine.............................................................................5.5-4202Cefradinum ........................................................................5.5-4202Ceftazidime................................................................................ 1218Ceftazidimum........................................................................... 1218Ceftriaxone sodium...........................................................5.7-4981Ceftriaxonum natricum..................................................5.7-4981Cefuroxime axetil ..............................................................5.7-4982Cefuroxime sodium...........................................................5.7-4984Cefuroximum axetili........................................................5.7-4982Cefuroximum natricum..................................................5.7-4984Celiprolol hydrochloride..................................................5.3-3473Celiprololi hydrochloridum...........................................5.3-3473Cell cultures for the production of veterinary vaccines(5.2.4.) ........................................................................................ 458

Cell substrates for the production of vaccines for human use(5.2.3.) ........................................................................................ 455

Cellulae stirpes haematopoieticae humanae............5.6-4598Cellular products, microbiological control of(2.6.27.) .............................................................................5.6-4414

Cellulose acetate ......................................................................1226Cellulose acetate butyrate......................................................1227Cellulose acetate phthalate....................................................1227Cellulose, microcrystalline..............................................5.7-4985Cellulose, powdered .........................................................5.7-4989Cellulosi acetas ........................................................................1226Cellulosi acetas butyras .........................................................1227Cellulosi acetas phthalas.......................................................1227Cellulosi pulvis .................................................................5.7-4989Cellulosum microcristallinum ......................................5.7-4985Centaurii herba ................................................................5.5-4204Centaury .............................................................................5.5-4204Centella ......................................................................................1236Centellae asiaticae herba ......................................................1236Cera alba ............................................................................5.4-3901Cera carnauba ......................................................................... 1191Cera flava ...........................................................................5.4-3902Cetirizine dihydrochloride ..............................................5.4-3916Cetirizini dihydrochloridum .........................................5.4-3916Cetobemidoni hydrochloridum ........................................... 1871Cetostearyl alcohol ...........................................................5.3-3474Cetostearyl alcohol (type A), emulsifying ....................5.6-4545Cetostearyl alcohol (type B), emulsifying....................5.6-4546Cetostearylis isononanoas....................................................1242

Cetostearyl isononanoate.......................................................1242Cetrimide ...................................................................................1243Cetrimidum...............................................................................1243Cetyl alcohol ......................................................................5.3-3475Cetylis palmitas .......................................................................1244Cetyl palmitate..........................................................................1244Cetylpyridinii chloridum ......................................................1244Cetylpyridinium chloride........................................................1244Ceylon cinnamon bark oil ......................................................1295Ceylon cinnamon leaf oil........................................................1296Chamomile flower, Roman.....................................................1245Chamomillae romanae flos ..................................................1245Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ...........5.6-4432

Characters section in monographs (5.11.)............................ 565Charcoal, activated ..................................................................1246Chelidonii herba...................................................................... 1690Chenodeoxycholic acid ..........................................................1247Chewing gum, medicated, dissolution test for(2.9.25.) .............................................................................5.2-3116

Chewing gums, medicated ..............................................5.2-3136Chicken flocks free from specified pathogens forthe production and quality control of vaccines(5.2.2.) ...............................................................................5.1-2825

Chicken infectious anaemia vaccine (live) ............................ 769Chinidini sulfas .......................................................................2347Chinini hydrochloridum .......................................................2348Chinini sulfas ...........................................................................2350Chitosan hydrochloride ..........................................................1248Chitosani hydrochloridum ...................................................1248Chlamydiosis vaccine (inactivated), feline ..................5.6-4489Chloral hydrate.........................................................................1249Chlorali hydras ........................................................................1249Chlorambucil.............................................................................1250Chlorambucilum......................................................................1250Chloramine ................................................................................2605Chloramphenicol......................................................................1250Chloramphenicoli natrii succinas ......................................1252Chloramphenicoli palmitas ...........................................5.4-3918Chloramphenicol palmitate ............................................5.4-3918Chloramphenicol sodium succinate.....................................1252Chloramphenicolum...............................................................1250Chlorcyclizine hydrochloride ................................................1253Chlorcyclizini hydrochloridum ...........................................1253Chlordiazepoxide ..............................................................5.2-3186Chlordiazepoxide hydrochloride ...................................5.2-3188Chlordiazepoxidi hydrochloridum ..............................5.2-3188Chlordiazepoxidum .........................................................5.2-3186Chlorhexidine diacetate..........................................................1256Chlorhexidine digluconate solution ....................................1258Chlorhexidine dihydrochloride .............................................1259Chlorhexidini diacetas...........................................................1256Chlorhexidini digluconatis solutio.....................................1258Chlorhexidini dihydrochloridum........................................1259Chlorides (2.4.4.) ........................................................................ 104Chlorobutanol, anhydrous ..................................................... 1261Chlorobutanol hemihydrate .................................................. 1261Chlorobutanolum anhydricum............................................ 1261Chlorobutanolum hemihydricum ....................................... 1261Chlorocresol ..............................................................................1262Chlorocresolum .......................................................................1262Chloroquine phosphate ..........................................................1262Chloroquine sulphate.......................................................5.5-4205Chloroquini phosphas ...........................................................1262Chloroquini sulfas............................................................5.5-4205Chlorothiazide ..........................................................................1264Chlorothiazidum .....................................................................1264Chlorphenamine maleate ................................................5.3-3476Chlorphenamini maleas.................................................5.3-3476



Chlorpromazine hydrochloride......................................5.3-3477Chlorpromazini hydrochloridum ................................5.3-3477Chlorpropamide........................................................................1266Chlorpropamidum ..................................................................1266Chlorprothixene hydrochloride ............................................1267Chlorprothixeni hydrochloridum .......................................1267Chlortalidone .....................................................................5.3-3478Chlortalidonum ................................................................5.3-3478Chlortetracycline hydrochloride...........................................1270Chlortetracyclini hydrochloridum......................................1270Cholecalciferol ..........................................................................1272Cholecalciferol concentrate (oily form)........................5.6-4548Cholecalciferol concentrate (powder form).................5.6-4549Cholecalciferol concentrate (water-dispersibleform) ..................................................................................5.6-4551

Cholecalciferoli pulvis ....................................................5.6-4549Cholecalciferolum ...................................................................1272Cholecalciferolum densatum oleosum .......................5.6-4548Cholecalciferolum in aqua dispergibile .....................5.6-4551Cholera vaccine .......................................................................... 637Cholera vaccine, freeze-dried .................................................. 638Cholesterol ................................................................................1279Cholesterol in oils rich in omega-3 acids, total(2.4.32.) .............................................................................5.8-5197

Cholesterolum ..........................................................................1279Chondroitini natrii sulfas ..............................................5.6-4553Chondroitin sulphate sodium.........................................5.6-4553Chorda resorbilis sterilis ......................................................... 873Chorda resorbilis sterilis in fuso ad usum veterinarium .. 885Chromatographic separation techniques (2.2.46.) ............... 69Chromatography, gas (2.2.28.).................................................. 42Chromatography, liquid (2.2.29.) ............................................. 43Chromatography, paper (2.2.26.).............................................. 40Chromatography, size-exclusion (2.2.30.)............................... 45Chromatography, supercritical fluid (2.2.45.) ....................... 68Chromatography, thin-layer (2.2.27.) ............................5.2-3090Chromii (51Cr) edetatis solutio iniectabilis ..........................819Chromium (51Cr) edetate injection ..........................................819Chymotrypsin.....................................................................5.6-4555Chymotrypsinum .............................................................5.6-4555Ciclopirox...................................................................................1282Ciclopirox olamine ...................................................................1283Ciclopirox olaminum .............................................................1283Ciclopiroxum............................................................................1282Ciclosporin .........................................................................5.7-4992Ciclosporinum ..................................................................5.7-4992Cilastatin sodium ..............................................................5.8-5292Cilastatinum natricum ...................................................5.8-5292Cilazapril ....................................................................................1288Cilazaprilum ............................................................................1288Cimetidine..................................................................................1289Cimetidine hydrochloride.......................................................1290Cimetidini hydrochloridum .................................................1290Cimetidinum ............................................................................1289Cinchocaine hydrochloride.................................................... 1291Cinchocaini hydrochloridum .............................................. 1291Cinchona bark ..........................................................................1292Cinchonae cortex ....................................................................1292Cinchonae extractum fluidum normatum ................5.4-3919Cinchona liquid extract, standardised..........................5.4-3919Cineole........................................................................................1294Cineole in essential oils, assay of, 1,8- (2.8.11.) ....................216Cineolum ...................................................................................1294Cinnamomi cassiae aetheroleum ....................................... 1196Cinnamomi cortex ..................................................................1295Cinnamomi corticis tinctura................................................1297Cinnamomi zeylanici folii aetheroleum ...........................1296Cinnamomi zeylanicii corticis aetheroleum ...................1295Cinnamon ..................................................................................1295

Cinnamon bark oil, Ceylon ....................................................1295Cinnamon leaf oil, Ceylon ......................................................1296Cinnamon tincture...................................................................1297Cinnarizine ................................................................................1297Cinnarizinum ..........................................................................1297Ciprofibrate ...............................................................................1299Ciprofibratum...........................................................................1299Ciprofloxacin.............................................................................1300Ciprofloxacin hydrochloride..................................................1302Ciprofloxacini hydrochloridum ..........................................1302Ciprofloxacinum .....................................................................1300Circular dichroism (2.2.41.) ....................................................... 63Cisapride monohydrate...........................................................1303Cisapride tartrate .....................................................................1304Cisapridi tartras ......................................................................1304Cisapridum monohydricum .................................................1303Cisplatin .....................................................................................1306Cisplatinum ..............................................................................1306Citric acid, anhydrous .............................................................1306Citric acid monohydrate .........................................................1307Citri reticulatae aetheroleum........................................5.6-4630Citronellae aetheroleum........................................................1308Citronella oil..............................................................................1308Cladribine ...........................................................................5.7-4994Cladribinum ......................................................................5.7-4994Clarithromycin...................................................................5.1-2900Clarithromycinum ...........................................................5.1-2900Clarity and degree of opalescence of liquids (2.2.1.) ..5.7-4777Clary sage oil............................................................................. 1311Clazuril for veterinary use ..................................................... 1312Clazurilum ad usum veterinarium..................................... 1312Clebopride malate .................................................................... 1314Clebopridi malas ..................................................................... 1314Clemastine fumarate ............................................................... 1315Clemastini fumaras ................................................................ 1315Clenbuterol hydrochloride..............................................5.1-2902Clenbuteroli hydrochloridum .......................................5.1-2902Clindamycin hydrochloride.............................................5.4-3920Clindamycini hydrochloridum .....................................5.4-3920Clindamycini phosphas......................................................... 1319Clindamycin phosphate .......................................................... 1319Clioquinol .................................................................................. 1321Clioquinolum ........................................................................... 1321Clobazam ...................................................................................1322Clobazamum ............................................................................1322Clobetasoli propionas .....................................................5.5-4208Clobetasol propionate......................................................5.5-4208Clobetasone butyrate ..............................................................1323Clobetasoni butyras ................................................................1323Clofazimine................................................................................1324Clofaziminum ..........................................................................1324Clofibrate ...................................................................................1325Clofibratum ...............................................................................1325Clomifene citrate ......................................................................1326Clomifeni citras .......................................................................1326Clomipramine hydrochloride.................................................1328Clomipramini hydrochloridum ...........................................1328Clonazepam...............................................................................1330Clonazepamum .......................................................................1330Clonidine hydrochloride......................................................... 1331Clonidini hydrochloridum.................................................... 1331Closantel sodium dihydrate for veterinary use ..........5.1-2903Closantelum natricum dihydricumad usum veterinarium ..................................................5.1-2903

Clostridium botulinum vaccine for veterinary use ............. 745Clostridium chauvoei vaccine for veterinary use................ 745Clostridium novyi alpha antitoxin for veterinary use ........5.1-2865

Clostridium novyi (type B) vaccine for veterinary use....... 746



Clostridium perfringens beta antitoxin for veterinary use............................................................................................5.1-2866

Clostridium perfringens epsilon antitoxin for veterinary use............................................................................................5.1-2867

Clostridium perfringens vaccine for veterinary use ........... 747Clostridium septicum vaccine for veterinary use................ 749Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282

Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308

Closures and tubing, silicone elastomer for (3.1.9.) ........... 288Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) .........................................................................................316

Clotrimazole..............................................................................1333Clotrimazolum .........................................................................1333Clove ...........................................................................................1334Clove oil .....................................................................................1335Cloxacillin sodium.............................................................5.7-4996Cloxacillinum natricum .................................................5.7-4996Clozapine ...................................................................................1337Clozapinum ..............................................................................1337Coagulation factor II, assay of (2.7.18.)................................. 209Coagulation factor IX, human............................................... 1738Coagulation factor IX, human, assay of (2.7.11.)........5.5-4120Coagulation factors, activated (2.6.22.)........................5.5-4115Coagulation factors, assay of heparin (2.7.12.) ................... 204Coagulation factor VII, human ............................................. 1734Coagulation factor VII, human, assay of (2.7.10.) ......5.6-4419Coagulation factor VIII, human.....................................5.6-4596Coagulation factor VIII, human, assay of (2.7.4.).......5.5-4119Coagulation factor VIII (rDNA), human ............................. 1737Coagulation factor X, assay of (2.7.19.) ..................................210Coagulation factor XI, human........................................5.5-4246Coagulation factor XI, human, assay of (2.7.22.) .......5.5-4121Coated granules ................................................................ 5.2-3141Coated tablets ....................................................................5.8-5240Cocaine hydrochloride............................................................1338Cocaini hydrochloridum .......................................................1338Cocois oleum raffinatum.......................................................1339Coconut oil, refined.................................................................1339Cocoyl caprylocaprate......................................................5.2-3189Cocoylis caprylocapras...................................................5.2-3189Codeine ...............................................................................5.1-2905Codeine hydrochloride dihydrate..................................5.1-2906Codeine phosphate hemihydrate...................................5.1-2908Codeine phosphate sesquihydrate ................................5.1-2909Codeini hydrochloridum dihydricum.........................5.1-2906Codeini phosphas hemihydricus .................................5.1-2908Codeini phosphas sesquihydricus ...............................5.1-2909Codeinum ...........................................................................5.1-2905Codergocrine mesilate ............................................................1347Codergocrini mesilas .............................................................1347Cod-liver oil (type A)................................................................1348Cod-liver oil (type B)................................................................1352Coffeinum.................................................................................. 1145Coffeinum monohydricum ................................................... 1146Cola .............................................................................................1356Colae semen .............................................................................1356Colchicine ..................................................................................1357Colchicinum .............................................................................1357Colestyramine ....................................................................5.5-4210Colestyraminum ...............................................................5.5-4210Colibacillosis vaccine (inactivated), neonatal piglet........... 776Colibacillosis vaccine (inactivated), neonatal ruminant .... 778Colistimethate sodium .....................................................5.7-4997Colistimethatum natricum ............................................5.7-4997Colistini sulfas ..................................................................5.7-4998Colistin sulphate ...............................................................5.7-4998

Colloidal anhydrous silica ...................................................... 2410Colloidal anhydrous silica, hydrophobic......................5.8-5362Colloidal hydrated silica ......................................................... 2411Colloidal silver, for external use ....................................5.3-3613Colophonium ...........................................................................1362Colophony .................................................................................1362Coloration of liquids (2.2.2.)...................................................... 24Common stinging nettle for homoeopathicpreparations .....................................................................5.3-3429

Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................17

Complexometric titrations (2.5.11.)........................................ 130Composition of fatty acids by gas chromatography(2.4.22.) .............................................................................5.6-4389

Composition of fatty acids in oils rich in omega-3-acids(2.4.29.) .............................................................................5.5-4107

Compressed lozenges.......................................................5.4-3846Compressi...........................................................................5.8-5239Concentrated solutions for haemodialysis ......................... 1700Concentrates for injections or infusions......................5.2-3145Concentrates for intrauterine solutions.......................5.3-3397Conductivity (2.2.38.) .......................................................5.1-2783Coneflower herb, purple .................................................5.7-5098Coneflower root, narrow-leaved.....................................5.7-5064Coneflower root, pale.......................................................5.7-5085Coneflower root, purple ..................................................5.7-5100Conjugated estrogens .............................................................1539Containers (3.2.)................................................................5.6-4443Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 282

Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 308

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 296

Containers for aqueous solutions for parenteral infusion,plastic (3.2.2.1.) ........................................................................ 309

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)....................................................................................... 291

Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 269

Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 269

Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 309

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 289

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 279

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 278

Containers for pharmaceutical use, glass (3.2.1.)............... 303Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 298

Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) .........311

Containers of plasticised poly (vinyl chloride) for humanblood containing anticoagulant solution, sterile (3.2.5.).. 312

Contamination, microbial: test for specified micro-organisms(2.6.13.) .............................................................................5.6-4404

Contamination, microbial: total viable aerobic count(2.6.12.) .............................................................................5.6-4398

Content uniformity of single-dose preparations (2.9.6.).... 234



Control of impurities in substances for pharmaceutical use(5.10.).................................................................................5.5-4145

Control of microbiological quality, alternative methods for(5.1.6.)................................................................................5.5-4131

Copolymer, methacrylic acid - ethyl acrylate (1:1) ....5.7-5050Copolymer (type A), ammonio methacrylate ..............5.6-4504Copolymer (type B), ammonio methacrylate ..............5.6-4505Copolymerum methacrylatis butylati basicum ............... 1053Copovidone................................................................................1363Copovidonum ...........................................................................1363Copper acetate monohydrate for homoeopathicpreparations .....................................................................5.2-3162

Copper for homoeopathic preparations................................ 896Copper sulphate, anhydrous..................................................1364Copper sulphate pentahydrate..............................................1365Coriander ...................................................................................1365Coriander oil .............................................................................1366Coriandri aetheroleum ..........................................................1366Coriandri fructus ....................................................................1365Corpora ad usum pharmaceuticum ............................5.8-5229Cortisone acetate .....................................................................1367Cortisoni acetas .......................................................................1367Cotton, absorbent ....................................................................1369Cottonseed oil, hydrogenated ..............................................1370Couch grass rhizome .............................................................. 1371Crataegi folii cum floreextractum fluidum quantificatum .............................5.3-3511

Crataegi folii cum flore extractum siccum ....................... 1714Crataegi folium cum flore..................................................... 1713Crataegi fructus ....................................................................... 1712Creams.................................................................................5.5-4165Cresol, crude ............................................................................. 1371Cresolum crudum ................................................................... 1371Croci stigma ad praeparationes homoeopathicas ............ 900Croscarmellose sodium....................................................5.7-5000Crospovidone ............................................................................1373Crospovidonum .......................................................................1373Crotamiton ................................................................................ 1374Crotamitonum.......................................................................... 1374Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.) ......5.6-4432

Cupri acetas monohydricus ad praeparationeshomoeopathicas .............................................................5.2-3162

Cupri sulfas anhydricus ........................................................1364Cupri sulfas pentahydricus ..................................................1365Cuprum ad praeparationes homoeopathicas .................... 896Curcumae xanthorrhizae rhizoma.....................................2645Cutaneous application, liquid preparations for..........5.5-4159Cutaneous application, powders for .............................5.2-3147Cutaneous application, semi-solid preparations for ..5.5-4164Cutaneous application, veterinary liquid preparationsfor ................................................................................................ 630

Cutaneous foams...............................................................5.5-4160Cyamopsidis seminis pulvis ................................................. 1694Cyanocobalamin ................................................................5.6-4558Cyanocobalamin (57Co) capsules .............................................819Cyanocobalamin (57Co) solution ............................................. 820Cyanocobalamin (58Co) capsules ............................................ 821Cyanocobalamin (58Co) solution ............................................. 822Cyanocobalamini (57Co) capsulae .........................................819Cyanocobalamini (57Co) solutio ............................................ 820Cyanocobalamini (58Co) capsulae ........................................ 821Cyanocobalamini (58Co) solutio ............................................ 822Cyanocobalaminum ........................................................5.6-4558Cyclizine hydrochloride .......................................................... 1376Cyclizini hydrochloridum..................................................... 1376Cyclopentolate hydrochloride ...............................................1377Cyclopentolati hydrochloridum ..........................................1377Cyclophosphamide...................................................................1378

Cyclophosphamidum .............................................................1378Cynarae folium .................................................................5.7-4966Cyproheptadine hydrochloride .............................................1379Cyproheptadini hydrochloridum ........................................1379Cyproterone acetate ................................................................1380Cyproteroni acetas..................................................................1380Cysteine hydrochloride monohydrate ................................. 1381Cysteini hydrochloridum monohydricum ........................ 1381Cystine........................................................................................1382Cystinum ...................................................................................1382Cytarabine .................................................................................1383Cytarabinum.............................................................................1383

DDalteparin sodium ............................................................5.4-3925Dalteparinum natricum .................................................5.4-3925Danaparoid sodium ..........................................................5.5-4215Danaparoidum natricum ...............................................5.5-4215Dapsone .....................................................................................1388Dapsonum .................................................................................1388Daunorubicin hydrochloride .................................................1389Daunorubicini hydrochloridum..........................................1389D-Camphor ................................................................................. 1170D-Camphora .............................................................................. 1170Decylis oleas .............................................................................1390Decyl oleate ...............................................................................1390Deferoxamine mesilate............................................................1390Deferoxamini mesilas ............................................................1390Degree of coloration of liquids (2.2.2.).................................... 24Deliverable mass or volume of liquid and semi-solidpreparations, test for (2.9.28.)............................................... 263

Dembrexine hydrochloride monohydrate for veteri-nary use ............................................................................5.6-4563

Dembrexini hydrochloridum monohydricum ad usumveterinarium ...................................................................5.6-4563

Demeclocycline hydrochloride..............................................1392Demeclocyclini hydrochloridum ........................................1392Density of solids (2.2.42.) ........................................................... 64Density, relative (2.2.5.) .............................................................. 27Dental type silica...................................................................... 2411Depressor substances (2.6.11.)................................................ 153Deptropine citrate....................................................................1393Deptropini citras .....................................................................1393Dequalinii chloridum.............................................................1394Dequalinium chloride..............................................................1394Desipramine hydrochloride ...................................................1395Desipramini hydrochloridum ..............................................1395Deslanoside ...............................................................................1396Deslanosidum ..........................................................................1396Desmopressin.....................................................................5.8-5297Desmopressinum..............................................................5.8-5297Desogestrel .........................................................................5.5-4217Desogestrelum...................................................................5.5-4217Desoxycortone acetate............................................................1399Desoxycortoni acetas .............................................................1399Detector tubes, gas (2.1.6.) .........................................................19Determination of aflatoxin B1 in herbal drugs(2.8.18.) .............................................................................5.7-4801

Determination of essential oils in vegetable drugs(2.8.12.) .......................................................................................217

Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 129

Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 129

Determination of tannins in herbal drugs (2.8.14.)............ 221Determination of water by distillation (2.2.13.) .................... 32Detomidine hydrochloride for veterinary use ................... 1400Detomidini hydrochloridum ad usum veterinarium ..... 1400Devil’s claw root ....................................................................... 1401



Dexamethasone ........................................................................ 1402Dexamethasone acetate.......................................................... 1403Dexamethasone isonicotinate ........................................5.4-3927Dexamethasone sodium phosphate ..................................... 1404Dexamethasoni acetas ........................................................... 1403Dexamethasoni isonicotinas .........................................5.4-3927Dexamethasoni natrii phosphas ......................................... 1404Dexamethasonum ................................................................... 1402Dexchlorpheniramine maleate .............................................. 1406Dexchlorpheniramini maleas .............................................. 1406Dexpanthenol............................................................................ 1407Dexpanthenolum..................................................................... 1407Dextran 1 for injection............................................................ 1408Dextran 40 for injection ......................................................... 1409Dextran 60 for injection ......................................................... 1410Dextran 70 for injection ..........................................................1411Dextrans, molecular mass distribution in (2.2.39.) .............. 57Dextranum 1 ad iniectabile ................................................. 1408Dextranum 40 ad iniectabile ............................................... 1409Dextranum 60 ad iniectabile ............................................... 1410Dextranum 70 ad iniectabile ................................................1411Dextrin........................................................................................ 1412Dextrinum ................................................................................. 1412Dextromethorphan hydrobromide ....................................... 1412Dextromethorphani hydrobromidum ................................ 1412Dextromoramide tartrate ........................................................1414Dextromoramidi tartras..........................................................1414Dextropropoxyphene hydrochloride.....................................1414Dextropropoxypheni hydrochloridum................................1414Diazepam ............................................................................5.6-4564Diazepamum .....................................................................5.6-4564Diazoxide ................................................................................... 1416Diazoxidum .............................................................................. 1416Dibrompropamidine diisetionate ...................................5.4-3928Dibrompropamidini diisetionas ...................................5.4-3928Dibutylis phthalas ....................................................................1417Dibutyl phthalate ......................................................................1417Dichloromethane...................................................................... 2017Diclazuril for veterinary use.................................................. 1418Diclazurilum ad usum veterinarium ................................. 1418Diclofenac potassium .............................................................. 1419Diclofenac sodium ................................................................... 1420Diclofenacum kalicum........................................................... 1419Diclofenacum natricum ........................................................ 1420Dicloxacillin sodium ................................................................ 1422Dicloxacillinum natricum..................................................... 1422Dicycloverine hydrochloride.................................................. 1423Dicycloverini hydrochloridum ............................................ 1423Didanosine..........................................................................5.2-3193Didanosinum.....................................................................5.2-3193Dienestrol .................................................................................. 1424Dienestrolum ............................................................................ 1424Diethylcarbamazine citrate .................................................... 1426Diethylcarbamazini citras .................................................... 1426Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095

Diethylene glycol monoethyl ether...................................... 1426Diethylene glycol palmitostearate .................................5.2-3194Diethylenglycoli monoethylicum aetherum .................... 1426Diethylenglycoli palmitostearas...................................5.2-3194Diethylis phthalas ................................................................... 1425Diethyl phthalate ..................................................................... 1425Diethylstilbestrol ...................................................................... 1429Diethylstilbestrolum ............................................................... 1429Diffraction, laser light, particle size analysis by(2.9.31.) ............................................................................5.6-4429

Diflunisal.................................................................................... 1429Diflunisalum ............................................................................ 1429Digitalis leaf .............................................................................. 1431

Digitalis purpureae folium ................................................... 1431Digitoxin..................................................................................... 1432Digitoxinum.............................................................................. 1432Digoxin ................................................................................5.8-5298Digoxinum .........................................................................5.8-5298Dihydralazine sulphate, hydrated ........................................ 1434Dihydralazini sulfas hydricus.............................................. 1434Dihydrocodeine hydrogen tartrate....................................... 1435Dihydrocodeini hydrogenotartras ...................................... 1435Dihydroergocristine mesilate ................................................ 1437Dihydroergocristini mesilas ................................................. 1437Dihydroergotamine mesilate ................................................. 1439Dihydroergotamine tartrate .................................................. 1440Dihydroergotamini mesilas .................................................. 1439Dihydroergotamini tartras.................................................... 1440Dihydrostreptomycini sulfas ad usum veterinarium.......5.8-5300

Dihydrostreptomycin sulphate for veterinary use .....5.8-5300Dihydrotachysterol ...........................................................5.3-3487Dihydrotachysterolum ....................................................5.3-3487Dikalii clorazepas ................................................................... 1457Dikalii phosphas...................................................................... 1458Diltiazem hydrochloride ......................................................... 1443Diltiazemi hydrochloridum .................................................. 1443Dimenhydrinate........................................................................ 1444Dimenhydrinatum .................................................................. 1444Dimercaprol............................................................................... 1445Dimercaprolum........................................................................ 1445Dimethylacetamide ...........................................................5.1-2915Dimethylacetamidum......................................................5.1-2915Dimethylaniline, N,N- (2.4.26.) .................................................119Dimethylis sulfoxidum........................................................... 1445Dimethyl sulfoxide ................................................................... 1445Dimeticone ................................................................................ 1447Dimeticonum............................................................................ 1447Dimetindene maleate .............................................................. 1448Dimetindeni maleas ............................................................... 1448Dinatrii edetas ..................................................................5.4-3929Dinatrii etidronas ............................................................5.5-4227Dinatrii pamidronas pentahydricus ...........................5.4-4003Dinatrii phosphas anhydricus............................................. 1463Dinatrii phosphas dihydricus .............................................. 1464Dinatrii phosphas dodecahydricus .............................5.1-2916Dinitrogenii oxidum........................................................5.7-5067Dinoprostone ............................................................................ 1450Dinoprostonum........................................................................ 1450Dinoprost trometamol............................................................. 1449Dinoprostum trometamolum ............................................... 1449Diosmin ...................................................................................... 1452Diosminum ............................................................................... 1452Dioxan and ethylene oxide (2.4.25.) .......................................118Dip concentrates ........................................................................ 630Diphenhydramine hydrochloride.......................................... 1454Diphenhydramini hydrochloridum .................................... 1454Diphenoxylate hydrochloride ................................................ 1455Diphenoxylati hydrochloridum ........................................... 1455Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ....................................5.6-4424

Diphtheria and tetanus vaccine (adsorbed) ......................... 639Diphtheria and tetanus vaccine (adsorbed) for adults andadolescents.......................................................................5.6-4480

Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content).............................................................................5.6-4480

Diphtheria antitoxin .................................................................. 801Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851

Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 643



Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ......................5.4-3854

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3856

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4483

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3858

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................5.4-3861

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)..........................................................5.4-3864

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866

Diphtheria vaccine (adsorbed) ................................................ 660Diphtheria vaccine (adsorbed), assay of (2.7.6.) .........5.7-4789Diphtheria vaccine (adsorbed) for adults andadolescents.......................................................................5.6-4485

Diphtheria vaccine (adsorbed, reduced antigencontent).............................................................................5.6-4485

Dipivefrine hydrochloride ...............................................5.5-4220Dipivefrini hydrochloridum ..........................................5.5-4220Dipotassium clorazepate ........................................................ 1457Dipotassium phosphate .......................................................... 1458Diprophylline ............................................................................ 1459Diprophyllinum ....................................................................... 1459Dipyridamole............................................................................. 1460Dipyridamolum ....................................................................... 1460Dirithromycin............................................................................ 1461Dirithromycinum .................................................................... 1461Disintegration of suppositories and pessaries (2.9.2.) ....... 227Disintegration of tablets and capsules (2.9.1.) ...........5.3-3351Disodium edetate ..............................................................5.4-3929Disodium phosphate, anhydrous.......................................... 1463Disodium phosphate dihydrate............................................. 1464Disodium phosphate dodecahydrate ............................5.1-2916Disopyramide ............................................................................ 1465Disopyramide phosphate........................................................ 1466Disopyramidi phosphas......................................................... 1466Disopyramidum ....................................................................... 1465Dispersible tablets ............................................................5.8-5240Dissolution, apparent (2.9.43.).......................................5.6-4438Dissolution, intrinsic (2.9.29.) ........................................5.4-3705Dissolution test for lipophilic solid dosage forms(2.9.42.) .............................................................................5.3-3373

Dissolution test for medicated chewing gums (2.9.25.)............................................................................................5.2-3116

Dissolution test for solid dosage forms (2.9.3.) ..........5.7-4805Dissolution test for transdermal patches (2.9.4.)................ 231Distemper vaccine (live), canine, freeze-dried...................... 740Distemper vaccine (live) for mustelids, freeze-dried........... 751Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38.) .............................................................................5.3-3368

Disulfiram .................................................................................. 1467Disulfiramum ........................................................................... 1467Dithranol.................................................................................... 1468Dithranolum ............................................................................. 1468DL-Methionine ........................................................................... 2010DL-Methioninum ...................................................................... 2010DL-α-Tocopheryl hydrogen succinate............................5.6-4695DL-α-Tocopherylis hydrogenosuccinas.......................5.6-4695

Dobutamine hydrochloride.................................................... 1469Dobutamini hydrochloridum ............................................... 1469Docusate sodium...............................................................5.6-4565Dodecyl gallate ......................................................................... 1472Dodecylis gallas ....................................................................... 1472Dog rose ..................................................................................... 1472Domperidone ............................................................................ 1473Domperidone maleate ............................................................. 1475Domperidoni maleas .............................................................. 1475Domperidonum ....................................................................... 1473Dopamine hydrochloride........................................................ 1476Dopamini hydrochloridum................................................... 1476Dopexamine dihydrochloride .........................................5.8-5302Dopexamini dihydrochloridum....................................5.8-5302Dosage units, uniformity of (2.9.40.) ............................5.3-3370Dosulepin hydrochloride........................................................ 1477Dosulepini hydrochloridum ................................................. 1477Doxapram hydrochloride........................................................ 1479Doxaprami hydrochloridum ................................................ 1479Doxazosini mesilas..........................................................5.5-4222Doxazosin mesilate ...........................................................5.5-4222Doxepin hydrochloride ........................................................... 1480Doxepini hydrochloridum .................................................... 1480Doxorubicin hydrochloride.................................................... 1481Doxorubicini hydrochloridum............................................. 1481Doxycycline hyclate ................................................................. 1482Doxycycline monohydrate...................................................... 1484Doxycyclini hyclas .................................................................. 1482Doxycyclinum monohydricum ............................................ 1484Doxylamine hydrogen succinate........................................... 1486Doxylamini hydrogenosuccinas ......................................... 1486Droperidol.................................................................................. 1487Droperidolum........................................................................... 1487Droppers (2.1.1.)............................................................................17Drop point (2.2.17.)...................................................................... 33Drops (nasal) and sprays (liquid nasal) ........................5.6-4473Drops, oral ..........................................................................5.6-4472Dry extracts ........................................................................5.8-5222Dry residue of extracts (2.8.16.).............................................. 222Duck plague vaccine (live) ..............................................5.3-3419Duck viral hepatitis type I vaccine (live)............................... 751Dwarf pine oil ....................................................................5.8-5304

EEar drops and ear sprays.................................................5.5-4157Ear powders .......................................................................5.5-4157Ear preparations................................................................5.5-4156Ear preparations, semi-solid ...........................................5.5-4157Ear sprays and ear drops.................................................5.5-4157Ear tampons.......................................................................5.5-4157Ear washes..........................................................................5.5-4157Ebastine ..................................................................................... 1491Ebastinum ................................................................................. 1491Echinaceae angustifoliae radix....................................5.7-5064Echinaceae pallidae radix .............................................5.7-5085Echinaceae purpureae herba........................................5.7-5098Echinaceae purpureae radix.........................................5.7-5100Econazole .................................................................................. 1492Econazole nitrate ..................................................................... 1493Econazoli nitras ...................................................................... 1493Econazolum.............................................................................. 1492Edetic acid ..........................................................................5.4-3933Edrophonii chloridum ........................................................... 1495Edrophonium chloride............................................................ 1495Effervescent granules....................................................... 5.2-3141Effervescent powders .......................................................5.2-3148Effervescent tablets ..........................................................5.8-5240Efficacy of antimicrobial preservation (5.1.3.) ..................... 447Egg drop syndrome ’76 vaccine (inactivated)...................... 753



Elder flower............................................................................... 1496Electrophoresis (2.2.31.) ............................................................. 45Electrophoresis, capillary (2.2.47.) ............................................74Eleutherococci radix .......................................................5.3-3491Eleutherococcus................................................................5.3-3491Emedastine difumarate....................................................5.4-3934Emedastini difumaras.....................................................5.4-3934Emetine hydrochloride heptahydrate.................................. 1499Emetine hydrochloride pentahydrate..................................1500Emetini hydrochloridum heptahydricum......................... 1499Emetini hydrochloridum pentahydricum ........................1500Emplastra transcutanea .................................................5.2-3146Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components (3.2.4.) ..............311

Emulsifying cetostearyl alcohol (type A) .....................5.6-4545Emulsifying cetostearyl alcohol (type B).....................5.6-4546Emulsions, solutions and suspensions, oral ...............5.6-4471Enalaprilat dihydrate .......................................................5.8-5309Enalaprilatum dihydricum............................................5.8-5309Enalaprili maleas.............................................................5.1-2919Enalapril maleate ..............................................................5.1-2919Encephalitis vaccine (inactivated), tick-borne ............5.3-3414Endotoxins, bacterial (2.6.14.)..................................................161Enilconazole for veterinary use............................................1503Enilconazolum ad usum veterinarium .............................1503Enoxaparin sodium...........................................................5.8-5310Enoxaparinum natricum ...............................................5.8-5310Enoxolone..................................................................................1505Enoxolonum .............................................................................1505Ephedrine, anhydrous.............................................................1506Ephedrine hemihydrate ..........................................................1507Ephedrine hydrochloride ................................................5.4-3935Ephedrine hydrochloride, racemic.......................................1509Ephedrini hydrochloridum ...........................................5.4-3935Ephedrini racemici hydrochloridum .................................1509Ephedrinum anhydricum .....................................................1506Ephedrinum hemihydricum ................................................1507Epirubicin hydrochloride ................................................5.6-4572Epirubicini hydrochloridum .........................................5.6-4572Equine herpesvirus vaccine (inactivated) ............................. 754Equine influenza vaccine (inactivated) ................................. 755Equiseti herba .......................................................................... 1511Equisetum stem........................................................................ 1511Ergocalciferol............................................................................ 1512Ergocalciferolum ..................................................................... 1512Ergometrine maleate............................................................... 1514Ergometrini maleas ................................................................ 1514Ergotamine tartrate................................................................. 1515Ergotamini tartras .................................................................. 1515Erysipelas vaccine (inactivated), swine ................................. 793Erythritol ................................................................................... 1516Erythritolum............................................................................. 1516Erythromycin ............................................................................ 1518Erythromycin estolate......................................................5.4-3936Erythromycin ethylsuccinate................................................. 1521Erythromycini estolas.....................................................5.4-3936Erythromycini ethylsuccinas ............................................... 1521Erythromycini lactobionas ............................................5.7-5005Erythromycini stearas ...........................................................1526Erythromycin lactobionate .............................................5.7-5005Erythromycin stearate ............................................................1526Erythromycinum ..................................................................... 1518Erythropoietin concentrated solution..........................5.3-3494Erythropoietini solutio concentrata............................5.3-3494Eserine salicylate .....................................................................2239Eserine sulphate.......................................................................2240Eserini salicylas ......................................................................2239Eserini sulfas............................................................................2240Esketamine hydrochloride .....................................................1533

Esketamini hydrochloridum ................................................1533Essential oils ......................................................................5.8-5218Essential oils, assay of 1,8-cineole (2.8.11.) ...........................216Essential oils, fatty oils and resinified essential oils in(2.8.7.)..........................................................................................216

Essential oils, foreign esters in (2.8.6.) ..................................216Essential oils in vegetable drugs, determination of(2.8.12.) .......................................................................................217

Essential oils, odour and taste (2.8.8.) ...................................216Essential oils, residue on evaporation (2.8.9.) ......................216Essential oils, solubility in alcohol (2.8.10.)..........................216Essential oils, water in (2.8.5.) .................................................216Ester value (2.5.2.) ..................................................................... 127Estradiol benzoate...................................................................1534Estradiol hemihydrate.............................................................1535Estradioli benzoas...................................................................1534Estradioli valeras.....................................................................1536Estradiolum hemihydricum .................................................1535Estradiol valerate .....................................................................1536Estriol .........................................................................................1537Estriolum ...................................................................................1537Estrogeni coniuncti ................................................................1539Estrogens, conjugated ............................................................1539Etacrynic acid ...........................................................................1542Etamsylate .................................................................................1542Etamsylatum ............................................................................1542Ethacridine lactate monohydrate.........................................1543Ethacridini lactas monohydricus .......................................1543Ethambutol hydrochloride.....................................................1544Ethambutoli hydrochloridum ..............................................1544Ethanol (96 per cent) ..............................................................1545Ethanol, anhydrous .................................................................1547Ethanol content and alcoholimetric tables (2.9.10.) .......... 237Ethanolum (96 per centum) .................................................1545Ethanolum anhydricum ........................................................1547Ether ...........................................................................................1548Ether, anaesthetic ....................................................................1549Ethinylestradiol ........................................................................1550Ethinylestradiolum .................................................................1550Ethionamide.............................................................................. 1551Ethionamidum ......................................................................... 1551Ethosuximide .....................................................................5.3-3498Ethosuximidum ................................................................5.3-3498Ethoxylated substances, ethylene glycol and diethyleneglycol in (2.4.30.) ............................................................5.2-3095

Ethyl acetate .............................................................................1553Ethyl acrylate - methacrylic acid copolymer (1:1) .....5.7-5050Ethylcellulose ...........................................................................1555Ethylcellulosum .......................................................................1555Ethylendiaminum ...................................................................1556Ethylenediamine ......................................................................1556Ethylene glycol and diethylene glycol in ethoxylatedsubstances (2.4.30.)........................................................5.2-3095

Ethylene glycol monopalmitostearate.................................1556Ethylene glycol monostearate...............................................1556Ethylene oxide and dioxan (2.4.25.) .......................................118Ethylenglycoli monopalmitostearas...................................1556Ethylhexanoic acid, 2- (2.4.28.) ............................................... 120Ethylis acetas ...........................................................................1553Ethylis oleas..............................................................................1553Ethylis parahydroxybenzoas ................................................1554Ethylis parahydroxybenzoas natricus ........................5.7-5007Ethylmorphine hydrochloride...............................................1557Ethylmorphini hydrochloridum ..........................................1557Ethyl oleate ...............................................................................1553Ethyl parahydroxybenzoate...................................................1554Ethyl parahydroxybenzoate sodium .............................5.7-5007Etidronate disodium.........................................................5.5-4227Etilefrine hydrochloride .........................................................1558



Etilefrini hydrochloridum.....................................................1558Etodolac .....................................................................................1560Etodolacum...............................................................................1560Etofenamate .............................................................................. 1561Etofenamatum ......................................................................... 1561Etofylline....................................................................................1563Etofyllinum ...............................................................................1563Etomidate ..................................................................................1564Etomidatum ..............................................................................1564Etoposide ...................................................................................1565Etoposidum...............................................................................1565Eucalypti aetheroleum ...................................................5.2-3203Eucalypti folium ......................................................................1569Eucalyptus leaf .........................................................................1569Eucalyptus oil ....................................................................5.2-3203Eugenol ...................................................................................... 1571Eugenolum................................................................................ 1571European Goldenrod........................................................5.3-3507European viper venom antiserum.......................................... 806Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)................................................................................5.1-2829

Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) .......................................................5.1-2830

Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ...............................................................................5.1-2827

Evening primrose oil, refined.........................................5.5-4227Extracta...............................................................................5.8-5220Extractable volume of parenteral preparations, test for(2.9.17.)..............................................................................5.3-3363

Extracta fluida ..................................................................5.8-5221Extracta sicca ....................................................................5.8-5222Extracta spissa ..................................................................5.8-5222Extracts ...............................................................................5.8-5220Extracts, dry .......................................................................5.8-5222Extracts, dry residue of (2.8.16.)............................................. 222Extracts, liquid...................................................................5.8-5221Extracts, loss on drying of (2.8.17.)........................................ 222Extracts, soft ......................................................................5.8-5222Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 169

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)................................5.3-3345

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .............................................................................5.4-3699

Eye drops ............................................................................5.5-4158Eye lotions ..........................................................................5.5-4158Eye preparations ...............................................................5.5-4157Eye preparations, semi-solid ...........................................5.5-4159

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .....................................................5.1-2821

Factor humanus von Willebrandi ................................5.6-4606Factor II, human coagulation, assay of (2.7.18.) ................. 209Factor IX coagulationis humanus ...................................... 1738Factor IX, human coagulation .............................................. 1738Factor IX, human coagulation, assay of (2.7.11.) .......5.5-4120Factor VII coagulationis humanus .................................... 1734Factor VII, human coagulation............................................. 1734Factor VII, human coagulation, assay of (2.7.10.) .....5.6-4419Factor VIII coagulationis humanus............................5.6-4596Factor VIII coagulationis humanus (ADNr) .................... 1737Factor VIII, human coagulation ....................................5.6-4596Factor VIII, human coagulation, assay of (2.7.4.) ......5.5-4119Factor VIII (rDNA), human coagulation ............................. 1737Factor X, human coagulation, assay of (2.7.19.) ..................210Factor XI coagulationis humanus ...............................5.5-4246Factor XI, human coagulation .......................................5.5-4246Factor XI, human coagulation, assay of (2.7.22.).......5.5-4121

Fagopyri herba .................................................................5.8-5278Falling ball viscometer method (2.2.49.) ................................ 80Famotidine.................................................................................1575Famotidinum............................................................................1575Fatty acids, composition by gas chromatography(2.4.22.) .............................................................................5.6-4389

Fatty oils, alkaline impurities in (2.4.19.) ............................. 109Fatty oils and herbal drugs, heavy metals in (2.4.27.) ........119Fatty oils and resinified essential oils in essential oils(2.8.7.)..........................................................................................216

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) ...................................................................................... 109

Fatty oils, identification by thin-layer chromatography(2.3.2.) .......................................................................................... 98

Fatty oils, sterols in (2.4.23.) ..........................................5.1-2787Fatty oils, vegetable..........................................................5.8-5233Fc function of immunoglobulin, test for (2.7.9.) ................. 202Febantel for veterinary use.............................................5.8-5315Febantelum ad usum veterinarium.............................5.8-5315Feline calicivirosis vaccine (inactivated) ............................... 757Feline calicivirosis vaccine (live), freeze-dried ..................... 758Feline chlamydiosis vaccine (inactivated)....................5.6-4489Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 759

Feline infectious enteritis (feline panleucopenia) vaccine(live) ............................................................................................ 760

Feline leukaemia vaccine (inactivated)...................................761Feline panleucopenia vaccine (inactivated).......................... 759Feline panleucopenia vaccine (live) ....................................... 760Feline viral rhinotracheitis vaccine (inactivated) .......5.7-4951Feline viral rhinotracheitis vaccine (live).....................5.7-4952Felodipine .................................................................................. 1576Felodipinum ............................................................................. 1576Felypressin..........................................................................5.2-3207Felypressinum...................................................................5.2-3207Fenbendazole for veterinary use ..........................................1577Fenbendazolum ad usum veterinarium............................1577Fenbufen ....................................................................................1578Fenbufenum..............................................................................1578Fennel, bitter.............................................................................1580Fennel, sweet.............................................................................1580Fenofibrate .........................................................................5.6-4577Fenofibratum.....................................................................5.6-4577Fenoterol hydrobromide.........................................................1583Fenoteroli hydrobromidum ..................................................1583Fentanyl .....................................................................................1584Fentanyl citrate.........................................................................1585Fentanyli citras ........................................................................1585Fentanylum...............................................................................1584Fenticonazole nitrate ..............................................................1586Fenticonazoli nitras ...............................................................1586Fenugreek..................................................................................1588Fermentation, products of ....................................................... 576Ferric chloride hexahydrate ..................................................1588Ferri chloridum hexahydricum...........................................1588Ferrosi fumaras .......................................................................1589Ferrosi gluconas ......................................................................1590Ferrosi sulfas desiccatus ................................................5.7-5011Ferrosi sulfas heptahydricus ................................................ 1591Ferrous fumarate .....................................................................1589Ferrous gluconate....................................................................1590Ferrous sulphate, dried....................................................5.7-5011Ferrous sulphate heptahydrate............................................. 1591Ferrum ad praeparationes homoeopathicas ..................... 899Feverfew .....................................................................................1592Fibrini glutinum......................................................................1593Fibrinogen, human ...........................................................5.6-4597Fibrinogenum humanum ..............................................5.6-4597Fibrin sealant kit ......................................................................1593



Fila non resorbilia sterilia .............................................5.3-3423Fila non resorbilia sterilia in fuso ad usumveterinarium ............................................................................ 888

Fila resorbilia synthetica monofilamenta sterilia ............ 880Fila resorbilia synthetica torta sterilia ................................ 878Filipendulae ulmariae herba ...............................................1980Filum bombycis tortum sterile in fuso ad usumveterinarium ............................................................................ 887

Filum ethyleni polyterephthalici sterile in fuso ad usumveterinarium ............................................................................ 887

Filum lini sterile in fuso ad usum veterinarium .............. 886Filum polyamidicum-6/6 sterile in fuso ad usumveterinarium ............................................................................ 887

Filum polyamidicum-6 sterile in fuso ad usumveterinarium ............................................................................ 886

Finasteride.................................................................................1594Finasteridum ............................................................................1594Fish oil, rich in omega-3-acids........................................5.4-3941Flecainide acetate ....................................................................1598Flecainidi acetas .....................................................................1598Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) ...................................5.6-4424

Flowability (2.9.16.) ................................................................... 242Flow cytometry (2.7.24.) ..................................................5.6-4423Flubendazole ............................................................................1599Flubendazolum ........................................................................1599Flucloxacillin sodium .......................................................5.6-4578Flucloxacillinum natricum............................................5.6-4578Fluconazole ........................................................................5.6-4580Fluconazolum ...................................................................5.6-4580Flucytosine ................................................................................ 1602Flucytosinum ........................................................................... 1602Fludarabine phosphate....................................................5.1-2926Fludarabini phosphas .....................................................5.1-2926Fludeoxyglucose (18F) injection .............................................. 822Fludeoxyglucosi (18F) solutio iniectabilis ........................... 822Fludrocortisone acetate.......................................................... 1603Fludrocortisoni acetas ........................................................... 1603Flumazenil ................................................................................. 1604Flumazenil (N-[11C]methyl) injection ..................................... 825Flumazenil (N-[11C]methyl) solutio iniectabilis................. 825Flumazenilum.......................................................................... 1604Flumequine ........................................................................5.6-4581Flumequinum....................................................................5.6-4581Flumetasone pivalate .............................................................. 1607Flumetasoni pivalas ............................................................... 1607Flunarizine dihydrochloride.................................................. 1608Flunarizini dihydrochloridum ............................................ 1608Flunitrazepam........................................................................... 1609Flunitrazepamum ................................................................... 1609Flunixini megluminum ad usum veterinarium.......5.1-2929Flunixin meglumine for veterinary use........................5.1-2929Fluocinolone acetonide .......................................................... 1610Fluocinoloni acetonidum ..................................................... 1610Fluocortolone pivalate............................................................ 1611Fluocortoloni pivalas ............................................................. 1611Fluorescein sodium ..........................................................5.2-3208Fluoresceinum natricum ...............................................5.2-3208Fluorides (2.4.5.) ........................................................................ 104Fluorimetry (2.2.21.) ................................................................... 35Fluorouracil............................................................................... 1614Fluorouracilum........................................................................ 1614Fluoxetine hydrochloride ................................................5.3-3503Fluoxetini hydrochloridum ...........................................5.3-3503Flupentixol dihydrochloride ...................................................1617Flupentixoli dihydrochloridum ............................................1617Fluphenazine decanoate ........................................................ 1619Fluphenazine dihydrochloride.......................................5.8-5316Fluphenazine enantate ........................................................... 1620

Fluphenazini decanoas ......................................................... 1619Fluphenazini dihydrochloridum .................................5.8-5316Fluphenazini enantas............................................................ 1620Flurazepami monohydrochloridum................................... 1622Flurazepam monohydrochloride .......................................... 1622Flurbiprofen .............................................................................. 1623Flurbiprofenum ....................................................................... 1623Fluspirilene ............................................................................... 1625Fluspirilenum .......................................................................... 1625Flutamide................................................................................... 1626Flutamidum .............................................................................. 1626Fluticasone propionate ........................................................... 1627Fluticasoni propionas ............................................................ 1627Flutrimazole .............................................................................. 1629Flutrimazolum ......................................................................... 1629Foams, cutaneous .............................................................5.5-4160Foams, intrauterine ..........................................................5.3-3397Foams, medicated ...................................................................... 604Foams, rectal ......................................................................5.5-4164Foams, vaginal ...................................................................5.5-4169Foeniculi amari fructus.........................................................1580Foeniculi amari fructus aetheroleum................................ 1108Foeniculi dulcis fructus.........................................................1580Folic acid.............................................................................5.6-4582Foot-and-mouth disease (ruminants) vaccine(inactivated) .....................................................................5.1-2860

Foreign esters in essential oils (2.8.6.) ...................................216Foreign matter (2.8.2.) .............................................................. 215Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) ...................................................................................... 109

Formaldehyde, free (2.4.18.) .................................................... 109Formaldehyde solution (35 per cent) .................................. 1632Formaldehydi solutio (35 per centum).............................. 1632Formoterol fumarate dihydrate .....................................5.5-4232Formoteroli fumaras dihydricus ..................................5.5-4232Foscarnet sodium hexahydrate............................................. 1634Foscarnetum natricum hexahydricum.............................. 1634Fosfomycin calcium ................................................................. 1636Fosfomycin sodium.................................................................. 1637Fosfomycin trometamol ...................................................5.4-3943Fosfomycinum calcicum ....................................................... 1636Fosfomycinum natricum....................................................... 1637Fosfomycinum trometamolum .....................................5.4-3943Fowl cholera vaccine (inactivated) ................................5.1-2861Fowl-pox vaccine (live) .............................................................. 766Framycetini sulfas .................................................................. 1639Framycetin sulphate................................................................ 1639Frangula bark ........................................................................... 1641Frangula bark dry extract, standardised ............................ 1642Frangulae cortex ..................................................................... 1641Frangulae corticis extractum siccum normatum ........... 1642Frankincense, Indian .......................................................5.7-5031Fraxini folium .......................................................................... 1026Free formaldehyde (2.4.18.) ..................................................... 109Freezing point (2.2.18.)............................................................... 34Friability of uncoated tablets (2.9.7.)............................5.2-3103Fructose .................................................................................... 1643Fructosum ................................................................................. 1643Fucus .......................................................................................... 1869Fucus vel Ascophyllum .......................................................... 1869Fumariae herba ................................................................5.6-4584Fumitory .............................................................................5.6-4584Functional groups and ions, identification reactions of(2.3.1.)................................................................................ 5.5-4101

Furosemide.........................................................................5.1-2930Furosemidum ....................................................................5.1-2930Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids ............................................................................ 767

Fusidic acid ............................................................................... 1645



GGalactose.................................................................................... 1649Galactosum ............................................................................... 1649Gallamine triethiodide ............................................................1649Gallamini triethiodidum .......................................................1649Gallii (67Ga) citratis solutio iniectabilis ............................... 826Gallium (67Ga) citrate injection ............................................... 826Gargles.................................................................................5.4-3845Garlic for homoeopathic preparations .................................. 897Garlic powder............................................................................ 1651Gas chromatography (2.2.28.) ................................................... 42Gas detector tubes (2.1.6.) ..........................................................19Gases, carbon dioxide in (2.5.24.)........................................... 134Gases, carbon monoxide in (2.5.25.) ...................................... 134Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) ...................................................................................... 135

Gases, nitrous oxide in (2.5.35.)...............................................141Gases, oxygen in (2.5.27.) ......................................................... 136Gases, water in (2.5.28.)............................................................ 136Gas-gangrene antitoxin, mixed ................................................ 802Gas-gangrene antitoxin (novyi) ............................................... 802Gas-gangrene antitoxin (perfringens) .................................... 803Gas-gangrene antitoxin (septicum)......................................... 804Gastro-resistant capsules .................................................5.5-4156Gastro-resistant granules................................................. 5.2-3141Gastro-resistant tablets ....................................................5.8-5240Gelatin ........................................................................................ 1651Gelatina ..................................................................................... 1651Gels.......................................................................................5.5-4165Gels for injections .............................................................5.2-3146Gemcitabine hydrochloride.............................................5.6-4589Gemcitabini hydrochloridum........................................5.6-4589Gemfibrozil .........................................................................5.5-4239Gemfibrozilum ..................................................................5.5-4239General notices (1.)...........................................................5.6-4373General texts on sterility (5.1.) ................................................ 445General texts on vaccines (5.2.) .............................................. 453Gene transfer medicinal products for human use(5.14.).................................................................................5.6-4461

Gentamicini sulfas .................................................................. 1653Gentamicin sulphate................................................................ 1653Gentianae radix ....................................................................... 1654Gentianae tinctura.................................................................. 1655Gentian root ..............................................................................1654Gentian tincture ....................................................................... 1655Ginger ......................................................................................... 1656Gingival solutions .............................................................5.4-3845Ginkgo folium .......................................................................... 1657Ginkgo leaf ................................................................................ 1657Ginseng................................................................................5.1-2935Ginseng radix ....................................................................5.1-2935Glass containers for pharmaceutical use (3.2.1.) ................ 303Glibenclamide ........................................................................... 1659Glibenclamidum ...................................................................... 1659Gliclazide.................................................................................... 1660Gliclazidum............................................................................... 1660Glimepiride .........................................................................5.4-3948Glimepiridum ....................................................................5.4-3948Glipizide ..............................................................................5.4-3950Glipizidum .........................................................................5.4-3950Glossary (dosage forms) ........................................................... 599Glucagon, human..................................................................... 1665Glucagonum humanum ........................................................ 1665Glucose, anhydrous ................................................................. 1666Glucose, liquid .......................................................................... 1667Glucose, liquid, spray-dried.................................................... 1668Glucose monohydrate ............................................................. 1669Glucosum anhydricum .......................................................... 1666Glucosum liquidum ................................................................ 1667

Glucosum liquidum dispersione desiccatum................... 1668Glucosum monohydricum .................................................... 1669Glutamic acid ............................................................................ 1670Glutathione.........................................................................5.7-5015Glutathionum ....................................................................5.7-5015Glycerol ...................................................................................... 1671Glycerol (85 per cent).............................................................. 1672Glycerol dibehenate ..........................................................5.1-2938Glycerol distearate ............................................................5.7-5016Glyceroli dibehenas .........................................................5.1-2938Glyceroli distearas ...........................................................5.7-5016Glyceroli monolinoleas ........................................................ 1675Glyceroli mono-oleas.......................................................5.6-4590Glyceroli monostearas 40-55.........................................5.7-5017Glyceroli trinitratis solutio ................................................... 1678Glycerol monolinoleate ........................................................... 1675Glycerol mono-oleate........................................................5.6-4590Glycerol monostearate 40-55..........................................5.7-5017Glycerol triacetate.................................................................... 2612Glycerolum................................................................................ 1671Glycerolum (85 per centum) ................................................ 1672Glyceryl trinitrate solution..................................................... 1678Glycine .................................................................................5.7-5018Glycinum ............................................................................5.7-5018Glycyrrhizate ammonium................................................5.1-2876Goldenrod ...........................................................................5.2-3213Goldenrod, European.......................................................5.3-3507Goldenseal rhizome................................................................. 1683Gonadorelin acetate ................................................................ 1684Gonadorelini acetas ............................................................... 1684Gonadotrophin, chorionic ......................................................1686Gonadotrophin, equine serum, for veterinary use............ 1686Gonadotropinum chorionicum ........................................... 1686Gonadotropinum sericum equinum ad usumveterinarium .......................................................................... 1686

Goserelin .................................................................................... 1687Goserelinum ............................................................................. 1687Gossypii oleum hydrogenatum............................................1370Gramicidin ................................................................................. 1689Gramicidinum .......................................................................... 1689Graminis rhizoma................................................................... 1371Granisetron hydrochloride..............................................5.1-2939Granisetroni hydrochloridum.......................................5.1-2939Granulata ...........................................................................5.2-3140Granules ..............................................................................5.2-3140Granules and powders for oral solutions andsuspensions......................................................................5.6-4472

Granules and powders for syrups..................................5.6-4472Granules, coated................................................................ 5.2-3141Granules, effervescent...................................................... 5.2-3141Granules, gastro-resistant................................................ 5.2-3141Granules, modified-release.............................................. 5.2-3141Greater celandine ..................................................................... 1690Griseofulvin ............................................................................... 1691Griseofulvinum ........................................................................ 1691Guaiacol ..............................................................................5.6-4591Guaiacolum .......................................................................5.6-4591Guaifenesin................................................................................ 1692Guaifenesinum ........................................................................ 1692Guanethidine monosulphate ................................................. 1694Guanethidini monosulfas ..................................................... 1694Guar ............................................................................................ 1694Guar galactomannan ............................................................... 1695Guar galactomannanum ....................................................... 1695

HHaematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.).........................................................................5.6-4421

Haematopoietic stem cells, human ...............................5.6-4598



Haemodiafiltration and for haemofiltration, solutionsfor .............................................................................................. 1703

Haemodialysis, concentrated solutions for ........................ 1700Haemodialysis solutions, concentrated, water fordiluting..................................................................................... 1699

Haemodialysis, solutions for.................................................. 1700Haemofiltration and for haemodiafiltration, solutionsfor .............................................................................................. 1703

Haemophilus type b (conjugate), diphtheria, tetanusand pertussis (acellular, component) vaccine(adsorbed).........................................................................5.4-3852

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ..................................5.4-3861

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component), hepatitis B (rDNA) andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3858

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).........................................................................5.4-3866

Haemophilus type b conjugate vaccine................................. 662Halofantrine hydrochloride ................................................... 1705Halofantrini hydrochloridum .............................................. 1705Haloperidol................................................................................ 1706Haloperidol decanoate............................................................ 1708Haloperidoli decanoas........................................................... 1708Haloperidolum ......................................................................... 1706Halothane .................................................................................. 1709Halothanum.............................................................................. 1709Hamamelidis folium ............................................................... 1711Hamamelis leaf ......................................................................... 1711Hard capsules.....................................................................5.5-4155Hard fat ...................................................................................... 1711Hard paraffin............................................................................. 2186Harpagophyti radix ................................................................ 1401Hawthorn berries ..................................................................... 1712Hawthorn leaf and flower ...................................................... 1713Hawthorn leaf and flower dry extract ................................. 1714Hawthorn leaf and flower liquid extract, quantified ..5.3-3511Heavy bismuth subnitrate ...................................................... 1107Heavy kaolin..............................................................................1869Heavy magnesium carbonate .........................................5.3-3547Heavy magnesium oxide..................................................5.6-4629Heavy metals (2.4.8.) ................................................................. 104Heavy metals in herbal drugs and fatty oils (2.4.27.)..........119Hederae folium .................................................................5.6-4613Hedera helix ad praeparationes homoeopathicas...5.2-3163Hedera helix for homoeopathic preparations.............5.2-3163Helianthi annui oleum raffinatum..................................... 2524Helium .................................................................................5.7-5023Helium ................................................................................ 5.7-502 3Heparina massae molecularis minoris ..............................1717Heparin, assay of (2.7.5.) .................................................5.6-4419Heparin calcium ................................................................5.5-4245Heparin in coagulation factors, assay of (2.7.12.)............... 204Heparins, low-molecular-mass ................................................1717Heparin sodium.................................................................5.5-4245Heparinum calcicum ......................................................5.5-4245Heparinum natricum ......................................................5.5-4245Hepatitis A immunoglobulin, human ...................................1741Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 664

Hepatitis A vaccine, assay of (2.7.14.) ...........................5.1-2795Hepatitis A vaccine (inactivated, adsorbed) ......................... 665Hepatitis A vaccine (inactivated, virosome) ......................... 667Hepatitis B immunoglobulin for intravenous administration,human .......................................................................................1741

Hepatitis B immunoglobulin, human ...................................1741

Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 641

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ...............5.4-3854

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858

Hepatitis B vaccine (rDNA)...................................................... 670Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 207Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines..............................................5.5-4113

Heptaminol hydrochloride ..................................................... 1719Heptaminoli hydrochloridum .............................................. 1719Herbal drug preparations......................................................... 572Herbal drugs ............................................................................... 572Herbal drugs and fatty oils, heavy metals in (2.4.27.).........119Herbal drugs, determination of aflatoxin B1 in(2.8.18.) .............................................................................5.7-4801

Herbal drugs, determination of tannins (2.8.14.) ............... 221Herbal drugs for homoeopathic preparations ............5.2-3161Herbal teas................................................................................... 573Hexamidine diisetionate ..................................................5.2-3217Hexamidini diisetionas ..................................................5.2-3217Hexetidine.................................................................................. 1721Hexetidinum ............................................................................. 1721Hexobarbital.............................................................................. 1722Hexobarbitalum ....................................................................... 1722Hexosamines in polysaccharide vaccines (2.5.20.) ............. 132Hexylresorcinol......................................................................... 1723Hexylresorcinolum ................................................................. 1723Hibisci sabdariffae flos ..........................................................2376Highly purified water ..............................................................2695Histamine (2.6.10.)..................................................................... 153Histamine dihydrochloride .................................................... 1724Histamine phosphate .............................................................. 1725Histamini dihydrochloridum ............................................... 1724Histamini phosphas................................................................ 1725Histidine..............................................................................5.1-2945Histidine hydrochloride monohydrate ................................ 1727Histidini hydrochloridum monohydricum....................... 1727Histidinum .........................................................................5.1-2945Homatropine hydrobromide .................................................. 1728Homatropine methylbromide ................................................ 1729Homatropini hydrobromidum ............................................. 1728Homatropini methylbromidum ........................................... 1729Homoeopathic preparations ...........................................5.8-5259Homoeopathic preparations, arsenious trioxide for .......... 895Homoeopathic preparations, calcium iodide tetrahydratefor .......................................................................................5.2-3162

Homoeopathic preparations, common stinging nettlefor .......................................................................................5.3-3429

Homoeopathic preparations, copper acetate monohydratefor .......................................................................................5.2-3162

Homoeopathic preparations, copper for............................... 896Homoeopathic preparations, garlic for ................................. 897Homoeopathic preparations, hedera helix for............5.2-3163Homoeopathic preparations, herbal drugs for ........... 5.2-3161Homoeopathic preparations, honey bee for......................... 898Homoeopathic preparations, hyoscyamus for ............5.2-3164Homoeopathic preparations, hypericum for ........................ 898Homoeopathic preparations, iron for .................................... 899Homoeopathic preparations, mother tinctures for............. 894Homoeopathic preparations, oriental cashew for......5.3-3430Homoeopathic preparations, saffron for............................... 900Homoeopathic stocks (methods of preparation of) andpotentisation....................................................................5.8-5260

Honey ..................................................................................5.1-2946Honey bee for homoeopathic preparations.......................... 898



Hop strobile............................................................................... 1730Human albumin injection, iodinated (125I)............................ 827Human albumin solution ................................................5.3-3511Human anti-D immunoglobulin .....................................5.6-4595Human anti-D immunoglobulin, assay of (2.7.13.).............. 205Human anti-D immunoglobulin for intravenousadministration .................................................................5.6-4595

Human antithrombin III, assay of (2.7.17.) ........................... 209Human antithrombin III concentrate .................................. 1733Human coagulation factor II, assay of (2.7.18.)................... 209Human coagulation factor IX................................................ 1738Human coagulation factor IX, assay of (2.7.11.).........5.5-4120Human coagulation factor VII .............................................. 1734Human coagulation factor VII, assay of (2.7.10.) .......5.6-4419Human coagulation factor VIII......................................5.6-4596Human coagulation factor VIII, assay of (2.7.4.)........5.5-4119Human coagulation factor VIII (rDNA)............................... 1737Human coagulation factor X, assay of (2.7.19.) ....................210Human coagulation factor XI.........................................5.5-4246Human coagulation factor XI, assay of (2.7.22.) ........5.5-4121Human fibrinogen.............................................................5.6-4597Human haematopoietic stem cells ................................5.6-4598Human hepatitis A immunoglobulin ....................................1741Human hepatitis B immunoglobulin ....................................1741Human hepatitis B immunoglobulin for intravenousadministration .........................................................................1741

Human insulin ..........................................................................1800Human measles immunoglobulin......................................... 1742Human normal immunoglobulin...................................5.6-4599Human normal immunoglobulin for intravenousadministration .................................................................5.6-4601

Human plasma for fractionation....................................5.6-4603Human plasma (pooled and treated for virusinactivation) .....................................................................5.6-4604

Human prothrombin complex............................................... 1748Human rabies immunoglobulin............................................ 1750Human rubella immunoglobulin .......................................... 1751Human tetanus immunoglobulin ......................................... 1751Human varicella immunoglobulin........................................ 1752Human varicella immunoglobulin for intravenousadministration ........................................................................ 1753

Human von Willebrand factor........................................5.6-4606Human von Willebrand factor, assay of (2.7.21.) .......5.5-4120Hyaluronidase .......................................................................... 1753Hyaluronidasum ..................................................................... 1753Hydralazine hydrochloride .................................................... 1754Hydralazini hydrochloridum ............................................... 1754Hydrargyri dichloridum ........................................................1995Hydrastis rhizoma .................................................................. 1683Hydrochloric acid, concentrated........................................... 1755Hydrochloric acid, dilute ........................................................ 1756Hydrochlorothiazide................................................................ 1756Hydrochlorothiazidum .......................................................... 1756Hydrocodone hydrogen tartrate 2.5-hydrate ..............5.7-5023Hydrocodoni hydrogenotartras 2.5-hydricus ...........5.7-5023Hydrocortisone......................................................................... 1757Hydrocortisone acetate........................................................... 1759Hydrocortisone hydrogen succinate .....................................1761Hydrocortisoni acetas ............................................................ 1759Hydrocortisoni hydrogenosuccinas ....................................1761Hydrocortisonum .................................................................... 1757Hydrogenated arachis oil ....................................................... 1018Hydrogenated castor oil ..................................................5.8-5289Hydrogenated cottonseed oil ................................................1370Hydrogenated soya-bean oil...................................................2475Hydrogenated vegetable oils, nickel in (2.4.31.).........5.7-4781Hydrogenated wool fat............................................................2708Hydrogenii peroxidum 30 per centum.............................. 1763Hydrogenii peroxidum 3 per centum ................................ 1762

Hydrogen peroxide solution (30 per cent) ......................... 1763Hydrogen peroxide solution (3 per cent)............................ 1762Hydromorphone hydrochloride ............................................ 1763Hydromorphoni hydrochloridum ....................................... 1763Hydrophobic colloidal anhydrous silica.......................5.8-5362Hydrous wool fat ......................................................................2709Hydroxocobalamin acetate..............................................5.6-4607Hydroxocobalamin chloride............................................5.6-4608Hydroxocobalamini acetas ............................................5.6-4607Hydroxocobalamini chloridum ....................................5.6-4608Hydroxocobalamini sulfas .............................................5.6-4609Hydroxocobalamin sulphate ...........................................5.6-4609Hydroxycarbamide ................................................................... 1768Hydroxycarbamidum ............................................................. 1768Hydroxyethylcellulose......................................................5.1-2947Hydroxyethylcellulosum.................................................5.1-2947Hydroxyethylis salicylas........................................................ 1769Hydroxyethylmethylcellulose ................................................ 2018Hydroxyethyl salicylate........................................................... 1769Hydroxyl value (2.5.3.) .............................................................. 127Hydroxypropylbetadex............................................................ 1771Hydroxypropylbetadexum .................................................... 1771Hydroxypropylcellulose .......................................................... 1773Hydroxypropylcellulosum .................................................... 1773Hydroxypropylmethylcellulose.......................................5.7-5025Hydroxypropylmethylcellulose phthalate ....................5.8-5321Hydroxyzine hydrochloride ................................................... 1774Hydroxyzini hydrochloridum .............................................. 1774Hymecromone........................................................................... 1775Hymecromonum...................................................................... 1775Hyoscine..............................................................................5.3-3519Hyoscine butylbromide ........................................................... 1776Hyoscine hydrobromide.......................................................... 1777Hyoscini butylbromidum ...................................................... 1776Hyoscini hydrobromidum..................................................... 1777Hyoscinum .........................................................................5.3-3519Hyoscyamine sulphate .....................................................5.3-3520Hyoscyamini sulfas .........................................................5.3-3520Hyoscyamus for homoeopathic preparations .............5.2-3164Hyoscyamus niger ad praeparationes homoeopathicas ..5.2-3164

Hyperici herba .........................................................................2485Hypericum .................................................................................2485Hypericum for homoeopathic preparations ......................... 898Hypericum perforatumad praeparationes homoeopathicas................................... 898

Hypromellose .....................................................................5.7-5025Hypromellose phthalate ..................................................5.8-5321Hypromellosi phthalas....................................................5.8-5321Hypromellosum ................................................................5.7-5025

IIbuprofen ................................................................................... 1785Ibuprofenum............................................................................. 1785Iceland moss.......................................................................5.3-3525ICH (5.8.)...................................................................................... 551Ichthammol ............................................................................... 1787Ichthammolum ........................................................................ 1787Identification (2.3.) ...................................................................... 95Identification and control of residual solvents (2.4.24.).... 113Identification of fatty oils by thin-layer chromatography(2.3.2.) .......................................................................................... 98

Identification of phenothiazines by thin-layerchromatography (2.3.3.) ........................................................... 99

Identification reactions of ions and functional groups(2.3.1.)................................................................................ 5.5-4101

Idoxuridine ................................................................................ 1788Idoxuridinum ........................................................................... 1788Iecoris aselli oleum A.............................................................1348



Iecoris aselli oleum B ............................................................1352Ifosfamide .................................................................................. 1789Ifosfamidum ............................................................................. 1789Imipenem ................................................................................... 1791Imipenemum ............................................................................ 1791Imipramine hydrochloride ..................................................... 1792Imipramini hydrochloridum................................................ 1792Immunochemical methods (2.7.1.) ......................................... 187Immunoglobulin for human use, anti-T lymphocyte,animal................................................................................5.6-4506

Immunoglobulin for intravenous administration, humanhepatitis B ................................................................................1741

Immunoglobulin for intravenous administration, humannormal ...............................................................................5.6-4601

Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 1753

Immunoglobulin, human anti-D ....................................5.6-4595Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 205Immunoglobulin, human anti-D, for intravenousadministration .................................................................5.6-4595

Immunoglobulin, human hepatitis A....................................1741Immunoglobulin, human hepatitis B ...................................1741Immunoglobulin, human measles ........................................ 1742Immunoglobulin, human normal ..................................5.6-4599Immunoglobulin, human rabies ........................................... 1750Immunoglobulin, human rubella ......................................... 1751Immunoglobulin, human tetanus......................................... 1751Immunoglobulin, human varicella ....................................... 1752Immunoglobulin, test for anticomplementary activity of(2.6.17.)....................................................................................... 170

Immunoglobulin, test for Fc function of (2.7.9.)................. 202Immunoglobulinum anti-T lymphocytorum ex animale adusum humanum .............................................................5.6-4506

Immunoglobulinum humanum anti-D.......................5.6-4595Immunoglobulinum humanum anti-D ad usumintravenosum ..................................................................5.6-4595

Immunoglobulinum humanum hepatitidis A ..................1741Immunoglobulinum humanum hepatitidis B ..................1741Immunoglobulinum humanum hepatitidis B ad usumintravenosum ..........................................................................1741

Immunoglobulinum humanum morbillicum .................. 1742Immunoglobulinum humanum normale ..................5.6-4599Immunoglobulinum humanum normale ad usumintravenosum ..................................................................5.6-4601

Immunoglobulinum humanum rabicum.......................... 1750Immunoglobulinum humanum rubellae .......................... 1751Immunoglobulinum humanum tetanicum ...................... 1751Immunoglobulinum humanum varicellae ....................... 1752Immunoglobulinum humanum varicellae ad usumintravenosum ......................................................................... 1753

Immunosera ad usum veterinarium ...........................5.4-3835Immunosera and vaccines, phenol in (2.5.15.) .....................131Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827

Immunosera and vaccines, veterinary, evaluation of theefficacy (5.2.7) .................................................................5.1-2829

Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830

Immunosera ex animale ad usum humanum ..........5.8-5222Immunosera for human use, animal.............................5.8-5222Immunosera for veterinary use......................................5.4-3835Immunoserum botulinicum ................................................... 801Immunoserum clostridii novyi alpha ad usumveterinarium ...................................................................5.1-2865

Immunoserum clostridii perfringentis beta ad usumveterinarium ...................................................................5.1-2866

Immunoserum clostridii perfringentis epsilon ad usumveterinarium ...................................................................5.1-2867

Immunoserum contra venena viperarumeuropaearum ........................................................................... 806

Immunoserum diphthericum ................................................ 801Immunoserum gangraenicum (Clostridium novyi) ........ 802Immunoserum gangraenicum(Clostridium perfringens)..................................................... 803

Immunoserum gangraenicum (Clostridium septicum) .. 804Immunoserum gangraenicum mixtum ............................... 802Immunoserum tetanicum ad usum humanum................. 805Immunoserum tetanicum ad usum veterinarium...5.1-2868Implants ..............................................................................5.2-3146Impurities in substances for pharmaceutical use, control of(5.10.).................................................................................5.5-4145

Indapamide.........................................................................5.3-3525Indapamidum ...................................................................5.3-3525Indian frankincense..........................................................5.7-5031Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 27

Indii (111In) chloridi solutio .................................................... 828Indii (111In) oxini solutio ......................................................... 829Indii (111In) pentetatis solutio iniectabilis .......................... 830Indium (111In) chloride solution .............................................. 828Indium (111In) oxine solution ................................................... 829Indium (111In) pentetate injection........................................... 830Indometacin .............................................................................. 1794Indometacinum ....................................................................... 1794Infectious bovine rhinotracheitis vaccine (live),freeze-dried................................................................................ 768

Infectious bronchitis vaccine (inactivated), avian ......5.4-3881Infectious bronchitis vaccine (live), avian............................. 720Infectious bursal disease vaccine (inactivated), avian........ 722Infectious bursal disease vaccine (live), avian ..................... 723Infectious chicken anaemia vaccine (live) ............................ 769Infectious encephalomyelitis vaccine (live), avian .............. 725Infectious laryngotracheitis vaccine (live), avian ................ 727Influenza vaccine (split virion, inactivated) ................5.3-3401Influenza vaccine (surface antigen, inactivated)........5.3-3402Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ....................................................................5.5-4173

Influenza vaccine (surface antigen, inactivated,virosome) ..........................................................................5.3-3404

Influenza vaccine (whole virion, inactivated) .............5.3-3406Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ............................................................................5.5-4175

Infrared absorption spectrophotometry (2.2.24.) ................. 37Infusions .............................................................................5.2-3145Inhalanda...........................................................................5.1-2843Inhalation gas, krypton (81MKr) ............................................... 833Inhalation, preparations for............................................5.1-2843Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103

Injectable insulin preparations ......................................5.4-3957Injections ............................................................................5.2-3145Injections, gels for.............................................................5.2-3146Injections or infusions, concentrates for .....................5.2-3145Injections or infusions, powders for .............................5.2-3145Inositol, myo- .....................................................................5.8-5325Inserts, ophthalmic...........................................................5.5-4159Insulin aspart ............................................................................ 1795Insulin, bovine ...................................................................5.4-3955Insulin, human.......................................................................... 1800Insulini biphasici iniectabilium.......................................... 1802Insulini isophani biphasici iniectabilium ........................ 1803Insulini isophani iniectabilium .......................................... 1803Insulin injection, biphasic ...................................................... 1802Insulin injection, biphasic isophane .................................... 1803Insulin injection, isophane..................................................... 1803Insulin injection, soluble ........................................................1803Insulini solubilis iniectabilium ........................................... 1803



Insulini zinci amorphi suspensio iniectabilis................. 1811Insulini zinci cristallini suspensio iniectabilis............... 1812Insulini zinci suspensio iniectabilis .................................. 1811Insulin lispro .............................................................................1804Insulin, porcine.........................................................................1806Insulin preparations, injectable .....................................5.4-3957Insulinum aspartum .............................................................. 1795Insulinum bovinum .........................................................5.4-3955Insulinum humanum.............................................................1800Insulinum lisprum..................................................................1804Insulinum porcinum ..............................................................1806Insulin zinc injectable suspension ....................................... 1811Insulin zinc injectable suspension (amorphous) .............. 1811Insulin zinc injectable suspension (crystalline) ................ 1812Interferon alfa-2 concentrated solution .......................5.7-5032Interferon gamma-1b concentrated solution ..................... 1815Interferoni alfa-2 solutio concentrata.........................5.7-5032Interferoni gamma-1b solutio concentrata ...................... 1815Interferons, assay of (5.6.)...............................................5.3-3381International System (SI) units (1.) ..............................5.6-4373int-rac-α-Tocopherolum ..................................................5.6-4688int-rac-α-Tocopherylis acetas ........................................5.6-4691Intramammary preparations for veterinary use .................. 606Intraruminal devices ........................................................ 5.2-3141Intrauterine capsules .......................................................5.3-3397Intrauterine foams ............................................................5.3-3397Intrauterine preparations for veterinary use ..............5.3-3397Intrauterine solutions, suspensions..............................5.3-3397Intrauterine sticks.............................................................5.3-3397Intrauterine tablets...........................................................5.3-3397Intrinsic dissolution (2.9.29.) .........................................5.4-3705In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) .............................................................................5.6-4420

Iobenguane (123I) injection..............................................5.7-4957Iobenguane (131I) injection for diagnostic use ............5.7-4958Iobenguane (131I) injection for therapeutic use ..........5.7-4959Iobenguane sulphate for radiopharmaceuticalpreparations .....................................................................5.8-5255

Iobenguani (123I) solutio iniectabilis ...........................5.7-4957Iobenguani (131I) solutio iniectabilis ad usumdiagnosticum ..................................................................5.7-4958

Iobenguani (131I) solutio iniectabilis ad usumtherapeuticum.................................................................5.7-4959

Iobenguani sulfas ad radiopharmaceutica ...............5.8-5255Iodinated (125I) human albumin injection ............................. 827Iodinated povidone.................................................................. 2291Iodinati (125I) humani albumini solutio iniectabilis ........ 827Iodine.......................................................................................... 1819Iodine value (2.5.4.) ................................................................... 127Iodum ......................................................................................... 1819Iohexol........................................................................................ 1819Iohexolum ................................................................................. 1819Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 55

Ions and functional groups, identification reactions of(2.3.1.)................................................................................ 5.5-4101

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 55

Iopamidol ............................................................................5.2-3223Iopamidolum .....................................................................5.2-3223Iopanoic acid.............................................................................1824Iotalamic acid............................................................................1825Iotrolan................................................................................5.7-5035Iotrolanum .........................................................................5.7-5035Ioxaglic acid ..............................................................................1826Ipecacuanhae extractum fluidum normatum ..........5.1-2951Ipecacuanhae pulvis normatus ...........................................1829Ipecacuanhae radix ................................................................1829Ipecacuanhae tinctura normata ..................................5.1-2951

Ipecacuanha liquid extract, standardised ....................5.1-2951Ipecacuanha, prepared............................................................ 1829Ipecacuanha root ..................................................................... 1829Ipecacuanha tincture, standardised..............................5.1-2951Ipratropii bromidum .......................................................5.5-4253Ipratropium bromide........................................................5.5-4253Iron (2.4.9.) .................................................................................. 107Iron for homoeopathic preparations ..................................... 899Irrigation, preparations for .............................................5.6-4474Isoconazole................................................................................ 1833Isoconazole nitrate .................................................................. 1834Isoconazoli nitras ................................................................... 1834Isoconazolum........................................................................... 1833Isoelectric focusing (2.2.54.).......................................................81Isoflurane................................................................................... 1835Isofluranum .............................................................................. 1835Isoleucine................................................................................... 1836Isoleucinum .............................................................................. 1836Isomalt........................................................................................ 1837Isomaltum ................................................................................. 1837Isoniazid..................................................................................... 1839Isoniazidum ............................................................................. 1839Isophane insulin injection...................................................... 1803Isoprenaline hydrochloride.................................................... 1839Isoprenaline sulphate.............................................................. 1840Isoprenalini hydrochloridum .............................................. 1839Isoprenalini sulfas .................................................................. 1840Isopropyl alcohol...................................................................... 1841Isopropylis myristas ........................................................5.1-2952Isopropylis palmitas ........................................................5.1-2953Isopropyl myristate ...........................................................5.1-2952Isopropyl palmitate...........................................................5.1-2953Isosorbide dinitrate, diluted ................................................. 1844Isosorbide mononitrate, diluted .......................................... 1845Isosorbidi dinitras dilutus..................................................... 1844Isosorbidi mononitras dilutus ............................................. 1845Isotretinoin ................................................................................ 1847Isotretinoinum ......................................................................... 1847Isoxsuprine hydrochloride ..................................................... 1848Isoxsuprini hydrochloridum ................................................ 1848Ispaghula husk ..................................................................5.7-5037Ispaghula seed .......................................................................... 1850Isradipine ............................................................................5.3-3528Isradipinum .......................................................................5.3-3528Itraconazole .............................................................................. 1852Itraconazolum.......................................................................... 1852Iuniperi aetheroleum ............................................................. 1863Iuniperi pseudo-fructus ......................................................... 1862Ivermectin.................................................................................. 1854Ivermectinum ........................................................................... 1854Ivy leaf .................................................................................5.6-4613

JJavanese turmeric ....................................................................2645Java tea ................................................................................5.6-4617Josamycin................................................................................... 1860Josamycini propionas ............................................................ 1861Josamycin propionate.............................................................. 1861Josamycinum ........................................................................... 1860Juniper........................................................................................ 1862Juniper oil .................................................................................. 1863

KKalii acetas ...............................................................................2273Kalii bromidum........................................................................2273Kalii carbonas .......................................................................... 2274Kalii chloridum.................................................................5.2-3261Kalii citras .................................................................................2275



Kalii clavulanas ....................................................................... 2276Kalii clavulanas dilutus.........................................................2278Kalii dihydrogenophosphas .................................................2280Kalii hydrogenoaspartas hemihydricus ............................2280Kalii hydrogenocarbonas...................................................... 2281Kalii hydrogenotartras...........................................................2282Kalii hydroxidum ....................................................................2283Kalii iodidum ...........................................................................2283Kalii metabisulfis .............................................................5.3-3597Kalii natrii tartras tetrahydricus .........................................2286Kalii nitras ................................................................................2284Kalii perchloras .......................................................................2285Kalii permanganas .................................................................2286Kalii sorbas ...............................................................................2287Kalii sulfas ................................................................................2288Kanamycin acid sulphate .......................................................1867Kanamycini monosulfas .......................................................1868Kanamycini sulfas acidus .....................................................1867Kanamycin monosulphate......................................................1868Kaolin, heavy.............................................................................1869Kaolinum ponderosum..........................................................1869Kelp .............................................................................................1869Ketamine hydrochloride ..................................................5.4-3963Ketamini hydrochloridum .............................................5.4-3963Ketobemidone hydrochloride................................................ 1871Ketoconazole ............................................................................1872Ketoconazolum ........................................................................1872Ketoprofen................................................................................. 1874Ketoprofenum .......................................................................... 1874Ketorolac trometamol ......................................................5.5-4259Ketorolacum trometamolum .........................................5.5-4259Ketotifen hydrogen fumarate ................................................1875Ketotifeni hydrogenofumaras ..............................................1875Knotgrass...................................................................................1877Krypton (81mKr) inhalation gas................................................ 833Kryptonum (81mKr) ad inhalationem .................................. 833

LLabetalol hydrochloride ......................................................... 1881Labetaloli hydrochloridum................................................... 1881Lacca ..........................................................................................2409Lactic acid...........................................................................5.2-3227Lactic acid, (S)- ..................................................................5.2-3227Lactitol monohydrate..............................................................1883Lactitolum monohydricum...................................................1883Lactobionic acid .......................................................................1885Lactose, anhydrous...........................................................5.7-5041Lactose monohydrate.......................................................5.7-5042Lactosum anhydricum....................................................5.7-5041Lactosum monohydricum..............................................5.7-5042Lactulose....................................................................................1888Lactulose, liquid .......................................................................1890Lactulosum ...............................................................................1888Lactulosum liquidum .............................................................1890Lamivudine.........................................................................5.3-3537Lamivudinum ...................................................................5.3-3537Lanugo cellulosi absorbens.................................................. 2681Lanugo gossypii absorbens ..................................................1369Laser light diffraction, particle size analysis by(2.9.31.) ............................................................................5.6-4429

Lauroyl macrogolglycerides ...........................................5.5-4263Lavandulae aetheroleum ...............................................5.3-3539Lavandulae flos .......................................................................1893Lavender flower........................................................................1893Lavender oil........................................................................5.3-3539Lead in sugars (2.4.10.) ............................................................ 107Leflunomide .......................................................................5.7-5043Leflunomidum ..................................................................5.7-5043Lemon oil ...................................................................................1895

Lemon verbena leaf ..........................................................5.8-5329Leonuri cardiacae herba.......................................................2063Leptospirosis vaccine (inactivated), bovine.......................... 730Leptospirosis vaccine (inactivated), canine .......................... 740Letrozole .............................................................................5.6-4621Letrozolum.........................................................................5.6-4621Leucine....................................................................................... 1897Leucinum .................................................................................. 1897Leuprorelin.........................................................................5.4-3967Leuprorelinum..................................................................5.4-3967Levamisole for veterinary use ............................................... 1899Levamisole hydrochloride ......................................................1900Levamisoli hydrochloridum .................................................1900Levamisolum ad usum veterinarium ................................ 1899Levistici radix...........................................................................1932Levocabastine hydrochloride ................................................1902Levocabastini hydrochloridum ...........................................1902Levocarnitine .....................................................................5.1-2959Levocarnitinum ................................................................5.1-2959Levodopa.............................................................................5.6-4622Levodopum ........................................................................5.6-4622Levodropropizine ..............................................................5.7-5045Levodropropizinum.........................................................5.7-5045Levomenthol .............................................................................1907Levomentholum.......................................................................1907Levomepromazine hydrochloride.........................................1908Levomepromazine maleate ....................................................1908Levomepromazini hydrochloridum ...................................1908Levomepromazini maleas ....................................................1908Levomethadone hydrochloride .............................................1909Levomethadoni hydrochloridum ........................................1909Levonorgestrel .......................................................................... 1911Levonorgestrelum ................................................................... 1911Levothyroxine sodium .....................................................5.5-4264Levothyroxinum natricum ............................................5.5-4264Lichen islandicus .............................................................5.3-3525Lidocaine ................................................................................... 1913Lidocaine hydrochloride......................................................... 1914Lidocaini hydrochloridum ................................................... 1914Lidocainum .............................................................................. 1913Light liquid paraffin ................................................................ 2186Light magnesium carbonate...........................................5.3-3548Light magnesium oxide ...................................................5.6-4629Lime flower ............................................................................... 1914Limit tests (2.4.).......................................................................... 103Limit tests, standard solutions for (4.1.2.)...................5.7-4928Limit tests, standard solutions for (4.1.2.)...................5.8-5209Limonis aetheroleum ............................................................. 1895Lincomycin hydrochloride ..............................................5.4-3968Lincomycini hydrochloridum.......................................5.4-3968Lindane ...................................................................................... 1916Lindanum ................................................................................. 1916Linen thread, sterile, in distributor for veterinary use ..... 886Lini oleum virginale .............................................................. 1918Lini semen .........................................................................5.1-2960Linoleoyl macrogolglycerides.........................................5.5-4265Linseed ................................................................................5.1-2960Linseed oil, virgin .................................................................... 1918Liothyronine sodium............................................................... 1919Liothyroninum natricum ..................................................... 1919Lipophilic solid dosage forms, dissolution test for(2.9.42.) .............................................................................5.3-3373

Liquid and semi-solid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263

Liquid chromatography (2.2.29.) .............................................. 43Liquid extracts ...................................................................5.8-5221Liquid glucose .......................................................................... 1667Liquid glucose, spray-dried.................................................... 1668Liquid lactulose ........................................................................1890



Liquid maltitol ...................................................................5.5-4271Liquid paraffin .......................................................................... 2187Liquid preparations for cutaneous application ..........5.5-4159Liquid preparations for cutaneous application,veterinary .................................................................................. 630

Liquid preparations for inhalation ................................5.1-2843Liquid preparations for oral use....................................5.6-4471Liquids, clarity and degree of opalescence of(2.2.1.)................................................................................5.7-4777

Liquid sorbitol (crystallising) ................................................2471Liquid sorbitol (non-crystallising) ........................................2472Liquid sorbitol, partially dehydrated ...................................2473Liquiritiae extractum fluidum ethanolicum normatum ..5.3-3541

Liquiritiae radix ...............................................................5.5-4266Liquorice ethanolic liquid extract, standardised .......5.3-3541Liquorice root ....................................................................5.5-4266Lisinopril dihydrate .................................................................1922Lisinoprilum dihydricum .....................................................1922Lithii carbonas.........................................................................1923Lithii citras ...............................................................................1924Lithium carbonate ...................................................................1923Lithium citrate..........................................................................1924L-Methionine ([11C]methyl) injection...................................... 834L-Methionini ([11C]methyl) solutio iniectabilis .................. 834Lobeline hydrochloride...........................................................1925Lobelini hydrochloridum ......................................................1925Lomustine..................................................................................1926Lomustinum .............................................................................1926Loosestrife .................................................................................1927Loperamide hydrochloride.....................................................1928Loperamide oxide monohydrate...........................................1930Loperamidi hydrochloridum................................................1928Loperamidi oxidum monohydricum..................................1930Loratadine ..........................................................................5.6-4623Loratadinum .....................................................................5.6-4623Lorazepam..........................................................................5.6-4625Lorazepamum ...................................................................5.6-4625Loss on drying (2.2.32.).............................................................. 50Loss on drying of extracts (2.8.17.) ........................................ 222Lovage root................................................................................1932Lovastatin ..................................................................................1933Lovastatinum ...........................................................................1933Low-molecular-mass heparins ................................................1717Lozenges and pastilles .....................................................5.4-3846Lozenges, compressed .....................................................5.4-3846Lubricant, silicone oil (3.1.8.).................................................. 287Lupuli flos ................................................................................. 1730Lymecycline........................................................................5.4-3969Lymecyclinum ..................................................................5.4-3969Lynestrenol................................................................................1935Lynestrenolum .........................................................................1935Lyophilisates, oral .............................................................5.8-5239Lysine acetate ....................................................................5.3-3542Lysine hydrochloride...............................................................1936Lysini acetas......................................................................5.3-3542Lysini hydrochloridum..........................................................1936Lythri herba..............................................................................1927

MMacrogol 15 hydroxystearate ................................................ 1941Macrogol 20 glyceroli monostearas ............................5.5-4271Macrogol 20 glycerol monostearate .............................5.5-4271Macrogol 6 glycerol caprylocaprate..................................... 1941Macrogol 6 glyceroli caprylocapras ................................... 1941Macrogola..................................................................................1950Macrogol cetostearyl ether ....................................................1943Macrogolglyceridorum caprylocaprates ........................... 1173Macrogolglyceridorum laurates ...................................5.5-4263

Macrogolglyceridorum linoleates ................................5.5-4265Macrogolglyceridorum oleates .....................................5.5-4283Macrogolglyceridorum stearates..................................5.2-3274Macrogolglycerol cocoates.....................................................1947Macrogolglycerol hydroxystearate ................................5.2-3231Macrogolglyceroli cocoates ..................................................1947Macrogolglyceroli hydroxystearas...............................5.2-3231Macrogolglyceroli ricinoleas.........................................5.3-3547Macrogolglycerol ricinoleate ..........................................5.3-3547Macrogoli 15 hydroxystearas ............................................... 1941Macrogoli aether cetostearylicus ........................................1943Macrogoli aether laurilicum ................................................1944Macrogoli aether oleicum .....................................................1945Macrogoli aether stearylicus................................................1946Macrogoli oleas........................................................................1944Macrogoli stearas ....................................................................1946Macrogol lauryl ether .............................................................1944Macrogol oleate ........................................................................1944Macrogol oleyl ether ...............................................................1945Macrogols...................................................................................1950Macrogol stearate.....................................................................1946Macrogol stearyl ether............................................................1946Magaldrate................................................................................. 1951Magaldratum ............................................................................ 1951Magnesii acetas tetrahydricus .............................................1952Magnesii aspartas dihydricus ..............................................1953Magnesii chloridum 4.5-hydricum .....................................1955Magnesii chloridum hexahydricum ...................................1956Magnesii glycerophosphas ...................................................1957Magnesii hydroxidum ............................................................1957Magnesii lactas dihydricus ............................................5.7-5049Magnesii oxidum leve .....................................................5.6-4629Magnesii oxidum ponderosum .....................................5.6-4629Magnesii peroxidum...............................................................1959Magnesii pidolas .....................................................................1960Magnesii stearas ...................................................................... 1961Magnesii subcarbonas levis...........................................5.3-3548Magnesii subcarbonas ponderosus .............................5.3-3547Magnesii sulfas heptahydricus ............................................1962Magnesii trisilicas ...................................................................1963Magnesium (2.4.6.) .................................................................... 104Magnesium acetate tetrahydrate ..........................................1952Magnesium and alkaline-earth metals (2.4.7.) ..................... 104Magnesium aspartate dihydrate ...........................................1953Magnesium carbonate, heavy .........................................5.3-3547Magnesium carbonate, light ...........................................5.3-3548Magnesium chloride 4.5-hydrate ..........................................1955Magnesium chloride hexahydrate ........................................1956Magnesium glycerophosphate .............................................1957Magnesium hydroxide .............................................................1957Magnesium lactate dihydrate .........................................5.7-5049Magnesium oxide, heavy..................................................5.6-4629Magnesium oxide, light....................................................5.6-4629Magnesium peroxide ...............................................................1959Magnesium pidolate ................................................................1960Magnesium stearate................................................................. 1961Magnesium sulphate heptahydrate......................................1962Magnesium trisilicate ..............................................................1963Maize oil, refined......................................................................1964Maize starch .......................................................................5.1-2965Malathion...................................................................................1965Malathionum ............................................................................1965Maleic acid .................................................................................1966Malic acid ...................................................................................1966Mallow flower............................................................................1967Maltitol .......................................................................................1968Maltitol, liquid....................................................................5.5-4271Maltitolum .................................................................................1968Maltitolum liquidum........................................................5.5-4271



Maltodextrin..............................................................................1970Maltodextrinum .......................................................................1970Malvae sylvestris flos .............................................................1967Mandarin oil .......................................................................5.6-4630Manganese glycerophosphate, hydrated......................5.6-4631Manganese sulphate monohydrate ...................................... 1971Mangani glycerophosphas hydricus ...........................5.6-4631Mangani sulfas monohydricus ............................................ 1971Mannheimia vaccine (inactivated) for cattle ........................ 771Mannheimia vaccine (inactivated) for sheep........................ 772Mannitol ..............................................................................5.6-4631Mannitolum .......................................................................5.6-4631Maprotiline hydrochloride .....................................................1973Maprotilini hydrochloridum ................................................1973Marek’s disease vaccine (live).........................................5.6-4489Marrubii herba..................................................................5.1-3039Marshmallow leaf ..................................................................... 1974Marshmallow root .............................................................5.2-3232Mass spectrometry (2.2.43.)....................................................... 65Mass uniformity of delivered doses from multidose containers(2.9.27.) ...................................................................................... 263

Mass uniformity of single-dose preparations (2.9.5.) ......... 233Mastic..........................................................................................1975Masticabilia gummis medicata.....................................5.2-3136Mastix .........................................................................................1975Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291

Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 289

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272

Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 269

Materials used for the manufacture of containers (3.1.) ... 269Matricariae aetheroleum................................................5.1-2967Matricariae extractum fluidum ....................................5.1-2966Matricariae flos ................................................................5.1-2965Matricaria flower ...............................................................5.1-2965Matricaria liquid extract ..................................................5.1-2966Matricaria oil ......................................................................5.1-2967Maydis amylum ................................................................5.1-2965Maydis oleum raffinatum......................................................1964Meadowsweet ............................................................................1980Measles immunoglobulin, human ........................................ 1742Measles, mumps and rubella vaccine (live) .......................... 678Measles vaccine (live) ................................................................ 679Measurement of consistency by penetrometry (2.9.9.) ...... 235Mebendazole ............................................................................. 1981Mebendazolum......................................................................... 1981Meclozine hydrochloride ........................................................1982Meclozini hydrochloridum ...................................................1982Medicated chewing gum, dissolution test for(2.9.25.) .............................................................................5.2-3116

Medicated chewing gums ................................................5.2-3136Medicated feeding stuffs for veterinary use, premixes for ..617Medicated foams......................................................................... 604Medicated plasters ............................................................5.5-4165Medicated tampons.................................................................... 628Medicated vaginal tampons ............................................5.5-4170Medicinal air................................................................................ 929

Medicinal air, synthetic............................................................. 932Medium-chain triglycerides....................................................2623Medroxyprogesterone acetate ........................................5.3-3551Medroxyprogesteroni acetas .........................................5.3-3551Mefenamic acid .........................................................................1984Mefloquine hydrochloride......................................................1986Mefloquini hydrochloridum .................................................1986Megestrol acetate .....................................................................1987Megestroli acetas .....................................................................1987Meglumine..........................................................................5.4-3976Megluminum .....................................................................5.4-3976Mel........................................................................................5.1-2946Melaleucae aetheroleum .......................................................2534Melilot..................................................................................5.3-3552Meliloti herba ....................................................................5.3-3552Melissae folium ........................................................................1989Melissa leaf ................................................................................1989Melting point - capillary method (2.2.14.)............................... 32Melting point - instantaneous method (2.2.16.) .................... 33Melting point - open capillary method (2.2.15.) .................... 33Menadione .................................................................................1990Menadionum ............................................................................1990Meningococcal group C conjugate vaccine.......................... 680Meningococcal polysaccharide vaccine................................. 682Menthae arvensis aetheroleum partim mentholumdepletum...........................................................................5.2-3235

Menthae piperitae aetheroleum ..........................................2206Menthae piperitae folium .....................................................2205Menthol, racemic...................................................................... 1991Mentholum racemicum ......................................................... 1991Menyanthidis trifoliatae folium .......................................... 1115Mepivacaine hydrochloride....................................................1992Mepivacaini hydrochloridum ..............................................1992Meprobamate ............................................................................1993Meprobamatum........................................................................1993Mepyramine maleate ........................................................5.7-5049Mepyramini maleas .........................................................5.7-5049Mercaptopurine ........................................................................1995Mercaptopurinum ...................................................................1995Mercuric chloride .....................................................................1995Mesalazine .................................................................................1996Mesalazinum ............................................................................1996Mesna...................................................................................5.1-2971Mesnum ..............................................................................5.1-2971Mesterolone...............................................................................1999Mesterolonum ..........................................................................1999Mestranol ...................................................................................2000Mestranolum.............................................................................2000Metacresol ..........................................................................5.2-3232Metacresolum ....................................................................5.2-3232Metamizole sodium .................................................................2002Metamizolum natricum .........................................................2002Metformin hydrochloride .......................................................2003Metformini hydrochloridum ................................................2003Methacrylic acid - ethyl acrylate copolymer (1:1) ......5.7-5050Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent ..............................................................................2005

Methacrylic acid - methyl methacrylate copolymer (1:1) ..2006Methacrylic acid - methyl methacrylate copolymer (1:2) ..2007Methadone hydrochloride...............................................5.5-4272Methadoni hydrochloridum ..........................................5.5-4272Methanol .............................................................................5.2-3234Methanol and 2-propanol, test for (2.9.11.) .................5.3-3362Methanolum.......................................................................5.2-3234Methaqualone ...........................................................................2008Methaqualonum ......................................................................2008Methenamine ............................................................................2009Methenaminum .......................................................................2009Methionine ................................................................................ 2010



Methionine ([11C]methyl) injection, L-.................................... 834Methionine, DL- ......................................................................... 2010Methioninum............................................................................ 2010Methods in pharmacognosy (2.8.) .......................................... 215Methods of preparation of homoeopathic stocks andpotentisation....................................................................5.8-5260

Methods of preparation of sterile products (5.1.1.) ............ 445Methotrexate ......................................................................5.6-4633Methotrexatum ..................................................................5.6-4633Methylatropine bromide ......................................................... 2014Methylatropine nitrate ............................................................ 2015Methylatropini bromidum..................................................... 2014Methylatropini nitras ............................................................. 2015Methylcellulose..................................................................5.7-5051Methylcellulosum .............................................................5.7-5051Methyldopa................................................................................ 2016Methyldopum ........................................................................... 2016Methylene blue ..................................................................5.4-3977Methylene chloride .................................................................. 2017Methyleni chloridum .............................................................. 2017Methylhydroxyethylcellulose ................................................. 2018Methylhydroxyethylcellulosum............................................ 2018Methylis nicotinas ............................................................5.1-2972Methylis parahydroxybenzoas ............................................. 2013Methylis parahydroxybenzoas natricum .......................... 2441Methylis salicylas .................................................................... 2014Methyl nicotinate ..............................................................5.1-2972Methyl parahydroxybenzoate ................................................ 2013Methylpentoses in polysaccharide vaccines (2.5.21.) ......... 133Methylphenobarbital ............................................................... 2019Methylphenobarbitalum ........................................................ 2019Methylprednisolone.................................................................2020Methylprednisolone acetate...................................................2022Methylprednisolone hydrogen succinate ............................2024Methylprednisoloni acetas....................................................2022Methylprednisoloni hydrogenosuccinas ...........................2024Methylprednisolonum ............................................................2020Methylpyrrolidone, N- .............................................................2026Methylrosanilinii chloridum .........................................5.1-2973Methylrosanilinium chloride ..........................................5.1-2973Methyl salicylate....................................................................... 2014Methyltestosterone ..................................................................2027Methyltestosteronum ..............................................................2027Methylthioninii chloridum ............................................5.4-3977Methylthioninium chloride .............................................5.4-3977Metixene hydrochloride ..........................................................2029Metixeni hydrochloridum .....................................................2029Metoclopramide.................................................................5.7-5053Metoclopramide hydrochloride............................................. 2031Metoclopramidi hydrochloridum ........................................ 2031Metoclopramidum ............................................................5.7-5053Metolazone .........................................................................5.8-5333Metolazonum.....................................................................5.8-5333Metoprololi succinas ..............................................................2032Metoprololi tartras ..................................................................2034Metoprolol succinate...............................................................2032Metoprolol tartrate ..................................................................2034Metrifonate ................................................................................2035Metrifonatum............................................................................2035Metronidazole ...........................................................................2037Metronidazole benzoate .........................................................2038Metronidazoli benzoas ..........................................................2038Metronidazolum ......................................................................2037Mexiletine hydrochloride........................................................2039Mexiletini hydrochloridum...................................................2039Mianserin hydrochloride ........................................................ 2041Mianserini hydrochloridum ................................................. 2041Miconazole ................................................................................2042Miconazole nitrate ...................................................................2043

Miconazoli nitras ....................................................................2043Miconazolum............................................................................2042Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ......................................5.6-4398

Microbiological assay of antibiotics (2.7.2.).......................... 188Microbiological control of cellular products(2.6.27.) .............................................................................5.6-4414

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ............................5.6-4404

Microbiological examination of non-sterile products : totalviable aerobic count (2.6.12.) .......................................5.6-4398

Microbiological quality, alternative methods for control of(5.1.6.)................................................................................5.5-4131

Microbiological quality of pharmaceutical preparations(5.1.4.)................................................................................5.6-4451

Microcrystalline cellulose................................................5.7-4985Micro determination of water (2.5.32.).................................. 137Microscopy, optical (2.9.37.) ...........................................5.3-3366Midazolam ..........................................................................5.4-3979Midazolamum ...................................................................5.4-3979Milk thistle dry extract, refined and standardised.....5.6-4635Milk-thistle fruit.................................................................5.7-5055Millefolii herba..................................................................5.7-5145Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 463

Minocycline hydrochloride dihydrate ...........................5.7-5056Minocyclini hydrochloridum dihydricum .................5.7-5056Minoxidil .............................................................................5.1-2974Minoxidilum ......................................................................5.1-2974Mint oil, partly dementholised .......................................5.2-3235Mirtazapine ........................................................................5.8-5334Mirtazapinum ...................................................................5.8-5334Misoprostol.........................................................................5.3-3553Misoprostolum ..................................................................5.3-3553Mitomycin .................................................................................. 2051Mitomycinum ........................................................................... 2051Mitoxantrone hydrochloride...........................................5.6-4637Mitoxantroni hydrochloridum ......................................5.6-4637Modafinil .............................................................................5.6-4638Modafinilum ......................................................................5.6-4638Modified-release capsules................................................5.5-4156Modified-release granules ............................................... 5.2-3141Modified-release tablets ...................................................5.8-5240Molecular mass distribution in dextrans (2.2.39.) ................ 57Molgramostim concentrated solution .................................2054Molgramostimi solutio concentrata ...................................2054Mometasone furoate.........................................................5.7-5058Mometasoni furoas ..........................................................5.7-5058Monoclonal antibodies for human use.........................5.8-5224Morantel hydrogen tartrate for veterinary use ..........5.7-5059Moranteli hydrogenotartras ad usum veterinarium ........5.7-5059

Morphine hydrochloride..................................................5.2-3237Morphine sulphate............................................................5.2-3238Morphini hydrochloridum .............................................5.2-3237Morphini sulfas.................................................................5.2-3238Moss, Iceland .....................................................................5.3-3525Mother tinctures for homoeopathic preparations .............. 894Motherwort ...............................................................................2063Mouthwashes .....................................................................5.4-3845Moxifloxacin hydrochloride ............................................5.8-5335Moxifloxacini hydrochloridum ....................................5.8-5335Moxonidine ................................................................................2064Moxonidinum ...........................................................................2064Mucoadhesive preparations ............................................5.4-3847Mullein flower...........................................................................2065Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 263



Mumps vaccine (live) ................................................................. 684Mupirocin...................................................................................2065Mupirocin calcium ...................................................................2067Mupirocinum............................................................................2065Mupirocinum calcicum .........................................................2067Musci medicati........................................................................... 604Mycobacteria (2.6.2.) ................................................................. 149Mycophenolas mofetil .....................................................5.2-3239Mycophenolate mofetil.....................................................5.2-3239Mycoplasma gallisepticum vaccine (inactivated)........5.6-4491Mycoplasmas (2.6.7.).........................................................5.8-5201myo-Inositol .......................................................................5.8-5325myo-Inositolum.................................................................5.8-5325Myristicae fragrantis aetheroleum ..................................... 2123Myrrh ..........................................................................................2069Myrrha .......................................................................................2069Myrrhae tinctura .....................................................................2069Myrrh tincture ..........................................................................2069Myrtilli fructus recens............................................................ 1099Myrtilli fructus siccus............................................................. 1099Myxomatosis vaccine (live) for rabbits .................................. 775

NNabumetone ..............................................................................2073Nabumetonum .........................................................................2073N-Acetyltryptophan.....................................................................918N-Acetyltryptophanum..............................................................918N-Acetyltyrosine ......................................................................... 920N-Acetyltyrosinum .................................................................... 920Nadolol ....................................................................................... 2074Nadololum................................................................................. 2074Nadroparin calcium .................................................................2075Nadroparinum calcicum .......................................................2075Naftidrofuryl hydrogen oxalate.............................................2078Naftidrofuryli hydrogenooxalas ..........................................2078Nalidixic acid.............................................................................2080Naloxone hydrochloride dihydrate................................5.7-5063Naloxoni hydrochloridum dihydricum ......................5.7-5063Naltrexone hydrochloride................................................5.1-2979Naltrexoni hydrochloridum ...........................................5.1-2979Nandrolone decanoate .....................................................5.5-4277Nandroloni decanoas ......................................................5.5-4277Naphazoline hydrochloride....................................................2082Naphazoline nitrate ..........................................................5.3-3561Naphazolini hydrochloridum ..............................................2082Naphazolini nitras ...........................................................5.3-3561Naproxen.............................................................................5.2-3245Naproxen sodium ..............................................................5.6-4643Naproxenum ......................................................................5.2-3245Naproxenum natricum ...................................................5.6-4643Narrow-leaved coneflower root ......................................5.7-5064Nasal drops and liquid nasal sprays..............................5.6-4473Nasalia ................................................................................5.6-4473Nasal powders....................................................................5.6-4474Nasal preparations ............................................................5.6-4473Nasal preparations, semi-solid........................................5.6-4474Nasal sprays (liquid) and nasal drops ...........................5.6-4473Nasal sticks.........................................................................5.6-4474Nasal washes ......................................................................5.6-4474Natrii acetas trihydricus ....................................................... 2415Natrii acetatis ([1-11C]) solutio iniectabilis ................5.4-3885Natrii alendronas .................................................................... 2416Natrii alginas ........................................................................... 2417Natrii amidotrizoas ................................................................ 2418Natrii aminosalicylas dihydricus........................................ 2419Natrii ascorbas ..................................................................5.6-4679Natrii aurothiomalas.......................................................5.8-5363Natrii benzoas .......................................................................... 2421Natrii bromidum......................................................................2422

Natrii calcii edetas ...........................................................5.7-5107Natrii caprylas .........................................................................2423Natrii carbonas anhydricus...........................................5.1-3008Natrii carbonas decahydricus.......................................5.1-3008Natrii carbonas monohydricus.....................................5.1-3009Natrii cetylo- et stearylosulfas. ............................................2426Natrii chloridum......................................................................2428Natrii chromatis (51Cr) solutio sterilis ................................. 840Natrii citras ...............................................................................2429Natrii cromoglicas ..................................................................2429Natrii cyclamas ........................................................................2430Natrii dihydrogenophosphas dihydricus .......................... 2431Natrii docusas ...................................................................5.6-4565Natrii fluoridi (18F) solutio iniectabilis................................ 841Natrii fluoridum ......................................................................2432Natrii fusidas ............................................................................2433Natrii glycerophosphas hydricus ........................................2434Natrii hyaluronas ....................................................................2434Natrii hydrogenocarbonas....................................................2437Natrii hydroxidum ..................................................................2437Natrii iodidi (123I) solutioad radio-signandum .........5.5-4181Natrii iodidi (123I) solutio iniectabilis .................................. 842Natrii iodidi (131I) capsulae ad usum diagnosticum......... 843Natrii iodidi (131I) capsulae ad usum therapeuticum.......5.2-3157

Natrii iodidi (131I) solutio......................................................... 844Natrii iodidi (131I) solutio ad radio-signandum ................. 845Natrii iodidum .........................................................................2438Natrii iodohippurati (123I) solutio iniectabilis ................... 845Natrii iodohippurati (131I) solutio iniectabilis.................... 846Natrii lactatis solutio ..............................................................2438Natrii laurilsulfas ....................................................................2440Natrii metabisulfis .................................................................. 2441Natrii molybdas dihydricus ..................................................2442Natrii molybdatis (99Mo) fissione formati solutio ....5.7-4959Natrii nitris ...............................................................................2443Natrii nitroprussias ................................................................2443Natrii perboras hydricus .......................................................2444Natrii pertechnetatis (99mTc) fissione formati solutioiniectabilis ................................................................................ 847

Natrii pertechnetatis (99mTc) sine fissione formati solutioiniectabilis ................................................................................ 848

Natrii phosphatis (32P) solutio iniectabilis ......................... 849Natrii picosulfas ......................................................................2445Natrii polystyrenesulfonas....................................................2446Natrii propionas ......................................................................2447Natrii salicylas .........................................................................2449Natrii selenis pentahydricus .........................................5.4-4018Natrii (S)-lactatis solutio .......................................................2439Natrii stearas .....................................................................5.7-5108Natrii stearylis fumaras .........................................................2453Natrii sulfas anhydricus ........................................................2454Natrii sulfas decahydricus ....................................................2455Natrii sulfis anhydricus ..................................................5.6-4679Natrii sulfis heptahydricus ............................................5.6-4680Natrii thiosulfas ................................................................5.1-3009Natrii valproas .........................................................................2457Near-infrared spectrophotometry (2.2.40.) ............................. 59Neohesperidin-dihydrochalcone ...........................................2085Neohesperidin-dihydrochalconum .....................................2085Neomycini sulfas .....................................................................2086Neomycin sulphate ..................................................................2086Neonatal piglet colibacillosis vaccine (inactivated) ............ 776Neonatal ruminant colibacillosis vaccine (inactivated) ..... 778Neostigmine bromide ..............................................................2088Neostigmine metilsulfate........................................................2089Neostigmini bromidum..........................................................2088Neostigmini metilsulfas .........................................................2089Neroli aetheroleum ..........................................................5.3-3562



Neroli oil .............................................................................5.3-3562Netilmicini sulfas ....................................................................2089Netilmicin sulphate..................................................................2089Nettle leaf............................................................................5.6-4644Neurovirulence test for poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172

Neurovirulence test of live viral vaccines (2.6.18.) ............. 172Nevirapine, anhydrous.....................................................5.4-3985Nevirapinum anhydricum .............................................5.4-3985Newcastle disease vaccine (inactivated) .......................5.6-4492Newcastle disease vaccine (live).............................................. 781Nicergoline ................................................................................ 2091Nicergolinum ........................................................................... 2091Nicethamidum ......................................................................... 2100Nickel in hydrogenated vegetable oils (2.4.31.)..........5.7-4781Nickel in polyols (2.4.15.) ......................................................... 108Niclosamide, anhydrous .........................................................2092Niclosamide monohydrate .....................................................2093Niclosamidum anhydricum..................................................2092Niclosamidum monohydricum............................................2093Nicotinamide .............................................................................2094Nicotinamidum........................................................................2094Nicotine ......................................................................................2095Nicotine resinate ......................................................................2096Nicotinic acid ............................................................................2097Nicotini resinas .......................................................................2096Nicotinum .................................................................................2095Nifedipine...................................................................................2098Nifedipinum..............................................................................2098Nifuroxazide ..............................................................................2099Nifuroxazidum .........................................................................2099Nikethamide .............................................................................. 2100Nimesulide..........................................................................5.8-5339Nimesulidum .....................................................................5.8-5339Nimodipine .........................................................................5.4-3986Nimodipinum ....................................................................5.4-3986Nitrazepam ................................................................................ 2103Nitrazepamum ......................................................................... 2103Nitrendipine .............................................................................. 2104Nitrendipinum ......................................................................... 2104Nitric acid .................................................................................. 2105Nitric oxide ................................................................................ 2105Nitrofural ................................................................................... 2106Nitrofuralum............................................................................. 2106Nitrofurantoin........................................................................... 2107Nitrofurantoinum.................................................................... 2107Nitrogen ..................................................................................... 2108Nitrogen determination by sulphuric acid digestion(2.5.9.) ........................................................................................ 129

Nitrogen determination, primary aromatic amino(2.5.8.) ........................................................................................ 129

Nitrogenii oxidum................................................................... 2105Nitrogenium ............................................................................. 2108Nitrogenium oxygenio depletum ........................................ 2109Nitrogen, low-oxygen............................................................... 2109Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) ...................................................................................... 135

Nitrous oxide......................................................................5.7-5067Nitrous oxide in gases (2.5.35.)................................................141Nizatidine....................................................................................2111Nizatidinum...............................................................................2111N-Methylpyrrolidone................................................................2026N-Methylpyrrolidonum ..........................................................2026N,N-Dimethylaniline (2.4.26.) ...................................................119Nomegestrol acetate.........................................................5.6-4646Nomegestroli acetas.........................................................5.6-4646Nonoxinol 9................................................................................2114Nonoxinolum 9 .........................................................................2114

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) ...........................5.6-4404

Non-sterile products, microbiological examination of (totalviable aerobic count) (2.6.12.)......................................5.6-4398

Noradrenaline hydrochloride .........................................5.7-5068Noradrenaline tartrate .....................................................5.7-5070Noradrenalini hydrochloridum ....................................5.7-5068Noradrenalini tartras ......................................................5.7-5070Norcholesteroli iodinati (131I) solutio iniectabilis ............. 836Norcholesterol injection, iodinated (131I) .............................. 836Norethisterone...................................................................5.5-4278Norethisterone acetate ............................................................2117Norethisteroni acetas ..............................................................2117Norethisteronum ..............................................................5.5-4278Norfloxacin................................................................................ 2118Norfloxacinum......................................................................... 2118Norgestrel .................................................................................. 2119Norgestrelum ............................................................................ 2119Normal immunoglobulin for intravenous administration,human ...............................................................................5.6-4601

Normal immunoglobulin, human ..................................5.6-4599Nortriptyline hydrochloride............................................5.3-3565Nortriptylini hydrochloridum.......................................5.3-3565Noscapine .................................................................................. 2121Noscapine hydrochloride........................................................ 2122Noscapini hydrochloridum................................................... 2122Noscapinum.............................................................................. 2121Nuclear magnetic resonance spectrometry (2.2.33.).............51Nucleic acid amplification techniques (2.6.21.) .......... 5.5-4111Nucleic acids in polysaccharide vaccines (2.5.17.) .............. 132Numeration of CD34/CD45+ cells in haematopoieticproducts (2.7.23.) ............................................................5.6-4421

Nutmeg oil ................................................................................. 2123Nystatin ...................................................................................... 2124Nystatinum ............................................................................... 2124

OO-Acetyl in polysaccharide vaccines (2.5.19.) ...................... 132Oak bark .................................................................................... 2129Octoxinol 10 .......................................................................5.2-3251Octoxinolum 10 ................................................................5.2-3251Octyldodecanol ..................................................................5.6-4651Octyldodecanolum ...........................................................5.6-4651Octyl gallate .............................................................................. 2129Octylis gallas ............................................................................ 2129Odour (2.3.4.)................................................................................ 99Odour and taste of essential oils (2.8.8.) ...............................216Oenotherae oleum raffinatum ......................................5.5-4227Ofloxacin.................................................................................... 2131Ofloxacinum............................................................................. 2131Oils, essential .....................................................................5.8-5218Oils, fatty, vegetable .........................................................5.8-5233Oils rich in omega-3- acids, composition of fatty acids in(2.4.29.) .............................................................................5.5-4107

Oils rich in omega-3 acids, total cholesterol in(2.4.32.) .............................................................................5.8-5197

Ointments ...........................................................................5.5-4165Oleae folium ......................................................................5.8-5343Olea herbaria ...................................................................5.8-5233Oleic acid ................................................................................... 2132Oleoyl macrogolglycerides..............................................5.5-4283Oleyl alcohol ............................................................................. 2134Olibanum indicum...........................................................5.7-5031Olivae oleum raffinatum ................................................5.4-3991Olivae oleum virginale .......................................................... 2136Olive leaf .............................................................................5.8-5343Olive oil, refined ................................................................5.4-3991Olive oil, virgin ......................................................................... 2136Olsalazine sodium.............................................................5.7-5075



Olsalazinum natricum....................................................5.7-5075Omega-3-acid ethyl esters 60..........................................5.4-3992Omega-3-acid ethyl esters 90..........................................5.3-3571Omega-3 acidorum esteri ethylici 60..........................5.4-3992Omega-3 acidorum esteri ethylici 90..........................5.3-3571Omega-3 acidorum triglycerida ...................................5.4-3995Omega-3-acids, composition of fatty acids in oils rich in(2.4.29.) .............................................................................5.5-4107

Omega-3-acids, fish oil rich in ........................................5.4-3941Omega-3 acids, total cholesterol in oils rich in(2.4.32.) .............................................................................5.8-5197

Omega-3-acid triglycerides ..............................................5.4-3995Omeprazole ........................................................................5.2-3251Omeprazole sodium................................................................. 2148Omeprazolum....................................................................5.2-3251Omeprazolum natricum ........................................................ 2148Ondansetron hydrochloride dihydrate ................................ 2149Ondansetroni hydrochloridum dihydricum .................... 2149Ononidis radix ......................................................................... 2361Opalescence of liquids, clarity and degree of (2.2.1.) ..5.7-4777Ophthalmica ......................................................................5.5-4157Ophthalmic inserts ...........................................................5.5-4159Opii extractum siccum normatum...............................5.7-5077Opii pulvis normatus ......................................................5.3-3573Opii tinctura normata.....................................................5.7-5078Opium crudum .................................................................5.3-3575Opium dry extract, standardised ...................................5.7-5077Opium, prepared................................................................5.3-3573Opium, raw .........................................................................5.3-3575Opium tincture, standardised.........................................5.7-5078Optical microscopy (2.9.37.) ...........................................5.3-3366Optical rotation (2.2.7.)....................................................5.6-4383Oral drops ...........................................................................5.6-4472Oral lyophilisates...............................................................5.8-5239Oral powders......................................................................5.2-3147Oral solutions, emulsions and suspensions ................5.6-4471Oral use, liquid preparations for....................................5.6-4471Orciprenaline sulphate.....................................................5.3-3576Orciprenalini sulfas .........................................................5.3-3576Oregano...................................................................................... 2155Organ preservation, solutions for.........................................2458Oriental cashew for homoeopathic preparations.......5.3-3430Origani herba ........................................................................... 2155Orodispersible tablets ......................................................5.8-5240Oromucosal capsules .......................................................5.4-3847Oromucosal drops, oromucosal sprays and sublingualsprays.................................................................................5.4-3845

Oromucosal preparations................................................5.4-3844Oromucosal preparations, semi-solid............................5.4-3845Oromucosal solutions and oromucosal suspensions .........5.4-3845

Oromucosal sprays, oromucosal drops and sublingualsprays.................................................................................5.4-3844

Oromucosal suspensions and oromucosal solutions .........5.4-3844

Orphenadrine citrate............................................................... 2156Orphenadrine hydrochloride................................................. 2157Orphenadrini citras ................................................................ 2156Orphenadrini hydrochloridum............................................ 2157Orthosiphonis folium ......................................................5.6-4617Oryzae amylum .......................................................................2369Osmolality (2.2.35.)...................................................................... 54Ouabain...................................................................................... 2158Ouabainum ............................................................................... 2158Oxacillin sodium monohydrate ......................................5.6-4651Oxacillinum natricum monohydricum ......................5.6-4651Oxaliplatin ................................................................................. 2159Oxaliplatinum .......................................................................... 2159Oxazepam ...........................................................................5.5-4283

Oxazepamum ....................................................................5.5-4283Oxeladin hydrogen citrate...................................................... 2163Oxeladini hydrogenocitras ................................................... 2163Oxfendazole for veterinary use ............................................. 2164Oxfendazolum ad usum veterinarium .............................. 2164Oxidising substances (2.5.30.)................................................. 137Oxitropii bromidum.........................................................5.6-4653Oxitropium bromide .........................................................5.6-4653Oxolinic acid.............................................................................. 2165Oxprenolol hydrochloride ...................................................... 2166Oxprenololi hydrochloridum .............................................. 2166Oxybuprocaine hydrochloride............................................... 2167Oxybuprocaini hydrochloridum ......................................... 2167Oxybutynin hydrochloride ..............................................5.7-5079Oxybutynini hydrochloridum .......................................5.7-5079Oxycodone hydrochloride ...............................................5.1-2987Oxycodoni hydrochloridum ..........................................5.1-2987Oxygen........................................................................................ 2169Oxygen (15O) ................................................................................ 837Oxygen-flask method (2.5.10.)................................................. 130Oxygen in gases (2.5.27.).......................................................... 136Oxygenium................................................................................ 2169Oxygenium (15O) ........................................................................ 837Oxymetazoline hydrochloride ............................................... 2170Oxymetazolini hydrochloridum .......................................... 2170Oxytetracycline dihydrate ...............................................5.5-4285Oxytetracycline hydrochloride .......................................5.5-4286Oxytetracyclini hydrochloridum ..................................5.5-4286Oxytetracyclinum dihydricum......................................5.5-4285Oxytocin ..............................................................................5.8-5344Oxytocin concentrated solution.....................................5.8-5345Oxytocini solutio concentrata.......................................5.8-5345Oxytocinum .......................................................................5.8-5344

PPaclitaxel.............................................................................5.8-5349Paclitaxelum ......................................................................5.8-5349Pale coneflower root ........................................................5.7-5085Palmitic acid.............................................................................. 2179Pamidronate disodium pentahydrate ...........................5.4-4003Pancreas powder ...............................................................5.6-4659Pancreatis pulvis ..............................................................5.6-4659Pancuronii bromidum ....................................................5.5-4291Pancuronium bromide .....................................................5.5-4291Pansy, wild (flowering aerial parts) .....................................2700Papaverine hydrochloride ...................................................... 2183Papaverini hydrochloridum ................................................. 2183Papaveris rhoeados flos ........................................................2359Paper chromatography (2.2.26.) ............................................... 40Paracetamol .............................................................................. 2184Paracetamolum........................................................................ 2184Paraffin, hard ............................................................................ 2186Paraffin, light liquid ................................................................ 2186Paraffin, liquid .......................................................................... 2187Paraffinum liquidum.............................................................. 2187Paraffinum perliquidum ....................................................... 2186Paraffinum solidum................................................................ 2186Paraffin, white soft .................................................................. 2187Paraffin, yellow soft................................................................. 2188Parainfluenza virus vaccine (live), bovine, freeze-dried .... 732Parainfluenza virus vaccine (live), canine ............................ 742Paraldehyde............................................................................... 2189Paraldehydum .......................................................................... 2189Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ..................................................................................5.6-4492

Parenteralia .......................................................................5.2-3144Parenteral preparations...................................................5.2-3144Parenteral preparations, test for extractable volume of(2.9.17.)..............................................................................5.3-3363



Parnaparin sodium .................................................................. 2189Parnaparinum natricum....................................................... 2189Paroxetine hydrochloride, anhydrous ..........................5.7-5086Paroxetine hydrochloride hemihydrate........................5.7-5089Paroxetini hydrochloridum anhydricum...................5.7-5086Paroxetini hydrochloridum hemihydricum ..............5.7-5089Particles, fine, aerodynamic assessment of in preparationsfor inhalation (2.9.18.) ...................................................5.2-3103

Particle size analysis by laser light diffraction(2.9.31.) .............................................................................5.6-4429

Particle-size distribution estimation by analytical sieving(2.9.38.) .............................................................................5.3-3368

Particulate contamination : sub-visible particles(2.9.19.) ...................................................................................... 253

Particulate contamination : visible particles (2.9.20.)........ 255Parvovirosis vaccine (inactivated), canine ............................ 743Parvovirosis vaccine (inactivated), porcine .......................... 787Parvovirosis vaccine (live), canine.......................................... 744Passiflorae herba..................................................................... 2192Passiflorae herbae extractum siccum .........................5.3-3585Passion flower .......................................................................... 2192Passion flower dry extract ..............................................5.3-3585Pastes...................................................................................5.5-4165Pasteurella vaccine (inactivated) for sheep .......................... 783Pastilles and lozenges ......................................................5.4-3846Patches, transdermal........................................................5.2-3146Patches, transdermal, dissolution test for (2.9.4.) .............. 231Pefloxacini mesilas dihydricus ........................................... 2193Pefloxacin mesilate dihydrate ............................................... 2193Pelargonii radix ................................................................5.7-5091Pelargonium root ..............................................................5.7-5091Penbutololi sulfas .................................................................... 2195Penbutolol sulphate ................................................................ 2195Penetrometry, measurement of consistency (2.9.9.) .......... 235Penicillamine......................................................................5.3-3586Penicillaminum ................................................................5.3-3586Pentaerythrityli tetranitras dilutus..................................... 2198Pentaerythrityl tetranitrate, diluted .................................... 2198Pentamidine diisetionate.................................................5.3-3588Pentamidini diisetionas .................................................5.3-3588Pentazocine........................................................................5.1-2991Pentazocine hydrochloride .............................................5.1-2991Pentazocine lactate ..........................................................5.1-2992Pentazocini hydrochloridum ........................................5.1-2991Pentazocini lactas ............................................................5.1-2992Pentazocinum ...................................................................5.1-2991Pentobarbital ............................................................................ 2201Pentobarbital sodium..............................................................2202Pentobarbitalum ...................................................................... 2201Pentobarbitalum natricum ...................................................2202Pentoxifylline .....................................................................5.2-3258Pentoxifyllinum ................................................................5.2-3258Pentoxyverine hydrogen citrate ............................................2204Pentoxyverini hydrogenocitras ...........................................2204Peppermint leaf ........................................................................2205Peppermint oil ..........................................................................2206Pepsini pulvis ...........................................................................2207Pepsin powder ..........................................................................2207Peptide mapping (2.2.55.) .......................................................... 82Peptides, synthetic, acetic acid in (2.5.34.)............................141Pergolide mesilate....................................................................2209Pergolidi mesilas .....................................................................2209Perindopril tert-butylamine.............................................5.3-3589Peritoneal dialysis, solutions for........................................... 2212Peroxide value (2.5.5.)............................................................... 128Perphenazine ............................................................................ 2214Perphenazinum ....................................................................... 2214Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed)..........................................................5.4-3851

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ......................5.4-3854

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3856

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4483

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3858

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................5.4-3861

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)..........................................................5.4-3864

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866

Pertussis vaccine........................................................................ 685Pertussis vaccine (acellular), assay of (2.7.16.) .................... 208Pertussis vaccine (acellular, component, adsorbed) ..5.3-3407Pertussis vaccine (acellular, co-purified, adsorbed) ........... 688Pertussis vaccine (adsorbed) ................................................... 690Pertussis vaccine, assay of (2.7.7.) .......................................... 197Peru balsam............................................................................... 2215Pessaries..............................................................................5.5-4168Pessaries and suppositories, disintegration of (2.9.2.) ...... 227Pessaries and suppositories, resistance to rupture(2.9.24.) ...................................................................................... 258

Pesticide residues (2.8.13.)........................................................218Pethidine hydrochloride ......................................................... 2216Pethidini hydrochloridum .................................................... 2216Pharmaceutical technical procedures (2.9.)......................... 225Pharmacognosy, methods in (2.8.)......................................... 215Pharmacopoeial harmonisation (5.8.) ................................... 551Phenazone................................................................................. 2217Phenazonum ............................................................................ 2217Pheniramine maleate .............................................................. 2218Pheniramini maleas ............................................................... 2218Phenobarbital ........................................................................... 2219Phenobarbital sodium.............................................................2220Phenobarbitalum..................................................................... 2219Phenobarbitalum natricum ..................................................2220Phenol ........................................................................................ 2221Phenol in immunosera and vaccines (2.5.15.) ......................131Phenolphthalein.......................................................................2222Phenolphthaleinum................................................................2222Phenolsulfonphthalein ...........................................................2222Phenolsulfonphthaleinum ....................................................2222Phenolum .................................................................................. 2221Phenothiazines, identification by thin-layer chromatography(2.3.3.) .......................................................................................... 99

Phenoxyethanol........................................................................2223Phenoxyethanolum ................................................................2223Phenoxymethylpenicillin .................................................5.1-2992Phenoxymethylpenicillin potassium.............................5.3-3591Phenoxymethylpenicillinum.........................................5.1-2992Phenoxymethylpenicillinum kalicum ........................5.3-3591Phentolamine mesilate ...........................................................2227Phentolamini mesilas ............................................................2227Phenylalanine ...........................................................................2228Phenylalaninum......................................................................2228Phenylbutazone .......................................................................2229Phenylbutazonum...................................................................2229Phenylephrine....................................................................5.7-5092Phenylephrine hydrochloride.........................................5.7-5093Phenylephrini hydrochloridum ...................................5.7-5093Phenylephrinum ..............................................................5.7-5092



Phenylhydrargyri acetas .......................................................2232Phenylhydrargyri boras.........................................................2233Phenylhydrargyri nitras ........................................................2234Phenylmercuric acetate ..........................................................2232Phenylmercuric borate ...........................................................2233Phenylmercuric nitrate ...........................................................2234Phenylpropanolamine hydrochloride ..................................2234Phenylpropanolamini hydrochloridum ............................2234Phenytoin...................................................................................2235Phenytoin sodium....................................................................2236Phenytoinum............................................................................2235Phenytoinum natricum .........................................................2236Phloroglucinol, anhydrous .............................................5.3-3593Phloroglucinol dihydrate ................................................5.3-3594Phloroglucinolum anhydricum....................................5.3-3593Phloroglucinolum dihydricum .....................................5.3-3594Pholcodine.................................................................................2237Pholcodinum ............................................................................2237Phosphates (2.4.11.) .................................................................. 108Phosphoric acid, concentrated .............................................2237Phosphoric acid, dilute ...........................................................2238Phosphorus in polysaccharide vaccines (2.5.18.) ............... 132pH, potentiometric determination of (2.2.3.) ......................... 26Phthalylsulfathiazole ..............................................................2238Phthalylsulfathiazolum .........................................................2238Physical and physicochemical methods (2.2.) ....................... 23Physostigmine salicylate.........................................................2239Physostigmine sulphate..........................................................2240Physostigmini salicylas .........................................................2239Physostigmini sulfas ..............................................................2240Phytomenadione ...............................................................5.6-4661Phytomenadionum ..........................................................5.6-4661Phytosterol .........................................................................5.6-4663Phytosterolum ...................................................................5.6-4663Picotamide monohydrate .......................................................2243Picotamidum monohydricum..............................................2243Pilocarpine hydrochloride......................................................2244Pilocarpine nitrate ...................................................................2246Pilocarpini hydrochloridum ................................................2244Pilocarpini nitras ....................................................................2246Pimobendan .......................................................................5.3-3594Pimobendanum ................................................................5.3-3594Pimozide ....................................................................................2247Pimozidum ...............................................................................2247Pindolol ......................................................................................2248Pindololum ...............................................................................2248Pine (dwarf) oil ..................................................................5.8-5304Pine silvestris oil ...............................................................5.5-4292Pini pumilionis aetheroleum ........................................5.8-5304Pini silvestris aetheroleum ............................................5.5-4292Pinus pinaster type turpentine oil ................................5.6-4703Pipemidic acid trihydrate .......................................................2249Piperacillin ................................................................................2250Piperacillin sodium..................................................................2252Piperacillinum ........................................................................2250Piperacillinum natricum ......................................................2252Piperazine adipate ...................................................................2253Piperazine citrate.....................................................................2254Piperazine hydrate...................................................................2255Piperazini adipas ....................................................................2253Piperazini citras ......................................................................2254Piperazinum hydricum .........................................................2255Piracetam............................................................................5.4-4006Piracetamum .....................................................................5.4-4006Pirenzepine dihydrochloride monohydrate .......................2257Pirenzepini dihydrochloridum monohydricum .............2257Piretanide ..................................................................................2258Piretanidum..............................................................................2258Piroxicam ...................................................................................2259

Piroxicamum............................................................................2259Piscis oleum omega-3 acidis abundans .....................5.4-3941Pivampicillin.............................................................................. 2261Pivampicillinum ...................................................................... 2261Pivmecillinam hydrochloride.................................................2262Pivmecillinami hydrochloridum ........................................2262Plantae ad ptisanam ................................................................ 573Plantae medicinales ................................................................. 572Plantae medicinales ad praeparationeshomoeopathicas .............................................................5.2-3161

Plantae medicinales praeparatore ....................................... 572Plantaginis lanceolatae folium ...........................................2368Plantaginis ovatae semen ..................................................... 1850Plantaginis ovatae seminis tegumentum ..................5.7-5037Plasma for fractionation, human...................................5.6-4603Plasma humanum ad separationem ...........................5.6-4603Plasma humanum coagmentatum conditumque adexstinguendum virum ..................................................5.6-4604

Plasma (pooled and treated for virus inactivation),human ...............................................................................5.6-4604

Plasmid vectors for human use......................................5.6-4466Plasmid vectors for human use, bacterial cells used for themanufacture of ................................................................5.6-4468

Plasters, medicated...........................................................5.5-4164Plastic additives (3.1.13.).......................................................... 293Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 308

Plastic containers for aqueous solutions for parenteralinfusion (3.2.2.1.) ..................................................................... 309

Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 309

Plastic syringes, single-use, sterile (3.2.8.) ............................314Pneumococcal polysaccharide conjugate vaccine(adsorbed).........................................................................5.5-4177

Pneumococcal polysaccharide vaccine ................................. 691Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ...............5.4-3856

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4483

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)..........................................................5.4-3864

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)..........................................................5.4-3861

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ..........................5.4-3858

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866

Poliomyelitis vaccine (inactivated) ................................5.4-3868Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) .............................................................................5.6-4420

Poliomyelitis vaccine (oral) .............................................5.3-3410Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 172

Poloxamera ........................................................................5.8-5352Poloxamers .........................................................................5.8-5352Polyacrylate dispersion 30 per cent.....................................2265Polyacrylatis dispersio 30 per centum ..............................2265Poly(alcohol vinylicus) ..........................................................2272Polyamide 6/6 suture, sterile, in distributor for veterinaryuse .............................................................................................. 887

Polyamide 6 suture, sterile, in distributor for veterinary use..................................................................................................... 886

Polyethyleneglycols .................................................................1950



Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 298

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use .......................................................................... 887

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 285

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 279

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 278

Polygalae radix ........................................................................ 2401Polygoni avicularis herba .....................................................1877Polymorphism (5.9.) .................................................................. 555Polymyxin B sulphate ......................................................5.7-5094Polymyxini B sulfas.........................................................5.7-5094Polyolefines (3.1.3.) ................................................................... 274Polyoxyl castor oil.............................................................5.3-3547Polyoxyl hydrogenated castor oil ..................................5.2-3231Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 282

Polysaccharide vaccines, hexosamines in (2.5.20.)............. 132Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 133Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 132Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 132Polysaccharide vaccines, phosphorus in (2.5.18.)............... 132Polysaccharide vaccines, protein in (2.5.16.) ........................131Polysaccharide vaccines, ribose in (2.5.31.) ......................... 137Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 133Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 133Polysorbate 20 ..........................................................................2267Polysorbate 40 ..........................................................................2268Polysorbate 60 ..........................................................................2269Polysorbate 80 ...................................................................5.4-4007Polysorbatum 20 .....................................................................2267Polysorbatum 40 .....................................................................2268Polysorbatum 60 .....................................................................2269Polysorbatum 80 ..............................................................5.4-4007Poly(vinyl acetate)....................................................................2271Poly(vinyl acetate) dispersion 30 per cent ..................5.8-5353Poly(vinyl alcohol) ...................................................................2272Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)....................................................................................... 291

Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 289

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ..............311

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 296

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 269

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 272

Poly (vinyl chloride), plasticised, sterile containers offor human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312

Poly(vinylis acetas) .................................................................2271Poly(vinylis acetas) dispersio 30 per centum ...........5.8-5353Poppy petals, red......................................................................2359Porcine actinobacillosis vaccine (inactivated) ..................... 784Porcine influenza vaccine (inactivated) ................................ 785Porcine insulin..........................................................................1806Porcine parvovirosis vaccine (inactivated) ........................... 787Porcine progressive atrophic rhinitis vaccine(inactivated) .............................................................................. 788

Porosity of sintered-glass filters (2.1.2.) ...................................17Potassium (2.4.12.) .................................................................... 108Potassium acetate ....................................................................2273Potassium bromide ..................................................................2273Potassium carbonate............................................................... 2274Potassium chloride ...........................................................5.2-3261Potassium citrate .....................................................................2275Potassium clavulanate ............................................................ 2276Potassium clavulanate, diluted .............................................2278Potassium dihydrogen phosphate ........................................2280Potassium hydrogen aspartate hemihydrate .....................2280Potassium hydrogen carbonate ............................................ 2281Potassium hydrogen tartrate.................................................2282Potassium hydroxide ...............................................................2283Potassium iodide......................................................................2283Potassium metabisulphite...............................................5.3-3597Potassium nitrate .....................................................................2284Potassium perchlorate ............................................................2285Potassium permanganate.......................................................2286Potassium sodium tartrate tetrahydrate.............................2286Potassium sorbate....................................................................2287Potassium sulphate .................................................................2288Potato starch.............................................................................2288Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 55

Potentiometric determination of pH (2.2.3.).......................... 26Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathicstocks and.........................................................................5.8-5260

Poultices..............................................................................5.5-4165Pour-on preparations ................................................................ 631Povidone .............................................................................5.7-5096Povidone, iodinated ................................................................. 2291Povidonum.........................................................................5.7-5096Povidonum iodinatum ........................................................... 2291Powdered cellulose ...........................................................5.7-4989Powder flow (2.9.36.) .......................................................5.3-3363Powders and granules for oral solutions andsuspensions......................................................................5.6-4472

Powders and granules for syrups ..................................5.6-4472Powders and tablets for rectal solutions andsuspensions......................................................................5.5-4163

Powders, ear.......................................................................5.5-4157Powders, effervescent.......................................................5.2-3148Powders for cutaneous application...............................5.2-3147Powders for eye drops and powders for eye lotions ..5.5-4159Powders for inhalation.....................................................5.1-2845Powders for injections or infusions ..............................5.2-3145Powders for oral drops.....................................................5.6-4472Powders, nasal ...................................................................5.6-4474Powders, oral .....................................................................5.2-3147Poxvirus vectors for human use ....................................5.6-4464Praeadmixta ad alimenta medicataad usum veterinarium ............................................................617

Praeparationes ad irrigationem...................................5.6-4474Praeparationes buccales ................................................5.4-3844Praeparationes homoeopathicas .................................5.8-5259Praeparationes insulini iniectabiles ...........................5.4-3957Praeparationes intramammariaead usum veterinarium ........................................................... 606

Praeparationes intraruminales .................................... 5.2-3141Praeparationes intra-uterinae ad usum veterinarium ....5.3-3397

Praeparationes liquidae ad usum dermicum ...........5.5-4159Praeparationes liquidae peroraliae.............................5.6-4471Praeparationes liquidae veterinariae ad usum dermicum..................................................................................................... 630

Praeparationes molles ad usum dermicum ..............5.5-4164Praeparationes pharmaceuticae in vasis cum pressu..... 622



Pravastatin sodium...........................................................5.8-5355Pravastatinum natricum ................................................5.8-5355Prazepam ...................................................................................2293Prazepamum ............................................................................2293Praziquantel ..............................................................................2294Praziquantelum .......................................................................2294Prazosin hydrochloride ..........................................................2295Prazosini hydrochloridum ...................................................2295Prednicarbate............................................................................2297Prednicarbatum.......................................................................2297Prednisolone .............................................................................2298Prednisolone acetate........................................................5.6-4664Prednisolone pivalate.............................................................. 2301Prednisolone sodium phosphate ..........................................2302Prednisoloni acetas .........................................................5.6-4664Prednisoloni natrii phosphas ..............................................2302Prednisoloni pivalas............................................................... 2301Prednisolonum ........................................................................2298Prednisone.................................................................................2303Prednisonum ............................................................................2303Prekallikrein activator (2.6.15.) .....................................5.5-4111Premixes for medicated feeding stuffs for veterinary use ..617Preparations for inhalation.............................................5.1-2843Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ............................................................5.2-3103

Preparations for irrigation..............................................5.6-4474Pressurised pharmaceutical preparations ............................ 622Prilocaine...................................................................................2305Prilocaine hydrochloride........................................................2307Prilocaini hydrochloridum...................................................2307Prilocainum..............................................................................2305Primaquine diphosphate ........................................................2308Primaquini diphosphas .........................................................2308Primary aromatic amino-nitrogen, determination of(2.5.8.) ........................................................................................ 129

Primary standards for volumetric solutions (4.2.1.) ..5.7-4937Primidone ..................................................................................2309Primidonum .............................................................................2309Primulae radix ......................................................................... 2310Primula root .............................................................................. 2310Probenecid................................................................................. 2311Probenecidum .......................................................................... 2311Procainamide hydrochloride ................................................. 2312Procainamidi hydrochloridum............................................ 2312Procaine benzylpenicillin ....................................................... 1080Procaine hydrochloride .......................................................... 2312Procaini hydrochloridum ..................................................... 2312Prochlorperazine maleate ...................................................... 2313Prochlorperazini maleas....................................................... 2313Producta ab ADN recombinante ..................................5.8-5227Producta ab fermentatione ..................................................... 576Producta allergenica .......................................................5.8-5217Producta cum possibili transmissione vectoriumenkephalopathiarum spongiformium animalium ......... 577

Products of fermentation ......................................................... 576Products of recombinant DNA technology .................5.8-5227Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 577

Progesterone ............................................................................. 2314Progesteronum ........................................................................ 2314Proguanil hydrochloride ........................................................ 2315Proguanili hydrochloridum ................................................. 2315Proline ........................................................................................ 2316Prolinum ................................................................................... 2316Promazine hydrochloride....................................................... 2317Promazini hydrochloridum.................................................. 2317Promethazine hydrochloride................................................. 2318Promethazini hydrochloridum............................................ 2318Propacetamol hydrochloride ................................................. 2319

Propacetamoli hydrochloridum .......................................... 2319Propafenone hydrochloride ............................................5.1-2996Propafenoni hydrochloridum .......................................5.1-2996Propanol.....................................................................................2320Propanol and methanol, test for, 2-, (2.9.11.) .............5.3-3362Propanolum..............................................................................2320Propantheline bromide........................................................... 2321Propanthelini bromidum ...................................................... 2321Propofol...............................................................................5.4-4008Propofolum ........................................................................5.4-4008Propranolol hydrochloride..............................................5.8-5356Propranololi hydrochloridum.......................................5.8-5356Propylene glycol.......................................................................2327Propylene glycol dicaprylocaprate.......................................2327Propylene glycol dilaurate .....................................................2328Propylene glycol monolaurate ..............................................2329Propylene glycol monopalmitostearate...............................2330Propylene glycol monostearate.............................................2330Propylenglycoli dicaprylocapras ........................................2327Propylenglycoli dilauras .......................................................2328Propylenglycoli monolauras ................................................2329Propylenglycoli monopalmitostearas ................................2330Propylenglycolum ...................................................................2327Propyl gallate ............................................................................2325Propylis gallas..........................................................................2325Propylis parahydroxybenzoas .............................................2326Propylis parahydroxybenzoas natricum ..........................2448Propyl parahydroxybenzoate.................................................2326Propylthiouracil ....................................................................... 2331Propylthiouracilum ................................................................ 2331Propyphenazone ......................................................................2332Propyphenazonum .................................................................2332Protamine hydrochloride .......................................................2332Protamine sulphate .................................................................2334Protamini hydrochloridum ..................................................2332Protamini sulfas ......................................................................2334Protein in polysaccharide vaccines (2.5.16.) .........................131Protein, total (2.5.33.) ............................................................... 138Prothrombin complex, human .............................................. 1748Prothrombinum multiplex humanum ............................... 1748Protirelin ....................................................................................2335Protirelinum .............................................................................2335Proxyphylline ............................................................................2336Proxyphyllinum.......................................................................2336Pruni africanae cortex ..........................................................2339Pseudoephedrine hydrochloride ..........................................2337Pseudoephedrini hydrochloridum .....................................2337Psyllii semen ............................................................................2338Psyllium seed ............................................................................2338Pulveres ad usum dermicum ........................................5.2-3147Pulveres perorales............................................................5.2-3147Purified water ...........................................................................2697Purified water, highly .............................................................2695Purple coneflower herb...................................................5.7-5098Purple coneflower root....................................................5.7-5100Pycnometric density of solids (2.9.23.) ................................. 257Pygeum africanum bark .........................................................2339Pyrantel embonate...................................................................2339Pyranteli embonas ..................................................................2339Pyrazinamide ............................................................................2340Pyrazinamidum.......................................................................2340Pyridostigmine bromide ......................................................... 2341Pyridostigmini bromidum .................................................... 2341Pyridoxine hydrochloride.......................................................2342Pyridoxini hydrochloridum .................................................2342Pyrimethamine .........................................................................2343Pyrimethaminum ....................................................................2343Pyrogens (2.6.8.)......................................................................... 152Pyrrolidone.........................................................................5.7-5102



Pyrrolidonum....................................................................5.7-5102

QQuality of pharmaceutical preparations, microbiological(5.1.4.)................................................................................5.6-4451

Quantified hawthorn leaf and flower liquid extract ..5.3-3511Quercus cortex ......................................................................... 2129Quinidine sulphate ..................................................................2347Quinine hydrochloride............................................................2348Quinine sulphate......................................................................2350

RRabies immunoglobulin, human .......................................... 1750Rabies vaccine for human use prepared in cellcultures .............................................................................5.8-5245

Rabies vaccine (inactivated) for veterinary use................... 790Rabies vaccine (live, oral) for foxes ........................................ 792Racemic camphor..................................................................... 1172Racemic ephedrine hydrochloride .......................................1509Racemic menthol ..................................................................... 1991Raclopride ([11C]methoxy) injection....................................... 838Raclopridi ([11C]methoxy) solutio iniectabilis ................... 838Radionuclides, table of physical characteristics (5.7.) ....... 539Radiopharmaceutica ................................................................ 578Radiopharmaceutical preparations ........................................ 578Radiopharmaceutical preparations, iobenguane sulphatefor .......................................................................................5.8-5255

Raman spectrometry (2.2.48.) ................................................... 79Ramipril......................................................................................2355Ramiprilum ..............................................................................2355Ramon assay, flocculation value (Lf) of diphtheria andtetanus toxins and toxoids (2.7.27.) ............................5.6-4424

Ranitidine hydrochloride.................................................5.3-3601Ranitidini hydrochloridum ...........................................5.3-3601Rapae oleum raffinatum .......................................................2359Rapeseed oil, refined...............................................................2359Ratanhiae radix .......................................................................2362Ratanhiae tinctura ..................................................................2362Reagents (4.1.1.) ................................................................5.7-4817Reagents (4.1.1.) ................................................................5.8-5209Reagents (4.) ......................................................................5.7-4817Reagents, standard solutions, buffer solutions(4.1.) ...................................................................................5.7-4817

Recombinant DNA technology, products of................5.8-5227Rectal capsules ..................................................................5.5-4163Rectal foams.......................................................................5.5-4164Rectalia ...............................................................................5.5-4162Rectal preparations...........................................................5.5-4162Rectal preparations, semi-solid ......................................5.5-4164Rectal solutions and suspensions, powders and tabletsfor .......................................................................................5.5-4162

Rectal solutions, emulsions and suspensions.............5.5-4163Rectal tampons..................................................................5.5-4164Red poppy petals......................................................................2359Reference standards (5.12.) ............................................5.6-4455Refractive index (2.2.6.) .............................................................. 28Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 27

Relative density (2.2.5.)............................................................... 27Repaglinide.........................................................................5.2-3267Repaglinidum....................................................................5.2-3267Reserpine ...................................................................................2360Reserpinum ..............................................................................2360Residual solvents (5.4.) ............................................................. 507Residual solvents, identification and control (2.4.24.) ...... 113Residue on evaporation of essential oils (2.8.9.)..................216Resistance to crushing of tablets (2.9.8.) ............................. 235

Resistance to rupture of suppositories and pessaries(2.9.24.) ...................................................................................... 258

Resorcinol ..................................................................................2360Resorcinolum ...........................................................................2360Restharrow root ....................................................................... 2361Rhamni purshianae cortex................................................... 1194Rhamni purshianae extractum siccumnormatum ..5.6-4542Rhatany root .............................................................................2362Rhatany tincture ......................................................................2362Rhei radix..................................................................................2363Rhenii sulfidi colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 851

Rhinotracheitis vaccine (inactivated), viral, feline .....5.7-4951Rhinotracheitis vaccine (live), viral, feline...................5.7-4952Rhubarb .....................................................................................2363Ribavirin..............................................................................5.1-3002Ribavirinum ......................................................................5.1-3002Riboflavin...................................................................................2365Riboflavini natrii phosphas ..........................................5.6-4675Riboflavin sodium phosphate.........................................5.6-4675Riboflavinum............................................................................2365Ribose in polysaccharide vaccines (2.5.31.) ......................... 137Ribwort plantain ......................................................................2368Rice starch.................................................................................2369Ricini oleum hydrogenatum .........................................5.8-5289Ricini oleum raffinatum.................................................5.8-5290Ricini oleum virginale ........................................................... 1197Rifabutin ....................................................................................2369Rifabutinum..............................................................................2369Rifampicin..................................................................................2371Rifampicinum ..........................................................................2371Rifamycin sodium.....................................................................2372Rifamycinum natricum .........................................................2372Rilmenidine dihydrogen phosphate .....................................2373Rilmenidini dihydrogenophosphas....................................2373Risperidone ........................................................................5.3-3602Risperidonum ...................................................................5.3-3602Rocuronii bromidum.......................................................5.4-4013Rocuronium bromide .......................................................5.4-4013Roman chamomile flower ......................................................1245Rosae pseudo-fructus ............................................................. 1472Roselle ........................................................................................ 2376Rosemary leaf ...........................................................................2377Rosemary oil .............................................................................2378Rosmarini aetheroleum.........................................................2378Rosmarini folium ....................................................................2377Rotating viscometer method - viscosity (2.2.10.) .......5.3-3337Rotation, optical (2.2.7.) ..................................................5.6-4383Roxithromycin...........................................................................2379Roxithromycinum ...................................................................2379RRR-α-Tocopherol ............................................................5.6-4690RRR-α-Tocopherolum .....................................................5.6-4690RRR-α-Tocopheryl acetate ..............................................5.6-4692RRR-α-Tocopheryl hydrogen succinate .......................5.6-4697RRR-α-Tocopherylis acetas ...........................................5.6-4692RRR-α-Tocopherylis hydrogenosuccinas...................5.6-4697Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) .........................................................................................316

Rubella immunoglobulin, human......................................... 1751Rubella vaccine (live) ................................................................ 701Rusci rhizoma...................................................................5.3-3454Rutoside trihydrate.................................................................. 2381Rutosidum trihydricum ......................................................... 2381

SSabalis serrulatae fructus .....................................................2398Saccharin ............................................................................5.3-3607Saccharin sodium .............................................................5.3-3608



Saccharinum .....................................................................5.3-3607Saccharinum natricum ..................................................5.3-3608Sacchari spheri........................................................................2503Saccharum .........................................................................5.5-4299Safety, viral (5.1.7.) ...........................................................5.8-5213Safflower oil, refined...............................................................2389Saffron for homoeopathic preparations................................ 900Sage leaf (salvia officinalis)....................................................2389Sage leaf, three-lobed..............................................................2390Sage tincture............................................................................. 2391Salbutamol .........................................................................5.3-3609Salbutamoli sulfas ..........................................................5.3-3611Salbutamol sulphate ........................................................5.3-3611Salbutamolum ...................................................................5.3-3609Salicis cortex ............................................................................2702Salicylic acid.......................................................................5.1-3007Salmeteroli xinafoas .......................................................5.2-3271Salmeterol xinafoate.........................................................5.2-3271Salmonella Enteritidis vaccine (inactivated) forchickens ............................................................................5.8-5249

Salmonella Typhimurium vaccine (inactivated) forchickens ............................................................................5.8-5250

Salmonis domestici oleum ...................................................2396Salmon oil, farmed...................................................................2396Salviae officinalis folium ......................................................2389Salviae sclareae aetheroleum .............................................. 1311Salviae tinctura ....................................................................... 2391Salviae trilobae folium ..........................................................2390Sambuci flos ............................................................................. 1496Saponification value (2.5.6.) .................................................... 129Saw palmetto fruit ...................................................................2398Scopolamine.......................................................................5.3-3519Scopolamine butylbromide .................................................... 1776Scopolamine hydrobromide................................................... 1777Scopolamini butylbromidum ............................................... 1776Scopolamini hydrobromidum.............................................. 1777Scopolaminum..................................................................5.3-3519Selegiline hydrochloride ........................................................2400Selegilini hydrochloridum....................................................2400Selenii disulfidum................................................................... 2401Selenium disulphide................................................................ 2401Semecarpus anacardiumad praeparationes homoeopathicas..........................5.3-3430

Semi-micro determination of water (2.5.12.) ..............5.7-4785Semi-solid and liquid preparations, test for deliverable massor volume (2.9.28.) .................................................................. 263

Semi-solid ear preparations ............................................5.5-4157Semi-solid eye preparations ............................................5.5-4159Semi-solid intrauterine preparations ............................5.3-3397Semi-solid nasal preparations.........................................5.6-4474Semi-solid oromucosal preparations.............................5.4-3845Semi-solid preparations for cutaneous application ...5.5-4164Semi-solid rectal preparations........................................5.5-4164Semi-solid vaginal preparations.....................................5.5-4169Senega root ............................................................................... 2401Sennae folii extractum siccum normatum.......................2403Sennae folium..........................................................................2402Sennae fructus acutifoliae....................................................2404Sennae fructus angustifoliae ...............................................2405Senna leaf ..................................................................................2402Senna leaf dry extract, standardised ...................................2403Senna pods, Alexandrian........................................................2404Senna pods, Tinnevelly ...........................................................2405Separation techniques, chromatographic (2.2.46.) .............. 69Serine..........................................................................................2406Serinum .....................................................................................2406Serpylli herba........................................................................... 2701Sertaconazole nitrate..............................................................2407Sertaconazoli nitras ...............................................................2407

Serum bovinum ................................................................5.4-3903Sesame oil, refined ...........................................................5.8-5361Sesami oleum raffinatum ..............................................5.8-5361Sets for the transfusion of blood and blood components(3.2.6.) .........................................................................................313

Shampoos ...........................................................................5.5-4160Shellac .......................................................................................2409Sialic acid in polysaccharide vaccines (2.5.23.)................... 133Siam benzoin .....................................................................5.2-3175Siam benzoin tincture......................................................5.4-3902Sieves (2.1.4.) .................................................................................18Sieve test (2.9.12.)...................................................................... 239Sieving, analytical, particle-size distribution estimation by(2.9.38.) .............................................................................5.3-3368

SI (International System) units (1.) ..............................5.6-4373Silica ad usum dentalem....................................................... 2411Silica, colloidal anhydrous ..................................................... 2410Silica, colloidal hydrated ........................................................ 2411Silica colloidalis anhydrica.................................................. 2410Silica colloidalis hydrica....................................................... 2411Silica, dental type..................................................................... 2411Silica hydrophobica colloidalis anhydrica ...............5.8-5362Silica, hydrophobic colloidal anhydrous......................5.8-5362Silicone elastomer for closures and tubing (3.1.9.) ............ 288Silicone oil used as a lubricant (3.1.8.) ................................. 287Silk suture, sterile, braided, in distributor for veterinary use..................................................................................................... 887

Silver, colloidal, for external use ...................................5.3-3613Silver nitrate ............................................................................. 2412Silybi mariani extractum siccum raffinatum etnormatum ........................................................................5.6-4635

Silybi mariani fructus.....................................................5.7-5055Simeticone ................................................................................. 2412Simeticonum ............................................................................ 2412Simvastatin................................................................................ 2413Simvastatinum ......................................................................... 2413Single-dose preparations, uniformity of content (2.9.6.)... 234Single-dose preparations, uniformity of mass (2.9.5.)........ 233Sintered-glass filters (2.1.2.) .......................................................17Size-exclusion chromatography (2.2.30.)................................ 45(S)-Lactic acid.....................................................................5.2-3227Smallpox vaccine (live) ....................................................5.4-3873Sodium acetate ([1-11C]) injection..................................5.4-3885Sodium acetate trihydrate ..................................................... 2415Sodium alendronate ................................................................ 2416Sodium alginate ....................................................................... 2417Sodium amidotrizoate............................................................. 2418Sodium aminosalicylate dihydrate ....................................... 2419Sodium ascorbate .............................................................5.6-4679Sodium aurothiomalate ...................................................5.8-5363Sodium benzoate ..................................................................... 2421Sodium bromide.......................................................................2422Sodium calcium edetate ..................................................5.7-5107Sodium caprylate .....................................................................2423Sodium carbonate, anhydrous .......................................5.1-3008Sodium carbonate decahydrate .....................................5.1-3008Sodium carbonate monohydrate ...................................5.1-3009Sodium carboxymethylcellulose ........................................... 1189Sodium carboxymethylcellulose, cross-linked ............5.7-5000Sodium carboxymethylcellulose, low-substituted............. 1190Sodium cetostearyl sulphate .................................................2426Sodium chloride .......................................................................2428Sodium chromate (51Cr) sterile solution ............................... 840Sodium citrate ..........................................................................2429Sodium cromoglicate ..............................................................2429Sodium cyclamate....................................................................2430Sodium dihydrogen phosphate dihydrate .......................... 2431Sodium fluoride .......................................................................2432Sodium fluoride (18F) injection ............................................... 841



Sodium fusidate .......................................................................2433Sodium glycerophosphate, hydrated ...................................2434Sodium hyaluronate ................................................................2434Sodium hydrogen carbonate .................................................2437Sodium hydroxide....................................................................2437Sodium iodide...........................................................................2438Sodium iodide (123I) injection .................................................. 842Sodium iodide (123I) solution for radiolabelling .........5.5-4181Sodium iodide (131I) capsules for diagnostic use................. 843Sodium iodide (131I) capsules for therapeutic use .....5.2-3157Sodium iodide (131I) solution ................................................... 844Sodium iodide (131I) solution for radiolabelling .................. 845Sodium iodohippurate (123I) injection ................................... 845Sodium iodohippurate (131I) injection ................................... 846Sodium lactate solution..........................................................2438Sodium laurilsulfate ................................................................2440Sodium metabisulphite........................................................... 2441Sodium methyl parahydroxybenzoate................................. 2441Sodium molybdate (99Mo) solution (fission) ...............5.7-4959Sodium molybdate dihydrate ................................................2442Sodium nitrite...........................................................................2443Sodium nitroprusside .............................................................2443Sodium perborate, hydrated..................................................2444Sodium pertechnetate (99mTc) injection (fission) ................ 847Sodium pertechnetate (99mTc) injection (non-fission) ........ 848Sodium phosphate (32P) injection .......................................... 849Sodium picosulfate .................................................................2445Sodium polystyrene sulphonate ...........................................2446Sodium propionate ..................................................................2447Sodium propyl parahydroxybenzoate..................................2448Sodium salicylate .....................................................................2449Sodium selenite pentahydrate .......................................5.4-4018Sodium (S)-lactate solution ...................................................2439Sodium starch glycolate (type A) ..................................5.4-4018Sodium starch glycolate (type B) ..................................5.4-4019Sodium starch glycolate (type C) ......................................... 2451Sodium stearate ................................................................5.7-5108Sodium stearyl fumarate ........................................................2453Sodium sulphate, anhydrous.................................................2454Sodium sulphate decahydrate...............................................2455Sodium sulphite, anhydrous...........................................5.6-4679Sodium sulphite heptahydrate.......................................5.6-4680Sodium thiosulphate........................................................5.1-3009Sodium valproate .....................................................................2457Soft capsules ......................................................................5.5-4155Softening time determination of lipophilic suppositories(2.9.22.) ...................................................................................... 256

Soft extracts .......................................................................5.8-5222Soiae oleum hydrogenatum .................................................2475Soiae oleum raffinatum ........................................................ 2476Solani amylum ........................................................................2288Solidaginis herba .............................................................5.2-3213Solidaginis virgaureae herba........................................5.3-3507Solid dosage forms, dissolution test for (2.9.3.) .........5.7-4805Solids, density of (2.2.42.) .......................................................... 64Solids, pycnometric density of (2.9.23.) ................................ 257Solubility in alcohol of essential oils (2.8.10.) ......................216Soluble tablets ...................................................................5.8-5240Solutiones ad conservationem partium corporis ...........2458Solutiones ad haemocolaturamhaemodiacolaturamque ...................................................... 1703

Solutiones ad haemodialysim ............................................. 1700Solutiones ad peritonealem dialysim ................................ 2212Solutiones anticoagulantes et sanguinem humanumconservantes .......................................................................... 1007

Solutions, emulsions and suspensions, oral ...............5.6-4471Solutions for haemodialysis................................................... 1700Solutions for haemodialysis, concentrated, water fordiluting..................................................................................... 1699

Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................ 1703

Solutions for organ preservation..........................................2458Solutions for peritoneal dialysis ........................................... 2212Solutions, suspensions, intrauterine ............................5.3-3397Solvents, residual (5.4.) ............................................................ 507Solvents, residual, identification and control (2.4.24.) ...... 113Somatostatin ......................................................................5.8-5364Somatostatinum ...............................................................5.8-5364Somatropin.........................................................................5.8-5365Somatropin concentrated solution ...............................5.8-5367Somatropin for injection .................................................5.8-5369Somatropini solutio concentrata .................................5.8-5367Somatropinum ..................................................................5.8-5365Somatropinum ad iniectabilium..................................5.8-5369Sorbic acid.................................................................................2467Sorbitani lauras .......................................................................2467Sorbitani oleas .........................................................................2468Sorbitani palmitas ..................................................................2468Sorbitani sesquioleas .............................................................2468Sorbitani stearas .....................................................................2469Sorbitani trioleas ....................................................................2469Sorbitan laurate .......................................................................2467Sorbitan oleate .........................................................................2468Sorbitan palmitate ...................................................................2468Sorbitan sesquioleate..............................................................2468Sorbitan stearate......................................................................2469Sorbitan trioleate .....................................................................2469Sorbitol.......................................................................................2470Sorbitol, liquid (crystallising)................................................2471Sorbitol, liquid (non-crystallising)........................................2472Sorbitol, liquid, partially dehydrated...................................2473Sorbitolum ................................................................................2470Sorbitolum liquidum cristallisabile....................................2471Sorbitolum liquidum non cristallisabile ...........................2472Sorbitolum liquidum partim deshydricum ......................2473Sotalol hydrochloride ............................................................. 2474Sotaloli hydrochloridum ....................................................... 2474Soya-bean oil, hydrogenated..................................................2475Soya-bean oil, refined.............................................................. 2476Specific surface area by air permeability (2.9.14.).............. 239Specific surface area by gas adsorption (2.9.26.) ......5.1-2811Spectinomycin dihydrochloride pentahydrate ...........5.7-5109Spectinomycin hydrochloride.........................................5.4-4020Spectinomycini dihydrochloridum pentahydricum ........5.7-5109

Spectinomycini sulfas tetrahydricus ad usumveterinarium ................................................................... 5.7-5111

Spectinomycin sulphate tetrahydrate for veterinary use ..5.7-5111

Spectrometry, atomic absorption (2.2.23.) ............................. 36Spectrometry, atomic emission (2.2.22.)................................. 35Spectrometry, mass (2.2.43.) ..................................................... 65Spectrometry, nuclear magnetic resonance (2.2.33.) ...........51Spectrometry, Raman (2.2.48.) ................................................. 79Spectrometry, X-ray fluorescence (2.2.37.)............................. 56Spectrophotometry, infrared absorption (2.2.24.)................ 37Spectrophotometry, near-infrared (2.2.40.)............................ 59Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .............................................................................5.6-4383

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) ...............................................................5.1-2825

Spiramycin..........................................................................5.1-3010Spiramycinum ..................................................................5.1-3010Spirapril hydrochloride monohydrate.................................2480Spiraprili hydrochloridum monohydricum .....................2480Spironolactone .........................................................................2482Spironolactonum ....................................................................2482Spot-on preparations................................................................. 631



Sprays ........................................................................................... 631Sprays (liquid nasal) and drops (nasal) ........................5.6-4473Squalane ....................................................................................2483Squalanum................................................................................2483Standard solutions for limit tests (4.1.2.) ....................5.7-4928Standard solutions for limit tests (4.1.2.) ....................5.8-5209Standards, reference (5.12.)............................................5.6-4455Stanni colloidalis et technetii (99mTc)solutio iniectabilis .................................................................. 853

Stanni pyrophosphatis et technetii (99mTc) solutioiniectabilis ................................................................................ 865

Stannosi chloridum dihydricum..................................5.6-4681Stannous chloride dihydrate ..........................................5.6-4681Stanozolol..................................................................................2486Stanozololum ...........................................................................2486Star anise ............................................................................5.5-4297Star anise oil .............................................................................2488Starch glycolate (type A), sodium .................................5.4-4018Starch glycolate (type B), sodium .................................5.4-4019Starch glycolate (type C), sodium ........................................ 2451Starch, maize .....................................................................5.1-2965Starch, potato ...........................................................................2288Starch, pregelatinised .............................................................2490Starch, rice ................................................................................2369Starch, wheat ............................................................................2698Statistical analysis of results of biological assays and tests(5.3.)............................................................................................ 475

Stavudine............................................................................5.1-3012Stavudinum .......................................................................5.1-3012Steam sterilisation of aqueous preparations, application ofthe F0 concept (5.1.5.)....................................................5.1-2821

Stearic acid.........................................................................5.6-4681Stearoyl macrogolglycerides ..........................................5.2-3274Stearyl alcohol...................................................................5.3-3621Stem cells, human haematopoietic ...............................5.6-4598Sterile braided silk suture in distributor for veterinaryuse............................................................................................... 887

Sterile catgut............................................................................... 873Sterile catgut in distributor for veterinary use ................... 885Sterile containers of plasticised poly (vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 312

Sterile linen thread in distributor for veterinary use......... 886Sterile non-absorbable strands in distributor for veterinaryuse............................................................................................... 888

Sterile non-absorbable sutures ......................................5.3-3423Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 309

Sterile polyamide 6/6 suture in distributor for veterinaryuse............................................................................................... 887

Sterile polyamide 6 suture in distributor for veterinaryuse............................................................................................... 886

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use ........................................................................... 887

Sterile products, methods of preparation (5.1.1.) ............... 445Sterile single-use plastic syringes (3.2.8.) ..............................314Sterile synthetic absorbable braided sutures ...................... 878Sterile synthetic absorbable monofilament sutures........... 880Sterilisation procedures, biological indicators (5.1.2.) ...... 447Sterility (2.6.1.) ........................................................................... 145Sterols in fatty oils (2.4.23.)............................................5.1-2787Sticks ............................................................................................ 626Sticks, intrauterine ...........................................................5.3-3397Sticks, nasal........................................................................5.6-4474St. John’s wort..........................................................................2485Stomata and stomatal index (2.8.3.) ...................................... 215Stramonii folium .....................................................................2492Stramonii pulvis normatus...................................................2494Stramonium leaf.......................................................................2492

Stramonium, prepared ............................................................2494Strands, sterile non-absorbable, in distributor for veterinaryuse .............................................................................................. 888

Streptokinase bulk solution ...........................................5.3-3622Streptokinasi solutio ad praeparationem ..................5.3-3622Streptomycini sulfas...............................................................2496Streptomycin sulphate ............................................................2496Strontii (89Sr) chloridi solutio iniectabilis .......................... 850Strontium (89Sr) chloride injection ........................................ 850Styli ............................................................................................... 626Subdivision of tablets.......................................................5.8-5239Sublingual sprays, oromucosal drops and oromucosalsprays.................................................................................5.4-3844

Sublingual tablets and buccal tablets ..........................5.4-3847Substances for pharmaceutical use ..............................5.8-5229Substances for pharmaceutical use, control of impurities in(5.10.).................................................................................5.5-4145

Substances of animal origin for the production of veterinaryvaccines (5.2.5.) ........................................................................ 460

Sub-visible particles, particulate contamination (2.9.19.) .. 253Succinylsulfathiazole ..............................................................2498Succinylsulfathiazolum .........................................................2498Sucrose................................................................................5.5-4299Sufentanil .................................................................................. 2501Sufentanil citrate .....................................................................2502Sufentanili citras .....................................................................2502Sufentanilum............................................................................ 2501Sugars, lead in (2.4.10.) ............................................................ 107Sugar spheres ...........................................................................2503Sulbactam sodium ............................................................5.8-5372Sulbactamum natricum..................................................5.8-5372Sulfacetamide sodium.............................................................2504Sulfacetamidum natricum ....................................................2504Sulfadiazine...............................................................................2505Sulfadiazinum .........................................................................2505Sulfadimidine............................................................................2506Sulfadimidinum.......................................................................2506Sulfadoxine................................................................................2507Sulfadoxinum...........................................................................2507Sulfafurazole.............................................................................2508Sulfafurazolum ........................................................................2508Sulfaguanidine...................................................................5.5-4302Sulfaguanidinum .............................................................5.5-4302Sulfamerazine ...........................................................................2509Sulfamerazinum......................................................................2509Sulfamethizole.......................................................................... 2510Sulfamethizolum ..................................................................... 2510Sulfamethoxazole .............................................................5.3-3623Sulfamethoxazolum.........................................................5.3-3623Sulfamethoxypyridazine for veterinary use ....................... 2512Sulfamethoxypyridazinum ad usum veterinarium ....... 2512Sulfanilamide ............................................................................ 2513Sulfanilamidum....................................................................... 2513Sulfasalazine ............................................................................. 2514Sulfasalazinum ........................................................................ 2514Sulfathiazole ............................................................................. 2516Sulfathiazolum ........................................................................ 2516Sulfinpyrazone ......................................................................... 2517Sulfinpyrazonum .................................................................... 2517Sulfisomidine ............................................................................ 2518Sulfisomidinum ....................................................................... 2518Sulfur ad usum externum .....................................................2520Sulfuris colloidalis et technetii (99mTc) solutioiniectabilis ................................................................................ 852

Sulindac ..................................................................................... 2518Sulindacum .............................................................................. 2518Sulphated ash (2.4.14.) ....................................................5.6-4389Sulphates (2.4.13.) ..................................................................... 108Sulphur dioxide (2.5.29.).......................................................... 136



Sulphur for external use ........................................................2520Sulphuric acid...........................................................................2520Sulpiride..................................................................................... 2521Sulpiridum ................................................................................ 2521Sultamicillin .......................................................................5.7-5113Sultamicillini tosilas dihydricus ..................................5.7-5115Sultamicillin tosilate dihydrate......................................5.7-5115Sultamicillinum................................................................5.7-5113Sumatra benzoin...............................................................5.6-4519Sumatra benzoin tincture ...............................................5.6-4520Sumatriptani succinas....................................................5.5-4303Sumatriptan succinate.....................................................5.5-4303Sunflower oil, refined .............................................................2524Supercritical fluid chromatography (2.2.45.) ........................ 68Suppositories .....................................................................5.5-4163Suppositories and pessaries, disintegration of (2.9.2.)...... 227Suppositories and pessaries, resistance to rupture(2.9.24.) ...................................................................................... 258

Suppositories, lipophilic, softening time determination(2.9.22.) ...................................................................................... 256

Suspensions, solutions and emulsions, oral ...............5.6-4471Suspensions, solutions, intrauterine ............................5.3-3397Sutures, sterile non-absorbable .....................................5.3-3423Sutures, sterile synthetic absorbable braided .................... 878Sutures, sterile synthetic absorbable monofilament ........ 880Suxamethonii chloridum ......................................................2525Suxamethonium chloride.......................................................2525Suxibuzone................................................................................2525Suxibuzonum ...........................................................................2525Sweet fennel..............................................................................1580Sweet orange oil.......................................................................2526Swelling index (2.8.4.)............................................................... 215Swine erysipelas vaccine (inactivated) .................................. 793Swine-fever vaccine (live), classical, freeze-dried ................ 793Symbols and abbreviations (1.) ......................................5.6-4373Synthetic absorbable braided sutures, sterile ..................... 878Synthetic absorbable monofilament sutures, sterile.......... 880Syringes, plastic, sterile single-use (3.2.8.) ............................314Syrups..................................................................................5.6-4472

TTable of physical characteristics of radionuclides mentionedin the European Pharmacopoeia (5.7.) ............................... 539

Tablets .................................................................................5.8-5239Tablets and capsules, disintegration of (2.9.1.) ..........5.3-3351Tablets, buccal ...................................................................5.4-3847Tablets, coated...................................................................5.8-5240Tablets, dispersible ...........................................................5.8-5240Tablets, effervescent .........................................................5.8-5240Tablets for intrauterine solutions and suspensions ..5.3-3397Tablets for use in the mouth ..........................................5.8-5241Tablets for vaginal solutions and suspensions ...........5.5-4169Tablets, gastro-resistant...................................................5.8-5240Tablets, intrauterine .........................................................5.3-3397Tablets, modified-release .................................................5.8-5240Tablets, orodispersible .....................................................5.8-5240Tablets, resistance to crushing (2.9.8.) ................................. 235Tablets, soluble..................................................................5.8-5240Tablets, subdivision of .....................................................5.8-5239Tablets, sublingual............................................................5.4-3847Tablets, uncoated ..............................................................5.8-5239Tablets, uncoated, friability of (2.9.7.) ..........................5.2-3103Tablets, vaginal..................................................................5.5-4169Talc.......................................................................................5.1-3017Talcum ................................................................................5.1-3017Tamoxifen citrate ..............................................................5.1-3018Tamoxifeni citras..............................................................5.1-3018Tamponae medicatae ............................................................... 628Tampons, ear......................................................................5.5-4157

Tampons, medicated ................................................................. 628Tampons, rectal .................................................................5.5-4164Tampons, vaginal, medicated .........................................5.5-4170Tamsulosin hydrochloride ..............................................5.7-5121Tamsulosini hydrochloridum .......................................5.7-5121Tanaceti parthenii herba ......................................................1592Tannic acid ................................................................................2534Tannins in herbal drugs, determination of (2.8.14.) .......... 221Tanninum .................................................................................2534Tartaric acid ..............................................................................2534Teat dips....................................................................................... 631Tea tree oil .................................................................................2534Teat sprays................................................................................... 631Technetii (99mTc) bicisati solutio iniectabilis.............5.5-4181Technetii (99mTc) et etifenini solutio iniectabilis ............... 853Technetii (99mTc) exametazimi solutio iniectabilis ........... 854Technetii (99mTc) gluconatis solutio iniectabilis................ 856Technetii (99mTc) humani albumini solutio iniectabilis .. 856Technetii (99mTc) macrosalbi suspensio iniectabilis......... 858Technetii (99mTc) medronati solutio iniectabilis................ 859Technetii (99mTc) mertiatidi solutio iniectabilis................. 860Technetii (99mTc) microsphaerarum suspensioiniectabilis ................................................................................ 861

Technetii (99mTc) pentetatis solutio iniectabilis ................. 862Technetii (99mTc) sestamibi solutio iniectabilis.................. 863Technetii (99mTc) succimeri solutio iniectabilis ................. 865Technetium (99mTc) bicisate injection ...........................5.5-4181Technetium (99mTc) colloidal rhenium sulphide injection..................................................................................................... 851

Technetium (99mTc) colloidal sulphur injection ................... 852Technetium (99mTc) colloidal tin injection ............................ 853Technetium (99mTc) etifenin injection .................................... 853Technetium (99mTc) exametazime injection .......................... 854Technetium (99mTc) gluconate injection ................................ 856Technetium (99mTc) human albumin injection ..................... 856Technetium (99mTc) macrosalb injection................................ 858Technetium (99mTc) medronate injection............................... 859Technetium (99mTc) mertiatide injection ............................... 860Technetium (99mTc) microspheres injection.......................... 861Technetium (99mTc) pentetate injection................................. 862Technetium (99mTc) sestamibi injection ................................. 863Technetium (99mTc) succimer injection.................................. 865Technetium (99mTc) tin pyrophosphate injection................. 865Temazepam.........................................................................5.7-5122Temazepamum .................................................................5.7-5122Tenosynovitis avian viral vaccine (live) ................................. 729Tenoxicam..................................................................................2537Tenoxicamum ..........................................................................2537Terazosin hydrochloride dihydrate ...............................5.8-5377Terazosini hydrochloridum dihydricum....................5.8-5377Terbinafine hydrochloride...............................................5.3-3627Terbinafini hydrochloridum .........................................5.3-3627Terbutaline sulphate ...............................................................2538Terbutalini sulfas ....................................................................2538Terconazole ...............................................................................2539Terconazolum ..........................................................................2539Terebinthini aetheroleum ab pinum pinastrum ......5.6-4703Terfenadine................................................................................2540Terfenadinum...........................................................................2540Terminology used in monographs on vaccines (5.2.1.) ..... 453tert-Butylamini perindoprilum.....................................5.3-3589Test for anticomplementary activity of immunoglobulin(2.6.17.)....................................................................................... 170

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ..........................5.3-3348

Test for deliverable mass or volume of liquid and semi-solidpreparations (2.9.28.).............................................................. 263

Test for extractable volume of parenteral preparations(2.9.17.)..............................................................................5.3-3363



Test for Fc function of immunoglobulin (2.7.9.) ................. 202Test for methanol and 2-propanol (2.9.11.) .................5.3-3362Test for neurovirulence of live virus vaccines (2.6.18.) ..... 172Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 172

Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) .........5.6-4404

Testosterone..............................................................................2542Testosterone decanoate ...................................................5.8-5379Testosterone enantate.............................................................2544Testosterone isocaproate.................................................5.8-5380Testosterone propionate.........................................................2545Testosteroni decanoas.....................................................5.8-5379Testosteroni enantas ..............................................................2544Testosteroni isocaproas ..................................................5.8-5380Testosteroni propionas ..........................................................2545Testosteronum..........................................................................2542Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 169

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ....................................5.6-4424

Tetanus and diphtheria vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4480

Tetanus antitoxin for human use ........................................... 805Tetanus antitoxin for veterinary use.............................5.1-2868Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 641

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)..........................................................5.4-3851

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .....................5.6-4481

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3852

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ......................5.4-3854

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .........5.4-3856

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .........................................................5.6-4483

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3858

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................5.4-3861

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)..........................................................5.4-3864

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) ..5.4-3866

Tetanus immunoglobulin, human ........................................ 1751Tetanus vaccine (adsorbed) ..................................................... 702Tetanus vaccine (adsorbed), assay of (2.7.8.) ..............5.7-4793Tetanus vaccine for veterinary use ...............................5.6-4494Tetracaine hydrochloride .......................................................2546Tetracaini hydrochloridum ..................................................2546Tetracosactide...........................................................................2547Tetracosactidum ......................................................................2547Tetracycline ........................................................................5.5-4309Tetracycline hydrochloride .............................................5.5-4310Tetracyclini hydrochloridum ........................................5.5-4310Tetracyclinum ...................................................................5.5-4309Tetrazepam................................................................................2552Tetrazepamum .........................................................................2552Tetryzoline hydrochloride...............................................5.1-3020Tetryzolini hydrochloridum ..........................................5.1-3020Thallosi (201Tl) chloridi solutio iniectabilis......................... 867Thallous (201Tl) chloride injection........................................... 867Theobromine.............................................................................2554

Theobrominum ........................................................................2554Theophylline .............................................................................2554Theophylline-ethylenediamine ..............................................2557Theophylline-ethylenediamine hydrate ...............................2557Theophylline monohydrate....................................................2555Theophyllinum.........................................................................2554Theophyllinum et ethylenediaminum ...............................2557Theophyllinum et ethylenediaminum hydricum............2557Theophyllinum monohydricum ..........................................2555Thermal analysis (2.2.34.). ......................................................... 52Thermogravimetry (2.2.34.). ...................................................... 52Thiamazole ................................................................................2558Thiamazolum ...........................................................................2558Thiamine hydrochloride .........................................................2559Thiamine nitrate....................................................................... 2561Thiamini hydrochloridum ....................................................2559Thiamini nitras ........................................................................ 2561Thiamphenicol ..........................................................................2562Thiamphenicolum...................................................................2562Thin-layer chromatography (2.2.27.).............................5.2-3090Thioctic acid .......................................................................5.5-4312Thiomersal ..........................................................................5.1-3021Thiomersalum ...................................................................5.1-3021Thiopental sodium and sodium carbonate.........................2564Thiopentalum natricum et natrii carbonas .....................2564Thioridazine .......................................................................5.8-5381Thioridazine hydrochloride ............................................5.4-4031Thioridazini hydrochloridum .......................................5.4-4031Thioridazinum ..................................................................5.8-5381Three-lobed sage leaf...............................................................2390Threonine...................................................................................2566Threoninum..............................................................................2566Thyme ..................................................................................5.6-4687Thyme oil ..................................................................................2569Thyme, wild ............................................................................... 2701Thymi aetheroleum ................................................................2569Thymi herba ......................................................................5.6-4687Thymol........................................................................................2570Thymolum .................................................................................2570Tiabendazole .............................................................................2570Tiabendazolum ........................................................................2570Tiamulin for veterinary use ...................................................2571Tiamulin hydrogen fumarate for veterinary use ...............2573Tiamulini hydrogenofumaras ad usum veterinarium ..2573Tiamulinum ad usum veterinarium ..................................2571Tianeptine sodium ...................................................................2575Tianeptinum natricum ..........................................................2575Tiapride hydrochloride ...........................................................2577Tiapridi hydrochloridum ......................................................2577Tiaprofenic acid ........................................................................2578Tibolone ..............................................................................5.7-5124Tibolonum ..........................................................................5.7-5124Ticarcillin sodium..............................................................5.3-3628Ticarcillinum natricum ..................................................5.3-3628Tick-borne encephalitis vaccine (inactivated) .............5.3-3414Ticlopidine hydrochloride ...................................................... 2581Ticlopidini hydrochloridum ................................................. 2581Tiliae flos................................................................................... 1914Tilidine hydrochloride hemihydrate ....................................2582Tilidini hydrochloridum hemihydricum...........................2582Timololi maleas ................................................................5.7-5125Timolol maleate .................................................................5.7-5125Tincturae ............................................................................5.8-5221Tincturae maternaead praeparationes homoeopathicas................................... 894

Tinctures .............................................................................5.8-5221Tinidazole ..................................................................................2585Tinidazolum .............................................................................2585Tinnevelly senna pods.............................................................2405



Tinzaparin sodium...................................................................2586Tinzaparinum natricum .......................................................2586Tioconazole ...............................................................................2586Tioconazolum ..........................................................................2586Titanii dioxidum......................................................................2587Titanium dioxide ......................................................................2587Titration, amperometric (2.2.19.).............................................. 34Titration, potentiometric (2.2.20.) ............................................ 35Titrations, complexometric (2.5.11.) ...................................... 130Tobramycin .........................................................................5.3-3629Tobramycinum..................................................................5.3-3629Tocopherol, all-rac-α- .......................................................5.6-4688Tocopherol, RRR-α- ..........................................................5.6-4690Tocopheryl acetate, all-rac-α- .........................................5.6-4691α-Tocopheryl acetate concentrate (powder form) .....5.6-4693Tocopheryl acetate, RRR-α-............................................5.6-4692Tocopheryl hydrogen succinate, DL-α- .........................5.6-4695Tocopheryl hydrogen succinate, RRR-α- .....................5.6-4697α-Tocopherylis acetatis pulvis ......................................5.6-4693Tolbutamide ..............................................................................2600Tolbutamidum ..........................................................................2600Tolfenamic acid......................................................................... 2601Tolnaftate ..................................................................................2602Tolnaftatum ..............................................................................2602Tolu balsam ...............................................................................2603Torasemide, anhydrous....................................................5.6-4699Torasemidum anhydricum ............................................5.6-4699Tormentil ...................................................................................2604Tormentillae rhizoma ............................................................2604Tormentillae tinctura .............................................................2605Tormentil tincture....................................................................2605Tosylchloramide sodium.........................................................2605Tosylchloramidum natricum ...............................................2605Total ash (2.4.16.)....................................................................... 108Total cholesterol in oils rich in omega-3 acids(2.4.32.) .............................................................................5.8-5197

Total organic carbon in water for pharmaceutical use(2.2.44.) ........................................................................................ 68

Total protein (2.5.33.) ............................................................... 138Total viable aerobic count (microbiological examination ofnon-sterile products) (2.6.12.) ......................................5.6-4398

Toxicity, abnormal (2.6.9.)........................................................ 153Toxin, botulinum type A for injection...................................1117Toxinum botulinicum typum A ad iniectabile .................1117Tragacanth ................................................................................2606Tragacantha..............................................................................2606Tramadol hydrochloride .........................................................2607Tramadoli hydrochloridum ..................................................2607Tramazoline hydrochloride monohydrate ...................5.3-3633Tramazolini hydrochloridum monohydricum .........5.3-3633Trandolapril........................................................................5.4-4034Trandolaprilum ................................................................5.4-4034Tranexamic acid ................................................................5.8-5382Transdermal patches ........................................................5.2-3146Transdermal patches, dissolution test for (2.9.4.) .............. 231Trapidil ....................................................................................... 2610Trapidilum ................................................................................ 2610Tretinoin .................................................................................... 2611Tretinoinum.............................................................................. 2611Triacetin ..................................................................................... 2612Triacetinum .............................................................................. 2612Triamcinolone........................................................................... 2613Triamcinolone acetonide........................................................ 2614Triamcinolone hexacetonide ................................................. 2616Triamcinoloni acetonidum................................................... 2614Triamcinoloni hexacetonidum ............................................ 2616Triamcinolonum ..................................................................... 2613Triamterene ............................................................................... 2617Triamterenum .......................................................................... 2617

Tribenoside................................................................................ 2617Tribenosidum ........................................................................... 2617Tributyl acetylcitrate ............................................................... 2619Tributylis acetylcitras............................................................. 2619Tricalcii phosphas............................................................5.8-5285Trichloroacetic acid .................................................................2620Triethanolamine .......................................................................2632Triethyl citrate ..........................................................................2620Triethylis citras ........................................................................2620Trifluoperazine hydrochloride .............................................. 2621Trifluoperazini hydrochloridum......................................... 2621Triflusal ......................................................................................2622Triflusalum ...............................................................................2622Triglycerida saturata media .................................................2623Triglycerides, medium-chain..................................................2623Triglycerides, omega-3-acid.............................................5.4-3995Triglycerol diisostearate ..................................................5.8-5384Triglyceroli diisostearas .................................................5.8-5384Trigonellae foenugraeci semen ...........................................1588Trihexyphenidyl hydrochloride.............................................2625Trihexyphenidyli hydrochloridum .....................................2625Trimetazidine dihydrochloride..............................................2626Trimetazidini dihydrochloridum ........................................2626Trimethadione ..........................................................................2627Trimethadionum .....................................................................2627Trimethoprim.....................................................................5.7-5126Trimethoprimum..............................................................5.7-5126Trimipramine maleate .............................................................2630Trimipramini maleas .............................................................2630Tri-n-butylis phosphas............................................................ 2631Tri-n-butyl phosphate .............................................................. 2631Tritiated (3H) water injection................................................... 867Tritici aestivi oleum raffinatum ..........................................2699Tritici aestivi oleum virginale..............................................2699Tritici amylum .........................................................................2698Trolamine...................................................................................2632Trolaminum..............................................................................2632Trometamol ...............................................................................2633Trometamolum ........................................................................2633Tropicamide...............................................................................2634Tropicamidum .........................................................................2634Tropisetron hydrochloride ..............................................5.6-4700Tropisetroni hydrochloridum .......................................5.6-4700Trospii chloridum ............................................................5.2-3281Trospium chloride.............................................................5.2-3281Troxerutin...........................................................................5.3-3634Troxerutinum ....................................................................5.3-3634Trypsin ................................................................................5.6-4701Trypsinum..........................................................................5.6-4701Tryptophan................................................................................2636Tryptophanum .........................................................................2636TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ........................ 463

TSE, animal, products with risk of transmitting agentsof.................................................................................................. 577

Tuberculin for human use, old..............................................2638Tuberculini aviarii derivatum proteinosumpurificatum......................................................................5.7-5129

Tuberculini bovini derivatum proteinosumpurificatum......................................................................5.7-5130

Tuberculini derivatum proteinosum purificatum ad usumhumanum ...............................................................................2642

Tuberculin purified protein derivative, avian .............5.7-5129Tuberculin purified protein derivative, bovine...........5.7-5130Tuberculin purified protein derivative for human use ....2642Tuberculinum pristinum ad usum humanum ................2638Tubes for comparative tests (2.1.5.) ..........................................19Tubing and closures, silicone elastomer for (3.1.9.)........... 288



Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 285

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 272

Tubocurarine chloride ............................................................2644Tubocurarini chloridum........................................................2644Turmeric, javanese...................................................................2645Turpentine oil, Pinus pinaster type ..............................5.6-4703Tylosin for veterinary use ...............................................5.4-4035Tylosini phosphatis solutio ad usum veterinarium .........5.4-4037

Tylosini tartras ad usum veterinarium ......................5.4-4039Tylosin phosphate bulk solution for veterinary use ..5.4-4037Tylosin tartrate for veterinary use ................................5.4-4039Tylosinum ad usum veterinarium ...............................5.4-4035Typhoid polysaccharide vaccine ............................................. 705Typhoid vaccine.......................................................................... 707Typhoid vaccine, freeze-dried.................................................. 707Typhoid vaccine (live, oral, strain Ty 21a)............................ 708Tyrosine...................................................................................... 2651Tyrosinum................................................................................. 2651Tyrothricin..........................................................................5.1-3028Tyrothricinum...................................................................5.1-3028

UUbidecarenone..........................................................................2657Ubidecarenonum .....................................................................2657Udder-washes .............................................................................. 631Ultraviolet and visible absorption spectrophotometry(2.2.25.) .............................................................................5.6-4383

Ultraviolet ray lamps for analytical purposes (2.1.3.)............17Uncoated tablets................................................................5.8-5239Undecylenic acid ......................................................................2658Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 234

Uniformity of dosage units (2.9.40.) .............................5.3-3370Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 263

Uniformity of mass of single-dose preparations (2.9.5.) .... 233Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ......................................................................................5.6-4373

Unsaponifiable matter (2.5.7.) ................................................. 129Urea.............................................................................................2658Ureum.........................................................................................2658Urofollitropin ............................................................................2659Urofollitropinum .....................................................................2659Urokinase................................................................................... 2661Urokinasum .............................................................................. 2661Uronic acids in polysaccharide vaccines (2.5.22.)............... 133Ursodeoxycholic acid ......................................................5.7-5133Urtica dioica ad praeparationes homoeopathicas ..5.3-3429Urticae folium ...................................................................5.6-4644Uvae ursi folium ...................................................................... 1054

VVaccina ad usum humanum .........................................5.8-5231Vaccina ad usum veterinarium ....................................5.3-3387Vaccines, adsorbed, aluminium in (2.5.13.)...........................131Vaccines, adsorbed, calcium in (2.5.14.).................................131Vaccines and immunosera, phenol in (2.5.15.) .....................131Vaccines and immunosera, veterinary, evaluation of efficacy(5.2.7.)................................................................................5.1-2829

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ...............................................................................5.1-2827

Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ..........................................5.1-2830

Vaccines for human use...................................................5.8-5231Vaccines for human use, cell substrates for the production of(5.2.3.) ........................................................................................ 455

Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 169

Vaccines for veterinary use.............................................5.3-3387Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 132Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 133Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 132Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 132Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 132Vaccines, polysaccharide, protein in (2.5.16.) .......................131Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 137Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 133Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 133Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ...........................................................5.1-2825

Vaccines, terminology (5.2.1.) ................................................. 453Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 458

Vaccines, veterinary, substances of animal origin for theproduction of (5.2.5.) .............................................................. 460

Vaccines, viral live, test for neurovirulence (2.6.18.).......... 172Vaccinum actinobacillosis inactivatum ad suem ............. 784Vaccinum adenovirosidis caninae vivum........................... 738Vaccinum adenovirosis caninae inactivatum ................... 738Vaccinum anaemiae infectivae pulli vivum....................... 769Vaccinum anthracis adsorbatum ab colato culturarum adusum humanum .............................................................5.6-4479

Vaccinum anthracis vivum ad usum veterinarium.......... 715Vaccinum aphtharum epizooticarum inactivatum adruminantes ......................................................................5.1-2860

Vaccinum bronchitidis infectivae aviariaeinactivatum .....................................................................5.4-3881

Vaccinum bronchitidis infectivae aviariae vivum ............ 720Vaccinum brucellosis (Brucella melitensis stirpe Rev. 1)vivum cryodesiccatum ad usum veterinarium ......5.1-2859

Vaccinum bursitidis infectivae aviariae inactivatum ...... 722Vaccinum bursitidis infectivae aviariae vivum ................. 723Vaccinum calicivirosis felinae inactivatum ....................... 757Vaccinum calicivirosis felinae vivum cryodesiccatum ... 758Vaccinum chlamydiosis felinae inactivatum ............5.6-4489Vaccinum cholerae ................................................................... 637Vaccinum cholerae aviariae inactivatum ..................5.1-2861Vaccinum cholerae cryodesiccatum..................................... 638Vaccinum clostridii botulini ad usum veterinarium ....... 745Vaccinum clostridii chauvoei ad usum veterinarium ..... 745Vaccinum clostridii novyi B ad usum veterinarium ....... 746Vaccinum clostridii perfringentisad usum veterinarium ........................................................... 747

Vaccinum clostridii septici ad usum veterinarium .......... 749Vaccinum colibacillosis fetus a partu recentis inactivatumad ruminantes ......................................................................... 778

Vaccinum colibacillosis fetus a partu recentis inactivatumad suem ..................................................................................... 776

Vaccinum diarrhoeae viralis bovinae inactivatum .......... 734Vaccinum diphtheriae adsorbatum ...................................... 660Vaccinum diphtheriae, antigeniis minutum,adsorbatum......................................................................5.6-4485

Vaccinum diphtheriae et tetani adsorbatum ..................... 639Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum,adsorbatum......................................................................5.6-4480

Vaccinum diphtheriae, tetani et hepatitidis B (ADNr)adsorbatum............................................................................... 641

Vaccinum diphtheriae, tetani et pertussis adsorbatum .. 643Vaccinum diphtheriae, tetani et pertussis sine cellulis exelementis praeparatum adsorbatum.........................5.4-3851



Vaccinum diphtheriae, tetani et poliomyelitidisinactivatum, antigeni-o(-is) minutum, adsorbatum.......5.6-4481

Vaccinum diphtheriae, tetani, pertussis et poliomyelitidisinactivatum adsorbatum ..............................................5.4-3864

Vaccinum diphtheriae, tetani, pertussis, poliomyelitidisinactivatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3866

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et haemophili stirpe b coniugatumadsorbatum......................................................................5.4-3852

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum et hepatitidis B (ADNr)adsorbatum......................................................................5.4-3854

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatumadsorbatum......................................................................5.4-3856

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum et poliomyelitidis inactivatum,antigeni-o(-is) minutum, adsorbatum.......................5.6-4483

Vaccinum diphtheriae, tetani, pertussis sine cellulisex elementis praeparatum, hepatitidis B (ADNr),poliomyelitidis inactivatum et haemophili stirpe bconiugatum adsorbatum ..............................................5.4-3858

Vaccinum diphtheriae, tetani, pertussis sine cellulis exelementis praeparatum, poliomyelitidis inactivatum ethaemophili stirpe b coniugatum adsorbatum ........5.4-3861

Vaccinum encephalitidis ixodibus advectaeinactivatum .....................................................................5.3-3414

Vaccinum encephalomyelitidis infectivae aviariaevivum.......................................................................................... 725

Vaccinum erysipelatis suillae inactivatum ........................ 793Vaccinum febris flavae vivum.......................................5.1-2852Vaccinum febris typhoidi ........................................................ 707Vaccinum febris typhoidi cryodesiccatum ......................... 707Vaccinum febris typhoidis polysaccharidicum ................. 705Vaccinum febris typhoidis vivum perorale (stirpeTy 21a) ....................................................................................... 708

Vaccinum furunculosidis ad salmonidas inactivatum cumadiuvatione oleosa ad iniectionem .................................... 767

Vaccinum haemophili stirpe b coniugatum....................... 662Vaccinum hepatitidis A inactivatum adsorbatum ............ 665Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr)adsorbatum............................................................................... 664

Vaccinum hepatitidis A inactivatum virosomale .............. 667Vaccinum hepatitidis B (ADNr)............................................. 670Vaccinum hepatitidis viralis anatis stirpe I vivum .......... 751Vaccinum herpesviris equini inactivatum ......................... 754Vaccinum inactivatum diarrhoeae vituli coronaviroillatae ......................................................................................... 736

Vaccinum inactivatum diarrhoeae vituli rotaviroillatae ......................................................................................... 737

Vaccinum influenzae equi inactivatum .............................. 755Vaccinum influenzae inactivatum ad suem ...................... 785Vaccinum influenzae inactivatum ex cellulis corticisqueantigeniis praeparatum................................................5.5-4173

Vaccinum influenzae inactivatum ex cellulis virisqueintegris praeparatum ....................................................5.5-4175

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum....................................................................5.3-3402

Vaccinum influenzae inactivatum ex corticis antigeniispraeparatum virosomale ..............................................5.3-3404

Vaccinum influenzae inactivatum ex viris integrispraeparatum....................................................................5.3-3406

Vaccinum influenzae inactivatum ex virorum fragmentispraeparatum....................................................................5.3-3401

Vaccinum laryngotracheitidis infectivae aviariaevivum.......................................................................................... 727

Vaccinum leptospirosis bovinae inactivatum .................... 730

Vaccinum leptospirosis caninae inactivatum ................... 740Vaccinum leucosis felinae inactivatum................................761Vaccinum mannheimiae inactivatum ad bovidas ............ 771Vaccinum mannheimiae inactivatum ad ovem ................ 772Vaccinum meningococcale classis C coniugatum ........... 680Vaccinum meningococcale polysaccharidicum................ 682Vaccinum morbi Aujeszkyi ad suem inactivatum ............ 715Vaccinum morbi Aujeszkyi ad suem vivum cryodesiccatumad usum parenterale ...............................................................717

Vaccinum morbi Carrei vivum cryodesiccatum ad canem..................................................................................................... 740

Vaccinum morbi Carrei vivum cryodesiccatum admustelidas ................................................................................. 751

Vaccinum morbillorum, parotitidis et rubellae vivum .... 678Vaccinum morbillorum vivum............................................... 679Vaccinum morbi Marek vivum .....................................5.6-4489Vaccinum morbi partus diminutionis MCMLXXVIinactivatum ad pullum .......................................................... 753

Vaccinum mycoplasmatis galliseptici inactivatum..........5.6-4491

Vaccinum myxomatosidis vivum ad cuniculum ............... 775Vaccinum panleucopeniae felinae infectivaeinactivatum .............................................................................. 759

Vaccinum panleucopeniae felinae infectivae vivum ....... 760Vaccinum parainfluenzae viri bovini vivumcryodesiccatum ....................................................................... 732

Vaccinum parainfluenzae viri canini vivum..................... 742Vaccinum paramyxoviris 3 aviarii inactivatum ............... 728Vaccinum parotitidis vivum ................................................... 684Vaccinum parvovirosis caninae inactivatum .................... 743Vaccinum parvovirosis caninae vivum ............................... 744Vaccinum parvovirosis inactivatum ad suem ................... 787Vaccinum pasteurellae inactivatum ad ovem.................... 783Vaccinum pertussis................................................................... 685Vaccinum pertussis adsorbatum ........................................... 690Vaccinum pertussis sine cellulis copurificatumadsorbatum............................................................................... 688

Vaccinum pertussis sine cellulis ex elementis praeparatumadsorbatum......................................................................5.3-3407

Vaccinum pestis anatis vivum ......................................5.3-3419Vaccinum pestis classicae suillae vivumcryodesiccatum ....................................................................... 793

Vaccinum pneumococcale polysaccharidicum ................. 691Vaccinum pneumococcale polysaccharidicum coniugatumadsorbatum......................................................................5.5-4177

Vaccinum poliomyelitidis inactivatum ......................5.4-3868Vaccinum poliomyelitidis perorale .............................5.3-3410Vaccinum pseudopestis aviariae inactivatum ..........5.6-4492Vaccinum pseudopestis aviariae vivum .............................. 781Vaccinum rabiei ex cellulis ad usum humanum .....5.8-5245Vaccinum rabiei inactivatum ad usum veterinarium ..... 790Vaccinum rabiei perorale vivum ad vulpem ...................... 792Vaccinum rhinitidis atrophicantis ingravescentis suillaeinactivatum .............................................................................. 788

Vaccinum rhinotracheitidis infectivae bovinae vivumcryodesiccatum ....................................................................... 768

Vaccinum rhinotracheitidis viralis felinaeinactivatum .....................................................................5.7-4951

Vaccinum rhinotracheitidis viralis felinae vivum ...5.7-4952Vaccinum rubellae vivum ....................................................... 701Vaccinum Salmonellae Enteritidis inactivatum adpullum...............................................................................5.8-5249

Vaccinum Salmonellae Typhimurium inactivatum adpullum...............................................................................5.8-5250

Vaccinum tenosynovitidis viralis aviariae vivum ............ 729Vaccinum tetani adsorbatum ................................................. 702Vaccinum tetani ad usum veterinarium ....................5.6-4494Vaccinum tuberculosis (BCG) cryodesiccatum ................. 636Vaccinum varicellae vivum .................................................... 709



Vaccinum variolae gallinaceae vivum ............................... 766Vaccinum variolae vivum ..............................................5.4-3873Vaccinum vibriosidis ad salmonidas inactivatum ........... 797Vaccinum vibriosidis aquae frigidae inactivatum adsalmonidas................................................................................ 796

Vaccinum viri syncytialis meatus spiritus bovini vivumcryodesiccatum ....................................................................... 733

Vaginal capsules ................................................................5.5-4169Vaginal foams.....................................................................5.5-4169Vaginalia ............................................................................5.5-4168Vaginal preparations ........................................................5.5-4168Vaginal preparations, semi-solid ....................................5.5-4169Vaginal solutions and suspensions, tablets for...........5.5-4169Vaginal solutions, emulsions and suspensions...........5.5-4169Vaginal tablets ...................................................................5.5-4169Vaginal tampons, medicated...........................................5.5-4170Valerianae extractum hydroalcoholicum siccum ....5.7-5137Valerianae radix ...............................................................5.7-5138Valerianae tinctura ..........................................................5.7-5139Valerian dry hydroalcoholic extract..............................5.7-5137Valerian root.......................................................................5.7-5138Valerian tincture................................................................5.7-5139Validation of nucleic acid amplification techniques for thedetection of hepatitis C virus (HCV) RNA in plasma pools :Guidelines.........................................................................5.5-4113

Valine ..........................................................................................2668Valinum .....................................................................................2668Valnemulin hydrochloride for veterinary use ............5.6-4707Valnemulini hydrochloridum ad usum veterinarium .....5.6-4707

Valproic acid..............................................................................2669Vancomycin hydrochloride ....................................................2670Vancomycini hydrochloridum .............................................2670Vanillin .......................................................................................2672Vanillinum ................................................................................2672Varicella immunoglobulin for intravenous administration,human ...................................................................................... 1753

Varicella immunoglobulin, human....................................... 1752Varicella vaccine (live)............................................................... 709Vaselinum album..................................................................... 2187Vaselinum flavum ................................................................... 2188Vectors for human use, adenovirus ..............................5.6-4462Vectors for human use, plasmid ....................................5.6-4466Vectors for human use, plasmid, bacterial cells used for themanufacture of ................................................................5.6-4468

Vectors for human use, poxvirus ...................................5.6-4464Vecuronii bromidum .......................................................5.7-5140Vecuronium bromide........................................................5.7-5140Vegetable drugs, determination of essential oils in vegetabledrugs (2.8.12.) ...........................................................................217

Vegetable fatty oils............................................................5.8-5233Venlafaxine hydrochloride ..............................................5.5-4319Venlafaxinum hydrochloridum ....................................5.5-4319Verapamil hydrochloride ........................................................2673Verapamili hydrochloridum .................................................2673Verbasci flos..............................................................................2065Verbenae citriodoratae folium ......................................5.8-5329Verbenae herba .................................................................5.6-4708Verbena herb......................................................................5.6-4708Veterinary liquid preparations for cutaneous application.. 630Via praeparandi stirpes homoeopathicas etpotentificandi..................................................................5.8-5260

Vibriosis (cold-water) vaccine (inactivated) for salmonids.. 796Vibriosis vaccine (inactivated) for salmonids....................... 797VICH (5.8.) ................................................................................... 551Vinblastine sulphate ................................................................2675Vinblastini sulfas .....................................................................2675Vincristine sulphate.................................................................2675Vincristini sulfas .....................................................................2675

Vindesine sulphate ..................................................................2677Vindesini sulfas .......................................................................2677Vinorelbine tartrate ..........................................................5.1-3033Vinorelbini tartras............................................................5.1-3033Violae herba cum flore ..........................................................2700Viper venom antiserum, European ........................................ 806Viral rhinotracheitis vaccine (inactivated), feline.......5.7-4951Viral rhinotracheitis vaccine (live), feline ....................5.7-4952Viral safety (5.1.7.) ............................................................5.8-5213Viscometer method, capillary (2.2.9.) ...................................... 29Viscometer method, falling ball (2.2.49.) ................................ 80Viscose wadding, absorbent .................................................. 2681Viscosity (2.2.8.) ........................................................................... 29Viscosity - rotating viscometer method (2.2.10.) ........5.3-3337Visible and ultraviolet absorption spectrophotometry(2.2.25.) .............................................................................5.6-4383

Visible particles, particulate contamination (2.9.20.) ........ 255Vitamin A ............................................................................5.6-4710Vitamin A concentrate (oily form), synthetic ..............5.6-4711Vitamin A concentrate (powder form), synthetic .......5.6-4713Vitamin A concentrate (solubilisate/emulsion),synthetic ...........................................................................5.6-4714

Vitaminum A .....................................................................5.6-4710Vitaminum A densatum oleosum ................................5.6-4711Vitaminum A in aqua dispergibile ..............................5.6-4714Vitaminum A pulvis.........................................................5.6-4713Volumetric analysis (4.2.) ................................................5.7-4937Volumetric solutions (4.2.2.)...........................................5.7-4938Volumetric solutions, primary standards for (4.2.1.) ..5.7-4937von Willebrand factor, human .......................................5.6-4606Von Willebrand factor, human, assay of (2.7.21.).......5.5-4120

WWarfarin sodium....................................................................... 2691Warfarin sodium clathrate ..................................................... 2691Warfarinum natricum............................................................ 2691Warfarinum natricum clathratum ...................................... 2691Washes, nasal .....................................................................5.6-4474Water (15O) injection.................................................................. 868Water, determination by distillation (2.2.13.) ........................ 32Water for diluting concentrated haemodialysissolutions .................................................................................. 1699

Water for injections .................................................................2692Water for pharmaceutical use, total organic carbon in(2.2.44.) ........................................................................................ 68

Water, highly purified .............................................................2695Water in essential oils (2.8.5.) ..................................................216Water in gases (2.5.28.) ............................................................ 136Water: micro determination (2.5.32.) .................................... 137Water, purified..........................................................................2697Water : semi-micro determination (2.5.12.) .................5.7-4785Wheat-germ oil, refined ..........................................................2699Wheat-germ oil, virgin.............................................................2699Wheat starch .............................................................................2698White beeswax ...................................................................5.4-3901White horehound..............................................................5.1-3039White soft paraffin................................................................... 2187Wild pansy (flowering aerial parts)......................................2700Wild thyme ................................................................................ 2701Willow bark ...............................................................................2702Wool alcohols............................................................................2703Wool fat ...............................................................................5.8-5387Wool fat, hydrogenated...........................................................2708Wool fat, hydrous.....................................................................2709Wormwood .........................................................................5.8-5391

XXanthan gum ............................................................................ 2715



Xanthani gummi ..................................................................... 2715Xenon (133Xe) injection.............................................................. 869Xenoni (133Xe) solutio iniectabilis ......................................... 869X-ray fluorescence spectrometry (2.2.37.)............................... 56X-ray powder diffraction (XRPD), characterisationof crystalline and partially crystalline solids by(2.9.33.) .............................................................................5.6-4432

Xylazine hydrochloride for veterinary use ......................... 2716Xylazini hydrochloridum ad usum veterinarium .......... 2716Xylitol...................................................................................5.3-3647Xylitolum ............................................................................5.3-3647Xylometazoline hydrochloride .......................................5.6-4723Xylometazolini hydrochloridum ..................................5.6-4723Xylose..........................................................................................2720Xylosum .....................................................................................2720

YYarrow .................................................................................5.7-5145Yellow beeswax ..................................................................5.4-3902Yellow fever vaccine (live) ...............................................5.1-2852Yellow soft paraffin.................................................................. 2188Yohimbine hydrochloride ................................................5.7-5146Yohimbini hydrochloridum ...........................................5.7-5146

ZZidovudine..........................................................................5.1-3043

Zidovudinum .....................................................................5.1-3043Zinc acetate dihydrate.............................................................2728Zinc acexamate .........................................................................2729Zinc chloride .............................................................................2730Zinci acetas dihydricus .........................................................2728Zinci acexamas ........................................................................2729Zinci chloridum .......................................................................2730Zinci oxidum .....................................................................5.5-4323Zinci stearas .............................................................................2732Zinci sulfas heptahydricus....................................................2732Zinci sulfas hexahydricus .....................................................2733Zinci sulfas monohydricus ............................................5.4-4053Zinci undecylenas...................................................................2733Zinc oxide............................................................................5.5-4323Zinc stearate..............................................................................2732Zinc sulphate heptahydrate ...................................................2732Zinc sulphate hexahydrate.....................................................2733Zinc sulphate monohydrate ............................................5.4-4053Zinc undecylenate ....................................................................2733Zingiberis rhizoma ................................................................. 1656Zolpidemi tartras.....................................................................2734Zolpidem tartrate .....................................................................2734Zopiclone ...................................................................................2735Zopiclonum...............................................................................2735Zuclopenthixol decanoate ...............................................5.6-4727Zuclopenthixoli decanoas ..............................................5.6-4727


european pharmacopoeia 5.8 index - 医药招商 药 … · · 2007-02-102.9.17. test for...

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european pharmacopoeia 5.8 index - 医药招商药 … · · 2007-02-102.9.17. test for...