cumulative list - usp-nf | usp-nf · xls file · web view ·...

2015-2020 Cumulative List of USP–NF Revisions(includes all items approved/posted from July 1, 2015 to July 29, 2016)

Monograph Title Monograph Section EC Scientific Liaison Revision Vehicle Category Result Ballot Posted Published Official USP-NF Explanation of Deferral, Cancellation, or Errata correction Entered

Banaba Leaf Dry Extract IDENTIFICATION BDSHM Maria Juan Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Curcuminoids BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Curcuminoids Capsules BDSHM Natalia Davydova Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Curcuminoids Tablets BDSHM Natalia Davydova Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Digoxin BDSHM Nam-Cheol Kim Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

DIGOXIN INJECTION IDENTIFICATION/B. BDSHM Nam-Cheol Kim Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

DIGOXIN ORAL SOLUTION IDENTIFICATION/B. BDSHM Nam-Cheol Kim Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

DIGOXIN TABLETS IDENTIFICATION/A. BDSHM Nam-Cheol Kim Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

BDSHM Natalia Davydova Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

EVENING PRIMROSE OIL CAPSULES BDSHM Natalia Davydova Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Guggul Tablets BDSHM Natalia Davydova Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Holy Basil Leaf BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Milk Thistle BDSHM Anton Bzhelyansky Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Milk Thistle Capsules BDSHM Natalia Davydova Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Milk Thistle Tablets BDSHM Natalia Davydova Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Powdered Ashwagandha Root Extract BDSHM Anton Bzhelyansky Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

USP 41-NF 36 (Print) USP 40-NF 35 1S (Online)

Delete Identification A.ANDLine 1 of Identification B: ChangeB.to:A.ANDLine 1 of Identification C: ChangeC.to:B.

COMPOSITION/Content of Curcuminoids/Chromatographic system

Line 1 of Column: Change4.6-mm × 20-cm;to:4.6-mm × 25-cm;

STRENGTH/Content of Curcuminoids/Chromatographic system


STRENGTH/Content of Curcuminoids/Chromatographic system


IMPURITIES/Related Glycosides/System suitabilityUSP 40-NF 35 (Online & Print)

Line 2: ChangeSample: System suitability solutionto:Samples: System suitability solution and Standard solutionANDLine 2 of Suitability requirements: ChangeResolution: NLT 1.5 between the digoxin and lanatoside C peaks Relative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injectionsto:Resolution: NLT 1.5 between the digoxin and lanatoside C peaks,System suitability solutionRelative standard deviation: NMT 2.0%, determined from the digoxin peak in replicated injections, Standard solution


Line 1 of Procedure: ChangeProceed as directed for Procedure in the test for Related glycosides under Digoxin, except to omit the use of the Gitoxin standard solution. to: Apply 10 µL of the Test solution and 10 µL of the Standard solution on a line parallel to and about 2.5 cm from the bottom edge of a reversed-phase thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture to which is permanently bonded octadecylsilane (C18). Allow the spots to dry, and place the plates in a developing chamber containing a mixture of methanol and water (7:3). Develop the chromatogram until the solvent front has moved about 15 cm above the line of application. Remove the plate, and allow the solvent to evaporate. Spray the plate with Chloramine T–trichloroacetic acid reagent, freshly mixed, and heat in an oven at 110° for 10 minutes.





EVENING PRIMROSE OIL CAPSULESSTRENGTH/Analysis USP41-NF36

In the first variable definition list: ChangemS = weight of USP Methyl Ester RS in the Standard solution (mg)to:mS = weight of the relevant USP Methyl Ester RS in the Standard solution (mg)

STRENGTH/Analysis

In the first variable definition list: Change mS = weight of USP Methyl Ester RS in the Standard solution (mg) to:mS = weight of the relevant USP Methyl Ester RS in the Standard solution (mg)

ADDITIONAL REQUIREMENTS

Line 1 of Labeling: Change binominalto:binomial



COMPOSITION/Content of Silymarin


Line 3 of Sample stock solution: ChangeTransfer the thimble to a continuous-extraction apparatus fitted with a250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,to:Transfer the thimble to a continuous-extraction apparatus fitted with a250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

STRENGTH/Content ofSilymarin USP41-NF36

Row 2 of Column 2 of Table 1: Change0to:85ANDRow 2 of Column 3 of Table 1: Change0 to:15

STRENGTH/Content ofSilymarin USP41-NF36

Row 2 of Column 2 of Table 1: Change0 to:85ANDRow 2 of Column 3 of Table 1: Change0 to:15

COMPOSITION/Content of Withanolides

USP41-NF36 1S (Online) USP42-NF37 (Print)

AddSolution B: Acetonitrile, filtered and degassed

POWDERED CHASTE TREE EXTRACT CONTAMINANTS BDSHM Anton Bzhelyansky Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Powdered Holy Basil Leaf BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Powdered Milk Thistle BDSHM Anton Bzhelyansky Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Powdered Milk Thistle Extract BDSHM Anton Bzhelyansky Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Powdered Turmeric BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Powdered Turmeric Extract BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Turmeric BDSHM Anton Bzhelyansky Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Corticotropin for Injection BIO1 Edith Chang Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Corticotropin Injection BIO1 Edith Chang Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

DESMOPRESSIN ACETATE IDENTIFICATION/A. Mass Spectral Analysis BIO1 Elena Curti Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Octreotide Acetate BIO1 Trish Li Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Repository Corticotropin Injection BIO1 Edith Chang Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Alteplase BIO2 Edith Chang Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Alteplase for Injection BIO2 Edith Chang Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

BIO3 Rebecca Potts Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS BIO3 Rebeccca Potts Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017


BIO3 Rebeccca Potts Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Enoxaparin Sodium Injection BIO3 Chisty Basha Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017


SCAFFOLD BOVINE DERMIS SPECIFIC TESTS BIO3 Rebeccca Potts Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Bacitracin Zinc IMPURITIES CHM1 Morgan Puderbaugh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Cefdinir for Oral Suspension CHM1 Morgan Puderbaugh Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

CIPROFLOXACIN ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM1 Shankari Shivaprasad Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016


ChangeMicrobial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 1000 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. to:Microbial Enumeration Tests <2021>: The total bacterial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 103 cfu/g.Absence of Specified Microorganisms <2022>: Meets the requirements of the tests for absence of Salmonella species and Escherichia coli



COMPOSITION/Content of Silymarin


Line 3 of Sample stock solution: ChangeTransfer the thimble to a continuous-extraction apparatus fitted with a250-mL round-bottom flask containing 150 mL of hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the hexane. Dry the extraction thimble to remove residual hexane,to:Transfer the thimble to a continuous-extraction apparatus fitted with a250-mL round-bottom flask containing 150 mL of solvent hexane, and heat the flask on a heating mantle for 4 h. After the extraction, detach the round-bottom flask from the extraction apparatus, and discard the solvent hexane. Dry the extraction thimble to remove residual solvent hexane,

COMPOSITION/Content ofSilymarin USP41-NF36

Row 2 of Column 2 of Table 1: Change0 to:85ANDRow 2 of Column 3of Table 1: Change0 to:15






Line 1 of Column: Change4.6-mm × 20-cm;to:

ASSAY/Procedure


Line 7 of Replication: Change(see <111>, Confidence Intervals for Individual Assays). to:(see <111>, The Confidence Interval and Limits of Potency).

ASSAY/Procedure




Line 6 of Instrumental conditions: DeleteFlow rate: 0.7 mL/minInjection volume: 10 µL/min

IDENTIFICATION/B. Amino AcidAnalysis

Line 1 of Standard amino acid mixture: Change2500 nmol/mL of to:2500 nmol/mL each of

ASSAY/Procedure



ASSAY/Biological Potency


Line 1 of Human thrombin solution: Change33 Units in terms of the U.S. Standard Thrombin/mL in Bufferto:33 U.S. Units in terms of the U.S. Standard Thrombin/mL in BufferANDLine 5 of Analysis: ChangeStandard solution and Sample solution, to:Standard solution or Sample solution,

ASSAY/BiologicalPotency


Line 1 of Human thrombin solution: Change33 Units in terms of the U.S. Standard Thrombin/mL in Bufferto:33 U.S. Units in terms of the U.S. Standard Thrombin/mL in BufferANDLine 5 of Analysis: ChangeStandard solution and Sample solution, to:Standard solution or Sample solution,

<127> FLOW CYTOMETRIC ENUMERATION OF CD34+ CELLS SAMPLE PREPARATIO N/Table 1. Dot Plot Descriptions and Gating Instructions USP41-NF36Column 4 for Step 6: Add? For counting bead enumeration, proceed to either Step 7 or Step 8 according to the recommendations of the bead manufacturer.

SAMPLE PREPARATION/Table 1. Dot Plot Descriptions and Gating InstructionsColumn 4 for Step 6: Add For counting bead enumeration, proceed to either Step 7 or Step 8 according to the recommendations of the bead manufacturer.

CONSTRUCT HUMAN FIBROBLASTS IN BILAYER SYNTHETIC SCAFFOLD SPECIFIC TESTS/Meta bolic Activity Assessment USP41-NF36

Line 2 of L-Glutamine solution: Change29.2 g to:2.92 g

CONSTRUCT HUMAN FIBROBLASTS IN BILAYER SYNTHETIC SCAFFOLD SPECIFIC TESTS/Metabolic Activity Assessment Line 2 of L-Glutamine solution: Change 29.2 g to: 2.92 g

SPECIFIC TESTS/Anti-Factor IIa Activity


DeleteStandard solutions: Dilute USP Enoxaparin Sodium Solution for Bioassays RS with pH 7.4 buffer to obtain four dilutions having concentrations in the range between 0.015 and 0.075 IU of Anti-Factor IIa activity/mL.

SCAFFOLD BOVINE DERMIS SPECIFIC TESTS USP41-NF36

Line 5 of Carbohydrate Content/Acceptance criteria: ChangeMoisture Contentto:Loss on DryingANDLine 3 of Suture Retention Force/Analysis: Change40 to:4-0

Line 5 of Carbohydrate Content/Acceptance criteria: ChangeMoisture Contentto:Loss on DryingANDLine 3 of Suture Retention Force/Analysis: Change40to:4-0

USP 40-NF 35 (Online & Print) Delete the Residue on Ignition <281> test.

PERFORMANCE TESTS/Dissolution<711>


Line 5 of Analysis: ChangeResult = (AU/AS) × CS × d × V × D × (1/L) × 100 to:Result = (AU/AS) × CS × (d/WU) × V × D × (1/L) × 100ANDAdd to the variable definition listWU = weight of reconstituted Cefdinir for Oral Suspension taken (mg)


Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.C15H16FN3O3 305.30 to: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.C15H16FN3O3 · HCl 341.77

CIPROFLOXACIN HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM1 Shankari Shivaprasad Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Clotrimazole And Betamethasone Dipropionate Cream CHM1 Shankari Shivaprasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Clotrimazole And Betamethasone Dipropionate Cream CHM1 Shankari Shivaprasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Efavirenz CHM1 Shankari Shivaprasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Efavirenz CHM1 Shankari Shivaprasad Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Entecavir CHM1 Shankari Shivaprasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Imiquimod Cream CHM1 Shankari Shivaprasad Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Imiquimod Cream CHM1 Shankari Shivaprasad Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Lopinavir And Ritonavir Oral Solution CHM1 Shankari Shivaprasad Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Mebendazole CHM1 Shankari Shivaprasad Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Minocycline Hydrochloride Extended- Release Tablets CHM1 Praveen Pabba Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS IMPURITIES/Organic Impurities/Table 6 CHM1 Praveen Pabba Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Penicillin G Procaine CHM1 Ramanujam Prasad Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Ribavirin Tablets CHM1 Shankari Shivaprasad Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Tacrolimus Capsules CHM1 Mary Koleck Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Tetracycline Hydrochloride CHM1 Praveen Pabba Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Tetracycline Hydrochloride Capsules CHM1 Morgan Puderbaugh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016


Line 2 of USP Ciprofloxacin Ethylenediamine Analog RS: Change7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.C15H16FN3O3 305.30 to: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[(2-aminoethyl)amino]-3-quinolinecarboxylic acid hydrochloride.C15H16FN3O3 · HCl 341.77

IMPURITIES/Organic Impurities: Limit of Clotrimazole Related Compound A

In the variable definition list in Analysis: ChangeCS = concentration of USP Clotrimazole Related Compound A RS in the Clotrimazole related compound A stock solution (mg/mL)to:CS = concentration of USP Clotrimazole Related Compound A RS in the Standard solution (mg/mL)

ASSAY/Procedure

In the first variable definition list in Analysis: ChangeCS = concentration of USP Clotrimazole RS in the Clotrimazole stock solution (mg/mL)to:CS = concentration of USP Clotrimazole RS in the Standard solution (mg/mL) ANDIn the second variable definition list in Analysis: ChangeCS = concentration of USP Betamethasone Dipropionate RS in the Betamethasone dipropionate stock solution (mg/mL)to:CS = concentration of USP Betamethasone Dipropionate RS in the Standard solution (mg/mL)

IMPURITIES/Organic Impurities

Row 4 of Column 1 ofProcedure 1/Impurity Table1:ChangeEfavirenz pent-3-ene-1-yne(cis)cto:Efavirenz pent-3-ene-1-yne(trans)cANDRow 5 of Column 1 ofProcedure 1/Impurity Table1:ChangeEfavirenz pent-3-ene-1-yne(trans)dto:Efavirenz pent-3-ene-1-yne(cis)dANDRow 3 of Column 1 ofProcedure 2/Impurity Table2: ChangeEfavirenz pent-3-ene-1-yne(cis)ato:Efavirenz pent-3-ene-1-yne(trans)aANDRow 4 of Column 1 ofProcedure 2/Impurity Table2:ChangeEfavirenz pent-3-ene-1-yne(trans)bto:Efavirenz pent-3-ene-1-yne(cis)b

SPECIFIC TESTS/Enantiomeric Purity


Line 1 of Mobile phase: ChangeHexane and ethanol (97:3)to:Hexane and absolute alcohol (97:3)

ASSAY/Procedure

Line 5 of Analysis: Change Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 to:Result = (rU/rS) × (CS/CU) ×100ANDLine 14 of Analysis: Delete Mr1=molecular weight of anhydrous entecavir, 277.28Mr2=molecular weight of entecavir, 295.29

SPECIFIC TESTS/pH <791>


Line 1 of Sample: ChangeNominally 50 mg/mL of imiquimod from Cream in water. to:Nominally 2.5 mg/mL of imiquimod from Cream in water.

IMPURITIES/Organic ImpuritiesUSP 40-NF 35 (Online & Print)

Row 2 of Column 3 of Table 2: Change1.5 to:1.15ANDRow 3 of Column 3 of Table 2: Change1.15 to:1.5



Row 17 of Column 3 of Table 2: Change0.2 to:0.2pANDAdd footnotepDisregard any peak less than 0.01%.

IMPURITIES/Organic Impurities/Table 2


Change footnotesdEthyl 5-benzoyl-1-methylbenzimidazol-2- ylcarbamate.eMethyl 5-(4-toluoyl)-1-methylbenzimidazol-2- ylcarbamate.to:dEthyl (5-benzoyl-1H-benzimidazol-2-yl)carbamate.eMethyl 5-(4-toluoyl)-1H-benzimidazol-2-ylcarbamate.

IMPURITIES/OrganicImpurities USP41-NF36

Change Buffer, Mobile phase, Diluent, and Sample solution: Prepare as directed in the Assay.to:Buffer, Mobile phase, and Diluent: Prepare as directed in the Assay.AND AddSample solution: Use the Sample stock solution as directed in the Assay.


Footnote c: Change(4R,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide. to: (4S,4aS,5aR,12aS)-4-Dimethylamino-3,10,12,12a-tetrahydroxy-7-methylamino-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide.

SPECIFIC TESTS/Content of Penicillin G and Procaine/Analysis USP41-NF36

Line 7 of the variable definition list for the first equation: Change CU = concentration of Penicillin G Procaine in the Sample solution (mg)to:CU = concentration of Penicillin G Procaine in the Sample solution (mg/mL)ANDLine 7 of the variable definition list for the second equation: Change CU = concentration of Penicillin G Procaine in the Sample solution (mg)to:CU = concentration of Penicillin G Procaine in the Sample solution (mg/mL)

IMPURITIES/Organic Impurities, Procedure 1


Footnote e of Table 2: Change1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide. to:1-β-D-Ribofuranosyl-1H-1,2,4-triazole-5-carboxamide.

PERFORMANCE TESTS/Dissolution<711>/Test 5

Line 1 of Medium: Change0.5 g/Lto:0.05 g/L


Line 16 of Analysis: Delete Calculate the percentage of any unspecified impurity in the portion of Tetracycline Hydrochloride taken:Result = (rU/rS) × (CS/CU) ×100rU = peak response of any unspecified impurity from the Sample solutionrS = peak response of tetracycline from the Standard solutionCS = concentration of USP Tetracycline Hydrochloride RS in the Standard solution (µg/mL)CU = concentration of Tetracycline Hydrochloride in the Sample solution (µg/mL)

ASSAY/ProcedureUSP 40-NF 35 (Online & Print)

Line 6 of Sample solution: Change dilute with Diluent to volume.to:dilute with Solution A to volume.

Valganciclovir Hydrochloride Assay CHM1 Shankari Shivaprasad Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

CHM2 Hillary Cai Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017ACETYLCYSTEINE SOLUTION CHM2 Hillary Cai Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Candesartan Cilexetil and Hydrochloro Thiazide Tablets CHM2 Sujatha Ramakrishna Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Candesartan Cilexetil Tablets CHM2 Edith Chang Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Clonidine Hydrochloride CHM2 Edith Chang Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Diclofenac Sodium Extended-Release Tablets CHM2 Wei Yang Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Diluted Isosorbide Mononitrate CHM2 Sujatha Ramakrishna Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Dobutamine Injection CHM2 Edith Chang Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Enalapril Maleate Tablets CHM2 Edith Chang Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Ezetimibe CHM2 Edith Chang Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Ezetimibe CHM2 Edith Chang Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Fenoldopam Mesylate CHM2 Edith Chang Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

CHM2 Wei Yang Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CHM2 Wei Yang Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016


CHM2 Edith Chang Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017


Line 4 of Procedure: ChangeCalculate the percentage, on the anhydrous and solvent-free basis, ofC14H22N6O5 · HCl to:Calculate the percentage of valganciclovir hydrochloride (C14H22N6O5 · HCl)ANDLine 8 of Procedure: Change100[(rU / WU)(CF )(100) /(100 - SU)]to:100[(rU/WU)(CF)(100)] ANDLine 12 of Procedure: ChangeCF is the correction factor; and SU is the total percent of solvent and water in the test sample.to:and CF is the correction factor. ANDLine 16 of Procedure: Change(WS / RS)[(100 - SS) /100]to:(WS/RS)/100ANDLine 18 of Procedure: ChangeRS is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation; and SS is the total percent of solvent and water in USP Valganciclovir Hydrochloride RS. to:and RS is the area response (sum of two peaks for valganciclovir diastereomers) obtained from the Standard preparation.

ACETYLCYSTEI NE SOLUTION ASSAY/Proc edure USP41-NF36

Line 3 of Sample solution: ChangeStandard stock solutionto:Sample stock solution

ASSAY/Procedure Line 3 of Sample solution: Change Standard stock solution to: Sample stock solution


Row 3 of Column 1 of Table 6:ChangeCandesartan related compound Ab,cto:Candesartan cilexetil related compound Ab,c

ADDITIONAL REQUIREMENTS/ USP Reference Standards <11>


Line 2 of USP Candesartan Cilexetil Related CompoundD RS: Change1-{[(Cyclohexyloxycarbonyloxy)carbonyl]oxy}ethyl 3-{[2?-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl]methyl}-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate. to:1-{[(Cyclohexyloxy)carbonyl]oxy}ethyl 3-({2?-(2- ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl}methyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate.


Row 6 of Column 1 of Table1: ChangeTotal impuritiesbto:Total impurities


Line 1 of Standard solution: Change0.001 mg/mL of USP Diclofenac Sodium RS in Diluentto:0.001 mg/mL each of USP Diclofenac Sodium RS and USP DiclofenacRelated Compound A RS in Diluent

USP Reference standards<11>


Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change1,4:3,5-Dianhydro-D-glucitol 2-nitrate.to:1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

IDENTIFICATION/A. USP41-NF36

Line 1 of Sample solution: Change10 mg/mL of dobutamine hydrochloride in methanol, clarified by centrifugation to:Use the neatInjection.

PERFORMANCE TESTS/Dissolution <711>/Table 1


Row 3 of Column 3: Change100 to:200

IMPURITIES/Organic Impurities, Procedure 2/Chromatographic system

Line 2 of Column: ChangeL##1 to: L93ANDDelete footnote 1

IMPURITIES/OrganicImpurities, Procedure1/System suitability/Suitability requirements USP41-NF36

Line 2 of Resolution: ChangeStandard solutionto:System suitability solution

USP Reference standards <11>


Line 2 of USP Fenoldopam Related Compound A RS: Change1-Methyl-3-benzazepine-7,8-diol, 6-chloro-2,3,4,5- tetrahydro-1-(4-hydroxyphenyl)-, methanesulfonate (salt).C17H18ClNO3 · CH4SO3 415.89 to:6-Chloro-1-(4-hydroxyphenyl)-3-methyl-2,3,4,5- tetrahydro-1H-benzo[d]azepine-7,8-diol hydrochloride (N-Methyl-6-chloro-2,3,4,5-tetrahydro-1-(4- hydroxyphenyl)-1H-3-benzazepine-7,8-diol hydrochloride).C17H19ClNO3 · HCl 356.24

Halcinonide IMPURITIES/Organic Impurities/Chromatographic system

Line 1 of Column: Change1.8-µm packing L1 to:1.7-µm packing L1

Halcinonide Cream IMPURITIES/Organic Impurities/Chromatographic system


Line 1 of Column: Change1.8-µm packing L1to:1.7-µm packing L1

Hydromorphone Hydrochloride IMPURITIES/Organic Impurities/Procedure 2


Row 7 of column 1 of Table 4: Change7,8-Bishydromorphoneeto:7,8'-Bishydromorphonee

Isosorbide Dinitrate Extended-Release Capsules Assay


ChangeBuffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system?Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.to:Buffer solution?Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7.Mobile phase?Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature,dilute with water to 1000 mL, mix, degas,and filter. Make adjustments if necessary (see System Suitability underChromatography <621>). Internal standard solution?Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container. Standard preparation?Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solutionand 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter.AND ChangeProcedure: Proceed as directed for Procedure in theAssay under Diluted Isosorbide Dinitrate. to:Chromatographic system (see Chromatography<621>)?The liquid chromatograph is equipped with a220-nm detector and a 4-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injectionsdetermined from the peak response ratios is not more than 2%. [NOTE?The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.] Procedure?Separately inject equal volumes (about 20µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

http://www.usp.org/usp-nf/official-text/revision-bulletins






ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM2 Sujatha Ramakrishna Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016


USP Reference standards <11> CHM2 Donald Min Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Specific rotation <781> CHM2 Donald Min Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

CHM2 Donald Min Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017METHYLDOPA CHM2 Donald Min Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Moexipril Hydrochloride And Hydrochlorothiazide Tablets CHM2 Donald Min Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Naloxone Hydrochloride CHM2 Hillary Cai Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Naltrexone Hydrochloride Related compounds CHM2 Hillary Cai Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Nifedipine Extended-Release Tablets CHM2 Donald Min Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Norepinephrine Bitartrate CHEMICAL INFORMATION CHM2 Donald Min Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Olmesartan Medoxomil CHM2 Donald Min Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Simvastatin Tablets CHM2 Donald Min Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Sodium Nitroprusside Identification CHM2 Donald Min Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Isosorbide Dinitrate Extended-Release Tablets Assay


ChangeBuffer solution, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system?Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.to:Buffer solution?Dissolve 15.4 g of ammonium acetate in water, add 11.5 mL of glacial acetic acid, dilute with water to 1000 mL, and mix to obtain a solution having a pH of about 4.7.Mobile phase?Mix 350 mL of water, 100 mL of Buffer solution, and 550 mL of methanol. Cool to room temperature, dilute with water to 1000 mL, mix, degas, and filter. Make adjustments if necessary (see System Suitability under Chromatography <621>). Internal standard solution?Transfer a quantity of diluted nitroglycerin to a suitable volumetric flask, add about 60% of the flask volume of methanol, sonicate for 5 minutes, and shake for 30 minutes. Dilute with methanol to volume to obtain a solution having a concentration of about 3 mg of nitroglycerin per mL, and mix. Allow any undissolved material to settle, filter, and store the filtrate in an airtight container. Standard preparation?Transfer about 125 mg of recently mixed USP Diluted Isosorbide Dinitrate RS, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of Mobile phase, shake for 30 minutes, dilute with Mobile phase to volume, and mix. Pipet 10 mL of the resulting solution into a 25-mL volumetric flask, and add 4.0 mL of Internal standard solutionand 4 mL of dilute Buffer solution (1 in 10). Cool to room temperature, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.25 mg of isosorbide dinitrate per mL, based on the quantity of USP Diluted Isosorbide Dinitrate RS weighed and the labeled content of isosorbide dinitrate. Pass a portion of this solution through a 0.45-µm filter.AND Change Procedure: the resolution, R, between isosorbide dinitrate and nitroglycerin is not less than 2.0; and the relative standard deviation for replicate injectionsdetermined from the peak response ratios is not more than 2%. [NOTE?The relative retention times are about 0.75 for isosorbide dinitrate and 1.0 for nitroglycerin. The relative retention times for isosorbide mononitrates, if present, are about 0.38.] Procedure?Separately inject equal volumes (about 20µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Isosorbide Dinitrate Extended-Release TabletsDissolution<711>/Test 2


Line 1: ChangeBuffer solution and Mobile phase?Prepare as directed in the Assay under Diluted Isosorbide Dinitrate.to:Buffer solution and Mobile phase?Prepare as directed in the Assay.ANDLine 1 of Chromatographic system: Change(see Chromatography <621>)?Proceed as directed in the Assay under Diluted Isosorbide Dinitrate.to:(see Chromatography <621>)?Proceed as directed in the Assay.

Isosorbide Mononitrate Tablets


Line 2 of USP Diluted Isosorbide Mononitrate Related Compound A RS: Change1,4:3,5-Dianhydro-D-glucitol 2-nitrate. to:1,4:3,6-Dianhydro-D-glucitol 2-nitrate.

Ketorolac Tromethamine Injection ADDITIONAL REQUIREMENTS/USP Reference Standards <11>


Line 4 of USP Ketorolac Related Compound A RS: Change358.15to:358.39ANDLine 3 of USP Ketorolac Related Compound B RS: Change227.09to:227.26ANDLine 3 of USP Ketorolac Related Compound C RS: Change225.09to:225.24ANDLine 3 of USP Ketorolac Related Compound D: Change211.1to:211.3

Lovastatin


Line 2 of USP Lovastatin Related Compound A RS: Change[Dihydro-lovastatin][butanoic acid, 2-methyl-, 1,2,3,4,4a,7,8,8a-octahydro-3,7-dimethyl-8-[2(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1?(R*),3?,7?,8?(2S*,4S*),-8??]]]-.to:(1S,3S,4aR,7S,8S,8aS)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,4,4a,7,8,8a-octahydronaphthalen-1-yl (S)-2-methylbutanoate.

Mannitol Injection


Line 1: ChangeTransfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a 100-mL volumetric flask:it meets the requirements of the test for Specific rotation under Mannitol.to:+137° to +145°.Transfer an accurately measured volume of Injection, equivalent to about 1 g of mannitol as determined by the Assay, to a100-mL volumetric flask. Add 40 mL of a 1-in-10 ammonium molybdate solution, previously filtered if necessary. Add 20 mL of 1 Nsulfuric acid, and dilute with water to volume.

METHYLDOPA ASSAY/Proc edure/Chro matographic system USP41-NF36

Line 1 of Injection volume: Change1 mLto:20 µL

ASSAY/Procedure/Chromatographic system Line 1 of Injection volume: Change 1 mL to: 20 µL

IMPURITIES/OrganicImpurities


Row 6 of Column 2 of Table 5: Change0.62 to:0.82

IMPURITIES/Noroxymorphone Hydrochloride [(−)-4,5α-Epoxy-3,14- Dihydroxymorphinan-6- one-hydrochloride] and Other Impurities/Chromatograp hic system


AddApplication volume: 5 µL

USP 40-NF 35 (Online & Print)

Line 5: Change10F(C/W)(rU / rS)to:1000F(C/W)(rU/rS)

PERFORMANCE TESTS/Dissolution <711>/Test 9


Line 4 of Medium: Change6 g/Lto:10 g/L


Line 6: Change [69815-49-2]. to:[108341-18-0].



Footnote d of Impurity Table: Change(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2- propyl-1-((2'-(2-trityl-1H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H- imidazole-5-carboxylate.to:(5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2- propyl-1-((2'-(2-trityl-2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-1H- imidazole-5-carboxylate.

IMPURITIES/Organic Impurities/Analysis


Line 5: ChangeResult = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100to:Result = (rU/rS) × (CS/CU)× 100ANDDelete the variable definitions for Mr1 and Mr2.


Line 1 of Identification C: ChangeA solution (1 in 4) responds to the flame test for Sodium <191>.to:A solution (1 in 4) imparts an intense yellow color to a nonluminous flame.








Sulindac Tablets CHM2 Hillary Cai Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Terazosin Tablets CHM2 Donald Min Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Terazosin Tablets CHM2 Donald Min Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CHM2 Donald Min Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

CHM2 Donald Min Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

TIMOLOL MALEATE CHM2 Donald Min Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

TIMOLOL MALEATE CHM2 Donald Min Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Adapalene Gel CHM3 Feiwen Mao Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

BETAXOLOL OPHTHALMIC SOLUTION IMPURITIES/Organic Impurities CHM3 Ramanujam Prasad Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Brinzolamide CHM3 Ramanujam Prasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Brinzolamide Ophthalmic Suspension CHM3 Ramanujam Prasad Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Calcipotriene Ointment CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

CHM3 Feiwen Mao Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

DOCETAXEL CHM3 Feiwen Mao Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

CHM3 Andrea Carney Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

GLUCONOLACTONE CHM3 Andrea Carney Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Granisetron Hydrochloride USP Reference standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Granisetron Hydrochloride Injection USP Reference standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Granisetron Hydrochloride Injection CHM3 Andrea Carney Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Granisetron Hydrochloride Tablets USP Reference standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Granisetron Hydrochloride Tablets CHM3 Andrea Carney Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017



Line 1 of System suitability/Relative standard deviation: ChangeNMT 2.0% for any peakto:NMT 2.0% for sulindac, sulindac related compound B, and sulindac related compound CANDLine 3 of Analysis: ChangeCalculate the percentage of the labeled amount of sulindac related compound A, sulindac related compound B, or sulindac related compound C in the portion of Tablets taken:to:Calculate the percentage of sulindac related compound B or sulindac related compound C in the portion of Tablets taken:ANDLine 8 of Analysis: ChangerU = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Sample solutionto:rU = peak response of sulindac related compound B or sulindac related compound C from the Sample solutionANDLine 12 of Analysis: ChangerS = peak response of sulindac related compound A, sulindac related compound B, or sulindac related compound C from the Standard solutionto:rS = peak response of sulindac related compound B or sulindac related compound C from the Standard solution

IMPURITIES/OrganicImpurities/Procedure

Line 1 of Sample solution: ChangeTransfer 15 mg of the powder from the crushed Tabletsto:Transfer a suitable amount of powder, equivalent to 15 mg of terazosin hydrochloride, from the crushed Tablets

ASSAY/Procedure

Line 3 of System suitability solution: ChangeStandard solutionto:Standard stock solution

TIMOLOL MALEATE IDENTIFICA TION/B. USP41-NF36

Line 1: Changemajor peak of the Sample solution corresponds to that of the Standard solution, to:timolol peak of the Sample solution corresponds to that of the System suitability solution,

TIMOLOL MALEATEIMPURITIES/Enantiomer ic Purity USP41-NF36

Line 6 of Chromatographic system: DeleteAutosampler temperature: 4°

IMPURITIES/Enantiomeric PurityLine 6 of Chromatographic system: DeleteAutosampler temperature: 4°

IDENTIFICATION/B.

Line 1: Changemajor peak of the Sample solution corresponds to that of the Standard solution,to:timolol peak of the Sample solution corresponds to that of the System suitability solution,

ASSAY/Procedure

Line 5 of Sample stock solution: ChangeCool to room temperature and dilute with Diluent to volume.to:Cool to room temperature and dilute with Mobile phase to volume.


Line 14 of Analysis: ChangeMr1 = molecular weight of betaxolol hydrochloride, 343.89Mr2 = molecular weight of betaxolol, 307.43to:Mr1 = molecular weight of betaxolol, 307.43Mr2 = molecular weight of betaxolol hydrochloride, 343.89

ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Line 2 of USP Brinzolamide Related Compound B RS: Change(R-4-Amino)-2,3-dihydro-2- (3-methoxypropyl)-4H- thieno[3,2,-e]-thiazine-6- sulfonamide-1,1-dioxide ethandioate 1:1.to:(R)-4-Amino-2-(3- methoxypropyl)-3,4-dihydro-sulfonamide 1,1-dioxide oxalate.2H-thieno[3,2- e][1,2]thiazine-6-


Line 2 of USP Brinzolamide Related Compound B RS: Change(R-4-Amino)-2,3-dihydro-2- (3-methoxypropyl)-4H- thieno[3,2,-e]-thiazine-6- sulfonamide-1,1-dioxide ethandioate 1:1.to:(R)-4-Amino-2-(3- methoxypropyl)-3,4-dihydro-2H-thieno[3,2- e][1,2]thiazine-6- sulfonamide 1,1-dioxide oxalate.



Footnote a of Table 1: Change(5Z,7Z,22E,24R)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1?,3?,24-triol. to:(5Z,7Z,22E,24S)-24-Cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1?,3?,24-triol.

DOCETAXELIMPURITIES/Organic Impurities, Procedure 1 USP41-NF36

Footnote c of Table 2: Change(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b- Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with

IMPURITIES/Organic Impurities, Procedure 1

Footnote c of Table 2: Change(2aR,4R,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-formyl-3-phenylisoserine.to:(2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS) 12b Acetoxy 9 (((2R,3S) 3 formamido 2 hydroxy 3 phenylpropanoyl)oxy) 4,6,11‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐trihydroxy 4a,8,13,13 tetramethyl 5 oxo 2a,3,4,4a,5,6,9,10,11,12,12a,12b dodecahydro 1H 7,11‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐methanocyclodeca[3,4]benzo[1,2 b]oxet-12 yl benzoate.‐ ‐ANDFootnote d of Table 2: Change(2aR,4R,4aS,6R,9S,11S,12S,12aR,12bS)-6-{[(2,2-Dichloroethoxy)carbonyl]oxy}-1,2a,3,4,4a,6,9,10,11,12,12a,12b-dodecahydro-4,9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b)oxet-5-one 12b-acetate, 12-benzoate, 9-ester with (2R,3S)-N-tert-butoxycarbonyl-e-phenylisoserine.to: (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS) 6 {[(2,2 Dichloroethoxy)carbonyl]oxy} 1,2a,3,4,4a,6,9,10,11,12,12a,12b dodecahydro‐ ‐ ‐ ‐ ‐ ‐4,9,11,12,12b pentahydroxy 4a,8,13,13 tetramethyl 7,11 methano 5H cyclodeca[3,4]benz[1,2 b]oxet 5 one 12b acetate, 12‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐benzoate, 9 ester with (2R,3S) N tert-butoxycarbonyl 3 phenylisoserine.‐ ‐ ‐ ‐ ‐

GLUCONOLAC TONE ASSAY/Proc edure USP41-NF36

Line 5 of Analysis: ChangeEach mL of Back-titrantto:Each milliliter of Titrant

ASSAY/Procedure

Line 5 of Analysis: Change Each mL of Back-titrantto:Each milliliter of Titrant


Line 2 of USP Granisetron Related Compound B RS: Change(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).to:(N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).ANDLine 2 of USP Granisetron Related Compound E RS: Change((1R,3rS,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).to:((1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]nonan-3-amine, acetate salt).


Line 2 of USP Granisetron Related Compound B RS: Change(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).to:N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.

USP Reference standards<11> USP41-NF36

Line 3 of USP Granisetron Related Compound C RS: Change carboxamide.to: carboxamide hydrochloride.


Line 2 of USP Granisetron Related Compound B RS: Change(N-[(1R,3r,5)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide).to:N-[(1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide.

USP Reference standards<11> USP41-NF36

Line 3 of USP Granisetron Related Compound C RS: Change carboxamide.to: carboxamide hydrochloride.

Isotretinoin Capsules CHM3 Feiwen Mao Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Metformin Hydrochloride Extended- Release Tablets CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

CHM3 Feiwen Mao Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

Mycophenolate Mofetil CHM3 Feiwen Mao Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Mycophenolate Mofetil For Injection CHM3 Feiwen Mao Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Mycophenolate Mofetil For Injection CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Mycophenolate Mofetil For Oral Suspension CHM3 Feiwen Mao Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION CHM3 Feiwen Mao Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Mycophenolate Mofetil For Oral Suspension CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Mycophenolate Sodium CHM3 Feiwen Mao Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Mycophenolate Sodium CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Mycophenolate Sodium CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Olopatadine Hydrochloride Ophthalmic Solution CHM3 Ramanujam Prasad Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Pemetrexed Disodium CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Pemetrexed for Injection CHM3 Feiwen Mao Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

CHM3 Andrea Carney Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS CHM3 Andrea Carney Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Ranitidine In Sodium Chloride Injection ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Ranitidine Injection ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Ranitidine Oral Solution ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Ranitidine Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Rivastigmine ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Rivastigmine CHM3 Elena Gonikberg Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Rivastigmine Tartrate ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Rivastigmine Tartrate CHM3 Elena Gonikberg Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Rivastigmine Tartrate Capsules ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016


Row 1 of Column 1 of Table1: Change Tablet Strength to:Capsule Strength

PERFORMANCE TESTS/Dissolution <711>USP 40-NF 35 (Online & Print)

Line 3 of Test 3: ChangeMedium, Apparatus 1, Apparatus 2, and Analysis:to:Medium, Apparatus 1, and Apparatus 2:

MYCOPHENOL ATE MOFETIL FOR ORAL SUSPENSION ASSAY/Proc edure USP41-NF36

Line 3 of Sample solution: Change45-µm pore size. to:0.45-µm pore size.

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41-NF36Line 5 of USP Mycophenolate Mofetil Related Compound A RS: ChangeC23H31NO7 to: C22H29NO7

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41-NF36Line 5 of Mycophenolate Mofetil Related Compound A RS:Change C23H31NO7 to: C22H29NO7



Line 2 of USP Mycophenolate Mofetil RelatedCompound B RS: Change(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H- isobenzofuranyl-1-one.to:(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41-NF36Line 5 of Mycophenolate Mofetil Related Compound A RS: ChangeC23H31NO7 to: C22H29NO7

ASSAY/Procedure

Line 3 of Sample solution: Change 45-µm pore sizeto:0.45-µm pore size.





Line 3: ChangeSolvent A to: Solution A ANDLine 5: ChangeSolvent B to: Solution B






Footnote a of Table 2: Change(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H- isobenzofuranyl-1-one. to:(RS)-7-Hydroxy-5-methoxy-4-methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-isobenzofuran-1-one.

IMPURITIES/Limit of Late Eluting Impurities


Add[Note-Protect solutions from light.]



Footnote b: Change{4-[2-(2-Amino-1-methyl-4-oxo-4,7-dihydro-1H- pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-4-L- glutamyl-L-glutamic acid.to:{4?[2?(2?Amino?4?oxo?4,7?dihydro?1H?pyrrolo[2,3?d]pyrimidin?5?yl)ethyl]benzoyl}?4?L?glutamyl?L?gluta mic acid.

ASSAY/Procedure/Analysis


In the variable definition list: ChangeMr2 = molecular weight of pemetrexed disodium,597.49to:Mr2 = molecular weight of pemetrexed disodium(anhydrous), 473.37

PIOGLITAZON E AND METFORMIN HYDROCHLORI DE TABLETS

PERFORMAN CE TESTS/Disso lution<711>/Test2 USP41-NF36

Line 3 of Standard solution: ChangeUSP Metformin Hydrochloride RS in Diluent Ato:USP Metformin Hydrochloride RS from the Metformin standard stock solution in DiluentA

PERFORMANCE TESTS/Dissolution <711>/Test 2

Line 3 of Standard solution: ChangeUSP Metformin Hydrochloride RS in Diluent A to:USP Metformin Hydrochloride RS from the Metformin standard stock solution in Diluent A


Line 2 of USP Ranitidine Related Compound C RS: ChangeN-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine. to:N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N'-methyl-2-nitro-1,1-ethenediamine.




Line 2 of USP Ranitidine Related Compound C RS: ChangeN-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N-methyl-2-nitro-1,1-ethenediamine.to:N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N'-methyl-2-nitro-1,1-ethenediamine.




Line 2 of USP Rivastigmine Related Compound B RS: ChangeNor impurity;(S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate. to:Nor impurity (racemic mixture);(RS) 3 [1 (Dimethylamino)ethyl]phenyl dimethylcarbamate.‐ ‐ ‐



Row 3 of Column 1 of Table 1: ChangeNor impurity (rivastigmine related compound B)to:Nor impurityaANDAdd footnote a:a(S) 3 [1 (Dimethylamino)ethyl]phenyl dimethylcarbamate (racemic‐ ‐ ‐mixture is rivastigmine related compound B).


Line 2 of USP Rivastigmine Related Compound B RS: ChangeN,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to:(RS) 3 [1 (Dimethylamino)ethyl]phenyl dimethylcarbamate.‐ ‐ ‐

IMPURITIES/Organic Impurities/Procedure 1


Footnote c of Impurity Table 1: Change(S)-3-[1-(Dimethylamino)ethyl]phenyl dimethylcarbamate(rivastigmine related compound B). to:(S) 3 [1 (Dimethylamino)ethyl]phenyl dimethylcarbamate (racemic‐ ‐ ‐mixture is rivastigmine related compound B).


Line 2 of USP Rivastigmine Related Compound B RS: ChangeN,N-Dimethylcarbamic acid-3-[1-(dimethylamino)ethyl]phenyl ester. to:(RS) 3 [1 (Dimethylamino)ethyl]phenyl dimethylcarbamate.‐ ‐ ‐

Tamsulosin Hydrochloride Capsules CHM3 Elena Gonikberg Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Trospium Chloride ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM3 Elena Gonikberg Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Vinorelbine Injection CHM3 Feiwen Mao Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Vinorelbine Tartrate CHM3 Feiwen Mao Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Almotriptan Tablets CHM4 Heather Joyce Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Alprazolam Extended-Release Tablets CHM4 Heather Joyce Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Atropine Sulfate CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Atropine Sulfate CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Bupropion Hydrochloride CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CARBIDOPA ASSAY/Procedure CHM4 Heather Joyce Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

CYCLOBENZAPRINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM4 Heather Joyce Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Cyclobenzaprine Hydrochloride Tablets CHM4 Heather Joyce Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Dextroamphetamine Sulfate CHM4 Heather Joyce Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Diazepam Injection Assay CHM4 Heather Joyce Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Donepezil Hydrochloride CHM4 Heather Joyce Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Ethotoin CHM4 Heather Joyce Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Felbamate Oral Suspension CHM4 Heather Joyce Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Fluorescein Sodium CHM4 Ramanujam Prasad Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Fluticasone Propionate And Salmeterol Inhalation Powder CHM4 Ravi Ravichandran Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Fluvoxamine Maleate CHM4 Heather Joyce Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017


Gadoteridol CHM4 Ravi Ravichandran Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Galantamine Extended- Release Capsules CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Galantamine Extended- Release Capsules CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CHM4 Heather Joyce Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

ASSAY/Procedure 8


Line 1 of Standard solution: ChangePrepare a solution containing 1.0 mg/mL of USP TamsulosinHydrochloride RS in methanol. to:Prepare a solution containing 0.1 mg/mL of USP TamsulosinHydrochloride RS in methanol. ANDLine 6 of Sample solution: ChangeAdd 30 mL of Mobile phase, and shake by mechanical means for 30 min.to:Add 30 mL of Mobile phase, shake by mechanical means for 30 min, and dilute with Mobile phase to volume.


Line 3 of USP Trospium Chloride Related Compound C RS:Change (1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'- pyrrolidinium] chloride.to:(1R,3r,5S)-3-Hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'- pyrrolidinium] chloride, or (1R,3r,5S)-3- Hydroxyspiro[bicyclo[3.2.1]octane-8,1'-pyrrolidin]-1'-ium chloride.

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP41-NF36

Line 2 of USP Vinorelbine Related Compound A RS: Change4-O- Deacetylvinorelbine. to:4-O- Deacetylvinorelbine tartrate.


Line 2 of USP Vinorelbine Related Compound A RS: Change4-O- Deacetylvinorelbine. to:4-O- Deacetylvinorelbine tartrate


Line 4 of USP Almotriptan Related Compound B RS: Change½C4H4Oto:½C4H4O4

PERFORMANCE TESTS/Dissolution<711>USP 40-NF 35 (Online & Print)

Variable definition list of second equation in Test 2/Analysis: Change VS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)to:VS = volume of the Sample solution withdrawn at each time point (mL) ANDVariable definition list of second equation in Test 3/Analysis: ChangeVS = volume of the Sample solution withdrawn at each time point and replaced with Medium (mL)to:VS = volume of the Sample solution withdrawn at each time point (mL)

ASSAY/Procedure

Line 4 of Analysis: Change(C17H23NO32 · H2SO4)to:[(C17H23NO3)2 · H2SO4]

DEFINITIONLine 2: Change (C17H23NO32 · H2SO4), to:[(C17H23NO3)2 · H2SO4],

IMPURITIES/Organic ImpuritiesRow 9 of Column 1 of Table3: Change Bromochloropropionphenonee to: Bromochloropropiophenonee


Line 3: ChangeMobile phase: Alcohol and 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7 (5:95) to:Buffer: 0.05 M monobasic sodium phosphate, adjusted with phosphoric acid to a pH of 2.7Mobile phase: Alcohol and Buffer (5:95)


Line 2 of USP Cyclobenzaprine Related Compound B RS: Change3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine.C19H19N 261.36 to: 3-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine hydrochloride.C19H19N · HCl 297.82

IMPURITIES/OrganicImpurities/Analysis


Line 3: ChangeCalculate the percentage of any individual unspecified degradation productto:Calculate the percentage of any individual degradation productANDLine 6: ChangerU = peak response of any individual unspecified degradation product from the Sample solutionto:rU = peak response of any individual degradation product from theSample solution

ASSAY/Procedure


Line 1 of System suitability solution: Change0.02 µg/mL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS in Standard solutionto:Transfer about 40 mL of the Standard solution to a 50-mL volumetric flask. Using a microliter syringe, add 1 µL each of USP Dextroamphetamine Related Compound A RS and USP Dextroamphetamine Related Compound B RS. Dilute with Standard solution to volume.


Line 7 of Procedure:50C / V(RU / RS)to:50(C / V)(RU / RS)

IMPURITIES/Organic Impurities/Procedure 2


Footnote h of Table 3: Change1-Benzyl-4-[(5,6-dimethoxyindan-2-yl)methyl]piperidine. to:1-Benzyl-4-[(5,6-dimethoxyinden-2-yl)methyl]piperidine.

Related compounds/Procedure


Line 11:Changeweight, in mg, on the anhydrous basis, of the portion of Ethotoin taken;to:weight, in mg, of the portion of Ethotoin taken;

PERFORMANCE TESTS/Dissolution <711>


Line 4 of System suitability: Change[Note?The relative retention times for methylparaben and felbamate are about 0.5 and 1.0, respectively.]to:[Note?The relative retention times for felbamate and methylparaben are about 1.0 and 1.5, respectively.]



Row 7 of column 1 of Table 2: ChangeTotal impuritiesto:Total unspecified impurities


Line 3 of System suitability: Changefor salmeterol and fluticasone propionate are to:for fluticasone propionate and salmeterol are

CHEMICAL INFORMATION


Line 4:Change5-Methoxy-4?-(trifluoromethyl)valerophenone (E)-O- (2-aminoethyl)oxime, maleate (1:1)to:(E)-5-Methoxy-4?-(trifluoromethyl)valerophenone O- (2-aminoethyl)oxime, maleate (1:1)



Footnote b:Change5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone(E)-O-[2-[(2-succinyl)amino]ethyl]oxime. to:(E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1- pentanone O-[2-[(2-succinyl)amino]ethyl]oxime. ANDFootnotes c- g: Delete the space before oxime

Chromatographic purity/Test 2 (Nongadolinium- Containing Impurities)


Line 1 of pH 5.0 Buffer: Change50 mM Ammoniumto:50 mM Ammonium phosphate bufferANDLine 1 of pH 7.0 Buffer: Change50 mM Ammoniumto:50 mM Ammonium phosphate buffer


Line 2 of Standard solution: Change(equivalent to 0.02 of galantamine)to:(equivalent to 0.02 mg/mLof galantamine)


Line 1of Buffer: Change To each L of 6.8-g/L potassium phosphate to:To each L of 6.8 g/L of monobasic potassium phosphate

Galantamine Hydrobromide IMPURITIES/Organic Impurities


Line 8 of Analysis: ChangeResult = (rU/rS) × (CS/CU) × (1/F) × (100/100 - L)to:Result = (rU/rS) × (CS/CU) × (1/F) × (100/[100 - L])




ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM4 Jeanne Sun Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

CHM4 Heather Joyce Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CHM4 Ravi Ravichandran Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

CHM4 Ravi Ravichandran Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

CHM4 Ren-Hwa Yeh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

CHM4 Ren-Hwa Yeh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM4 Ren-Hwa Yeh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016



CHM4 Mary Koleck Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

CHM4 Mary Koleck Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017


CHM4 Mary Koleck Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM4 Gerald Hsu Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

CHM4 Gerald Hsu Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

CHM4 Galina Holloway Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

CHEMICAL INFORMATION CHM4 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

CHM4 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM4 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

CHM4 Kalyana Seela Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

CHM4 Kalyana Seela Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Assay CHM4 Kalyana Seela Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016


PERFORMANCE TESTS/Dissolution <711>/Test 1 CHM4 K. Kalyana Seela Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Galantamine Tablets PERFORMANCE TESTS/Dissolution


Line 6 of Analysis in Test 1: ChangeResult = (AU/AS) × (CS/L) × (Mr1/Mr2) × 100 to:Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × V × 100ANDAdd to the variable definition list in Test 1V = volume of Medium, 500 mL ANDEquation in Test 3: ChangeResult = (rU/rS) × (CS/L) × (Mr1/Mr2) × 100 to:Result = (rU/rS) × (CS/L) × (Mr1/Mr2) × V × 100ANDAdd to the variable definition list in Test 3V = volume of Medium, 500 mL

Haloperidol Decanoate IMPURITIES/Organic Impurities/Table 2


Footnote k: Change4-(4'-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.to:4-(3'-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.ANDFootnote l: Change4-(3'-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.to:4-(4'-Chlorobiphenyl-4-yl)-1-[4-(4-fluorophenyl)-4-oxobutyl]piperidin-4-yl decanoate.

Hydroxyzine Pamoate Oral Suspension


DeleteUSP Hydroxyzine Hydrochloride RS

Imipramine Pamoate CapsulesPERFORMANCE TESTS/Dissolution<711>/Test 1

Line 6 of Analysis: Change Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × V x (1/L) × 100 to:Resulti = (ri/rs) × Cs × [M × (Mr1/Mr2)] × D × V × (1/L) ×100 ANDTo the variable definition list in Analysis: AddD = dilution factor of theSample solution

IOHEXOLIMPURITIES/Limit of Free Iodide/Analy sis USP41-NF36

Line 3 of variable definition list: Change0.1269 mg/mEq to:126.9 mg/mEq

IOHEXOL IMPURITIES/Limit of Free Iodide/Analysis

Line 3 of variable definition list: Change 0.1269 mg/mEq to:126.9 mg/mEq

Levetiracetam Extended- Release TabletsPERFORMANCE TESTS/Dissolution<711>/Test 7

Line 2 of Standard solution: ChangeBuffer A. to: Medium.

Lorazepam ADDITIONAL REQUIREMENTS/USP Reference Standards <11>USP 40-NF 35 (Online & Print)

Line 3 of USP Lorazepam Related Compound B RS: ChangeC13H9ClNO to: C13H9Cl2NO

Lorazepam InjectionUSP 40-NF 35 (Online & Print)

Line 3 of Lorazepam Related Compound B RS: ChangeC13H9ClNO to: C13H9Cl2NO

Lorazepam Oral ConcentrateUSP 40-NF 35 (Online & Print)

Line 3 of Lorazepam Related Compound B RS: ChangeC13H9ClNO to: C13H9Cl2NO

Lorazepam TabletsUSP 40-NF 35 (Online & Print)

Line 3 of USP Lorazepam Related Compound B RS: ChangeC13H9ClNO to: C13H9Cl2NO

Memantine Hydrochloride Tablets IMPURITIES/Organic ImpuritiesUSP 40-NF 35 (Online & Print)

Line 3 of Analysis: Changeof USP Memantine Related Compound E RS or to:of memantine related compound E orANDIn the variable definition list: ChangerU = peak response of USP Memantine Related Compound E RS or any individual degradation product from the Sample solutionto:rU = peak response of memantine related compound E or any individual degradation product from the Sample solution

Memantine Hydrochloride Tablets PERFORMANCE TESTS/Dissolution <711>/Analysis


In the variable definition list: ChangeCS = concentration of USP Memantine HydrochlorideRS in the Standard solution (µg/mL)to:CS = concentration of USP Memantine HydrochlorideRS in the Standard stock solution (mg/mL)

Metaxalone TabletsPERFORMANCE TESTS/Dissolution<711>


Line 2 of Buffer, Mobile phase, Chromatographic system, and System suitability: ChangeProceed as directed in the Assay. to:Proceed as directed in the Assay, except use 270 nm for analysis. ANDLine 10 of Analysis: ChangeV = volume of the Medium, 750 mLto:V = volume of the Medium, 900 mL

Methacholine Chloride ASSAY/Procedure/Chromatographic system

Line 1 of Columns/Guard and Columns/Analytical: Change L771to: L77ANDLine 1 of Suppressor: Change autosuppressor2to:autosuppressor1ANDDelete footnote 1ANDRenumber footnote 2 as footnote 1

Nicotine PolacrilexUSP 40-NF 35 (Online & Print)

AddUSP Polacrilex Resin RS

ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE TABLETS IMPURITIES/Organic Impurities

Line 1 of System suitability solution: Change USP Salicyclic Acid RS to:USP Salicylic Acid RS

Oxazepam SPECIFIC TESTS/pH <791>


Line 1: ChangeSample solution: 20 mg/mLto:Sample: A suspension of 1 g of Oxazepam in 50 mL water

PaliperidoneUSP 40-NF 35 (Online & Print)

Line 5: Change(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4- oneto:(9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4- one

Paliperidone IMPURITIES/Organic Impurities/System suitability/Suitability requirementsUSP 40-NF 35 (Online & Print)

Line 3 of Resolution: Change hydroxybenzylto:hydroxybenzoyl

Paroxetine Extended-Release TabletsUSP 40-NF 35 (Online & Print)

USP Paroxetine Related Compound B RS: AddC19H21NO3 · HCl 347.84

PHENYTOIN ORAL SUSPENSION

IMPURITIES/OrganicImpurities USP41-NF36

Line 1 of Sample solution: Change1 mg/mL of Oral Suspension in Diluentto:Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.

PHENYTOIN ORAL SUSPENSION IMPURITIES/Organic Impurities

Line 1 of Sample solution: Change1 mg/mL of Oral Suspension in Diluent to:Nominally 1 mg/mL of phenytoin prepared as follows. Weigh and transfer a suitable volume of Oral Suspension to an appropriate volumetric flask. Add methanol to about 20% of the final flask volume and dissolve. Dilute with Diluent to volume. Dissolve with the aid of sonication, if necessary.

Risperidone Tablets


Line 4 of Procedure: ChangeCalculate the quantity, in mg, of risperidone to:Calculate the percentage of the labeled amount of risperidone

Rizatriptan Benzoate Tablets PERFORMANCE TESTS/Dissolution <711>/Chromatographic procedure


AddBuffer: 1.36 g/L of monobasic potassium phosphate. Adjust the pH of the solution with phosphoric acid to 2.5.

ROPINIROLE EXTENDED-RELEASE TABLETS


Line 2 of Buffer 1: Adjust with Solution A to a pH of 4.0. to: Adjust with Solution A to a pH of 4.0. Dilute with water to 1 L.



























CHM4 Kahkashan Zaidi Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017


Other requirements CHM4 Ravi Ravichandran Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Assay CHM4 Sridevi Ramachandran Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Assay CHM4 Sridevi Ramachandran Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016








Dexamethasone Sodium Phosphate Injection CHM5 Morgan Puderbaugh Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Dexamethasone Sodium Phosphate Ophthalmic Solution CHM5 Morgan Puderbaugh Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Diphenhydramine Hydrochloride Injection CHM5 Morgan Puderbaugh Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Drospirenone And Ethinyl Estradiol Tablets CHM5 Mary Koleck Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Ropinirole Extended-Release TabletsIMPURITIES/OrganicImpurities/Analysis USP41-NF36

Line 8 of the variable definition list of the first equation: Change CU = nominal concentration of ropinirole related compound B free base in the Sample solution (µg/mL) to:CU = nominal concentration of ropinirole in the Sample solution (µg/mL)

Ropinirole Tablets IMPURITIES/Organic Impurities


Footnote b of Table 2: Change4-[2-(Dipropylnitroryl)ethyl]-1,3-dihydrox-2H-indol-2-one. to: N-[2-(2-Oxoindolin-4-yl)ethyl]-N-propylpropan-1-amine oxide.

Samarium Sm 153 Lexidronam InjectionUSP 40-NF 35 (Online & Print)

Line 1: ChangeInjections and Implanted Drug Products <1>; not subject to ContainerContent. to:Meets the requirements of Injections and Implanted Drug Products<1>; not subject to Container content.

Trihexyphenidyl Hydrochloride Extended-Release Capsules


Line 1 of Mobile phase and Chromatographic system: ChangePrepare as directed in the Assay under Trihexyphenidyl Hydrochloride.to:Mobile phase?Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and dElena Gonikbergas. Make adjustments if necessary (see System Suitability under Chromatography <621>).Chromatographic system (see Chromatography <621>)?The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-µm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.ANDLine 1 of Procedure: ChangeProceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.to:Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.ANDLine 6 of Procedure: Changeand the other terms are as defined therein.to:C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, rU and rS are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Trihexyphenidyl Hydrochloride Oral Solution


Line 1 of Mobile phase and Chromatographic system: ChangePrepare as directed in the Assay under TrihexyphenidylHydrochloride.to:Mobile phase?Prepare a mixture of acetonitrile, water, and triethylamine (920:80:0.2), adjust with phosphoric acid to a pH of 4.0, mix, filter, and dElena Gonikbergas. Make adjustments if necessary (see System Suitability under Chromatography <621>).Chromatographic system (see Chromatography <621>)?The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm × 8-cm column that contains 3-µm packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates, the tailing factor for the analyte peak is not more than 3.0, and the relative standard deviation for replicate injections is not more than 1.0%.ANDLine 1 of Procedure: ChangeProceed as directed for Procedure in the Assay under Trihexyphenidyl Hydrochloride.to:Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks.ANDLine 7 of Procedure: Changeand the other terms are as defined therein.to:C is the concentration, in mg per mL, of USP Trihexyphenidyl Hydrochloride RS in the Standard preparation, rU and rS are the trihexyphenidyl peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Aminophylline ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Line 2 of USP Theophylline Related Compound D RS: ChangeN-Methyl-5-(methylamino)-1H-imidazole-4- carboxamide. C6H10N4O 154.17 to: Theophyllidine;N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate. C6H10N4O · HCl · H2O 208.65

Aminophylline Injection ADDITIONAL REQUIREMENTS/USP Reference Standards <11>


Aminophylline Oral Solution ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Line 2 of USP Theophylline Related Compound D RS: Change N-Methyl-5-(methylamino)-1H-imidazole-4- carboxamide. C6H10N4O 154.17 to: Theophyllidine;N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate. C6H10N4O · HCl · H2O 208.65

Aminophylline Tablets PERFORMANCE TESTS/Uniformity of Dosage Units <905>/Procedure for content uniformity

Variable definition for CU inAnalysis: Change(mg/mL) to: to:(µg/mL)

Aminophylline Tablets ADDITIONAL REQUIREMENTS/USP Reference Standards <11>


Clobetasol Propionate ASSAY/Procedure/System suitability/Suitability requirements

Line 2 of Column efficiency: Changeclobetasol peak to:clobetasol propionate peakANDLine 1 of Tailing factor: Changeclobetasol peak to:clobetasol propionate peak

Desloratadine Orally Disintegrating TabletsIMPURITIES/OrganicImpurities USP41-NF36

Line 5 of Sample solution: Change Add 70% of the flask volume of Mobile phaseto:Add 70% of the flask volume of Diluent

ASSAY/Procedure


Line 9 of Analysis: ChangeCS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)to:CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)

ASSAY/Procedure


Line 9 of Analysis: ChangeCS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (µg/mL)to:CS = concentration of USP Dexamethasone Sodium Phosphate RS in the Standard solution (mg/mL)


Line 1 of System suitability solution:ChangeUSP Diphenhydramine Hydrochloride Related Compound A RSto:USP Diphenhydramine Related Compound A RS ANDLine 4 of System suitability: Changefor diphenhydramine hydrochloride related compound A and diphenhydramine hydrochloride areto:for diphenhydramine related compound A and diphenhydramine are


Test 3: Delete the secondMobile phase













DUTASTERIDE IMPURITIES/Organic Impurities, Procedure 2/Table 4 CHM5 Mary Koleck Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Fexofenadine Hydrochloride CHEMICAL INFORMATION CHM5 Gerald Hsu Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Fluorometholone Ophthalmic Suspension CHM5 Gerald Hsu Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Ipratropium Bromide CHM5 Ravi Ravichandran Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Ipratropium Bromide DEFINITION CHM5 Ravi Ravichandran Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Methohexital CHEMICAL INFORMATION CHM5 Gerald Hsu Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Oxandrolone Tablets CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Promethazine Hydrochloride CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Promethazine Hydrochloride Injection CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Promethazine Hydrochloride Oral Solution CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Promethazine Hydrochloride Tablets CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016



SUCCINYLCHOLINE CHLORIDE INJECTION IDENTIFICATION CHM5 Ren-Hwa Yeh Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016



Bisoctrizole CHM6 Sujatha Ramakrishna Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Bisoctrizole CHM6 Sujatha Ramakrishna Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Brompheniramine Maleate CHM6 Alan Potts Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Chloroxylenol CHM6 Alan Potts Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016


Footnote a: Change(5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrost-17 carboxamide.to: (5α,17β)-N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-azaandrostane-17-carboxamide.


Line 7: Change[138452-21-8].to:[153439-40-8].

IDENTIFICATION/A. Infrared Absorption <197K>


Line 1 of Sample solution: ChangeLine 1 of Sample solution: ChangeOphthalmic Solutionto:Ophthalmic Suspension

ASSAY/Procedure


Line 4 of Analysis: Change(C20H30BrNO3 · H2O)to:(C20H30BrNO3)


Line 2: Change (C20H30BrNO3 · H2O) to:(C20H30BrNO3)


Line 5: Change [18652-93-2] to:[151-83-7]

Dissolution <711>/Test 3USP 40-NF 35 (Online & Print)

Line 3 of Chromatographic system: Change30-cm column to:3-cm column


Line 2 of USP Promethazine Related Compound B RS: ChangeIsopromethazine;N,N-Dimethyl-2-(10H- phenothiazin-10-yl)propan-1-amine. C17H20N2S 282.42 to: Isopromethazine hydrochloride;N,N-Dimethyl-2-(10H- phenothiazin-10-yl)propan-1-amine hydrochloride. C17H20N2S · HCl 320.88







Ropivacaine Hydrochloride


Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(-)-1- propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.to:(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1- propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.

Ropivacaine Hydrochloride Injection


Line 2 of USP Ropivacaine Related Compound B RS: Change (R)-ropivacaine hydrochloride monohydrate; (R)-(-)-1- propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.to:(R)-Ropivacaine hydrochloride monohydrate; (R)-(+)-1- propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide hydrochloride monohydrate.


Line 1: ChangeIt responds to Identification tests B and C under Succinylcholine Chloride. to:A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.B. Thin-Layer Chromatographic Identification Test <201>Standard solution: 1 mg/mL of USP Succinylcholine Chloride RS in waterSample solution: Nominally 1 mg/mL of succinylcholine chloride from Injection in waterChromatographic system(See Chromatography <621>, Thin-Layer Chromatography.)Adsorbent: 0.25-mm layer of chromatographic silica gelApplication volume: 1 µLDeveloping solvent system: Acetone and 1 N hydrochloric acid (1:1)AnalysisSamples: Standard solution and Sample solutionProceed as directed in the chapter. To locate the spots, heat the plate at 105° for 5 min, cool, and spray with potassium bismuth iodide TS, then heat again at 105° for 5 min.Acceptance criteria: Meets the requirements

Theophylline ADDITIONAL REQUIREMENTS/USP Reference Standards RS <11>

Line 3 of USP Theophylline Related Compound D RS: ChangeN-Methyl-5-(methylamino)-1H-imidazole-4- carboxamide. C6H10N4O 154.17 to:N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate. C6H10N4O · HCl · H2O 208.65

Theophylline Oral Solution ADDITIONAL REQUIREMENTS/USP Reference Standards <11>

Line 3 of USP Theophylline Related Compound D RS: ChangeN-Methyl-5-(methylamino)-1H-imidazole-4- carboxamide. C6H10N4O 154.17 to:N-Methyl-5-(methylamino)-1H-imidazole-4-carboxamide hydrochloride monohydrate. C6H10N4O · HCl · H2O 208.65



Line 2 of USP Bisoctrizole Resolution Mixture RS: ChangeA mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.to:A mixture of approximately 1.5% of bisoctrizole isomer [phenol, 2,2'-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)]] in a matrix of bisoctrizole.



Footnote b of Table 2: ChangePhenol, 2,2-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].to:Phenol, 2,2'-methylenebis[6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)].

SPECIFIC TESTS/Optical Rotation, Specific Rotation <781>


Line 1: Delete Specific Rotation ANDLine 1 of Sample: Change100 mg/mL in water to:100 mg/mL in water at 20°

IMPURITIES/Limit ofTetrachloroethylene


Row 3 of Column 1 of Table 2: Change210 to:70Row 3 of Column 2 of Table 2: Change0 to:35



http://www.usp.org/usp-nf/official-text/iras

http://www.usp.org/usp-nf/official-text/iras

Chlorpheniramine Maleate CHM6 Alan Potts Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

NAPHAZOLINE HYDROCHLORIDE IMPURITIES/Organic Impurities CHM6 Sujatha Ramakrishna Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Naproxen Sodium Tablets CHM6 Richard Nguyen Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Naproxen Tablets CHM6 Richard Nguyen Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Naproxen Tablets CHM6 Richard Nguyen Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Simethicone CHM6 Michael Chang Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

<800> Hazardous Drugs—Handling In Healthcare Settings CMP Jeanne Sun Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Hydrochloric Acid Injection CMP Jeanne Sun Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Ringer's Injection CMP Jeanne Sun Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

GUAR GUM ASSAY/Content of Galactomannan and Ratio of Constituting Mannose and Galactose EXC Hong Wang Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

POVIDONE IMPURITIES/Formic Acid EXC Kevin Moore Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

EXC1 Galina Holloway Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Cetyl Alcohol EXC1 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Fumaric Acid EXC1 Galina Holloway Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016

Light Mineral Oil EXC1 Hong Wang Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Magnesium Aluminometasilicate EXC1 Galina Holloway Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Magnesium Aluminum Silicate EXC1 Galina Holloway Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Methacrylic Acid And Ethyl Acrylate Copolymer EXC1 Hong Wang Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Monobasic Potassium Phosphate EXC1 Galina Holloway Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Myristyl Alcohol EXC1 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Oleyl Alcohol EXC1 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

SPECIFIC TESTS/Optical Rotation, Specific Rotation <781>


Line 1: DeleteSpecific Rotation


Line 16 of Analysis: ChangeCalculate the percentage of any individual unspecified impurityto:Calculate the percentage of any other individual impurityANDLine 20 of Analysis: ChangerU = peak response of any individual unspecified impurity to:rU = peak response of any other individual impurity



Line 6 of Analysis: ChangeResult = (rU/rS) × (CU/CS) × 100to:Result = (rU/rS) × (CS/CU) × 100



Line 6 of Analysis: ChangeResult = (rU/rS) × (CU/CS) × 100to:Result = (rU/rS) × (CS/CU) × 100

ASSAY/Procedure/System suitability/Suitability requirements


Line 1 of Tailing factor: ChangeNLT 2.0to:NMT 2.0

ASSAY/Procedure/Analysis


Line 1 of Samples: ChangeStandard stock solution, Standard solution, Sample stock solution, and Sample solutionto:Standard solution and Sample solution

5. FACILITIES AND ENGINEERING CONTROLS/5.3 CompoundingUSP 40-NF 35 (Online & Print)

First bullet in second paragraph: Change• Be externally vented through high-efficiency particulate air (HEPA)filtration to:• Be externally vented

ASSAY/Procedure


Line 8 of Analysis: Change F = equivalency factor, 18.23 mg/mEqto:F = equivalency factor, 36.46 mg/mEq

ASSAY USP41-NF36

Line 1 of Calcium/Instrument al conditions/Mode: Change spectrophotometer to: spectrophotometry ANDLine 1 of Potassium/Solution A: ChangeSuitable wetting agentto:Suitable nonionic wetting agent


Line 4 of Analysis: ChangeStandard solution B to:Sample solution B


Line 3 of Sample solution: Changecolumn of about 80 mmto: column of about 8 mm

<1197> Good Distribution Practices for Bulk Pharmaceutical Excipients SECTION 3: PREMISES, STORAGE, REPACKAGING, AND STABILITY

Line 1 of paragraph 2 of 3.6Expiration Dates: Delete (see Nuclear Magnetic Resonance Spectroscopy<761>)

IMPURITIES/Limit of Related Fatty AlcoholsUSP 40-NF 35 (Online & Print)

Line 1 of Sample solution: Change1 mg/mL of Cetyl Alcohol in ethanol to:Prepare 1.0 mg/mL of Cetyl Alcohol in ethanol, and heat the solution in a sealed container in a 50° water bath until cetyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.

SPECIFIC TESTS/Water Determination, Method I <921>


Line 1: Change0.50%to:NMT 0.5%

SPECIFIC TESTS/Readily Carbonizable Substances Test <271>


Line 1 of Acceptance criteria: ChangeThe Sample may turn hazy, but it remains colorless, or shows a slight pink or yellow color, and the Sample does not become darker than the Standard solution.to:The oil portion of the Sample may turn hazy, but it remains colorless or shows a slight pink or yellow color, and the acid portion of the Sample does not become darker than the Standard solution.

ASSAY/Magnesium Oxide USP41-NF36

Line 5 of Analysis: Changeeriochrome black TStrituration to:eriochrome black Ttrituration

SPECIFIC TESTS/Viscosity/Acceptance criteria USP41-NF36

Line 1 of Type IA: Change225-600 to:225-600mPa · sANDLine 1 of Type IB: Change150-450 to:150-450 mPa · sANDLine 1 of Type IC: Change800-2200 to:800-2200 mPa · sANDLine 1 of Type IIA: Change100-300 to:100-300 mPa · s

ASSAY/Procedure

USP 40-NF 35 (Print) USP 39-NF 34 1S (Online) Line 1 of Acceptance criteria: Delete on the dried basis

IMPURITIES/Arsenic, Method I <211>


Line 1: Change3 µg/g to:NMT 3 µg/g


Line 1 of Standard solution: ChangePrepare 1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.to:1.0 mg/mL of USP Myristyl Alcohol RS in Internal standard solutionANDLine 1 of Sample solution: ChangePrepare 1.0 mg/mL of Myristyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until myristyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.to:1.0 mg/mL of Myristyl Alcohol in Internal standard solution


Line 1 of Standard solution: ChangePrepare 1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.to:1.0 mg/mL of USP Oleyl Alcohol RS in Internal standard solutionANDLine 1 of Sample solution: ChangePrepare 1.0 mg/mL of Oleyl Alcohol in Internal standard solution, and heat the solution in a sealed container in a 50° water bath until oleyl alcohol is dissolved. Allow the solution to cool to room temperature, and mix well.to: 1.0 mg/mL of Oleyl Alcohol in Internal standard solution

EXC1 Hong Wang Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

POLYETHYLENE GLYCOL 3350 EXC1 Hong Wang Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Sodium Stearyl Fumarate EXC1 Galina Holloway Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

Sorbitol Solution EXC1 Galina Holloway Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

DEXTROSE IDENTIFICATION/C. Water Determination <921> EXC2 Kevin Moore Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Sodium Cetostearyl Sulfate EXC2 Galina Holloway Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Sodium Chloride EXC2 Jenny Liu Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

EXC2 Jenny Liu Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

SUCROSE EXC2 Jenny Liu Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

Methacrylic Acid And Ethyl Acrylate Copolymer DEFINITION EXC2010 Hong Wang Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Methacrylic Acid And Ethyl Acrylate Copolymer EXC2010 Hong Wang Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Methacrylic Acid And Methyl Methacrylate Copolymer EXC2010 Hong Wang Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Methacrylic Acid And Methyl Methacrylate Copolymer DEFINITION EXC2010 Hong Wang Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Purified Stearic Acid EXC2010 Galina Holloway Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Stearic Acid EXC2010 Kevin Moore Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

<1024> Bovine Serum APPENDIX 1 GCBA Rebecca Potts Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

<1125> NUCLEIC ACID-BASED TECHNIQUES?GENERAL GCBA Dibyendu Saha Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

POLYETHYLEN E GLYCOL3350 SPECIFIC TESTS/Appa rent Weight- Average Molecular Weight and Polydispersit y USP41-NF36

Line 1 of Standard solution: ChangeStandard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solutionto:Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks. Pass a portion of each solution ANDLine 1 of Analysis/Samples: Change Standard solution and Sample solution to:Standard solutions and Sample solutionANDLine 3 of Analysis: ChangeSeparately inject equal volumes of the Standard solutionto:Separately inject equal volumes of the Standard solutions

SPECIFIC TESTS/Apparent Weight-Average Molecular Weight and Polydispersity

Line 1 of Standard solution: ChangeStandard solution: 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase. Pass a portion of the solutionto:Standard solutions: Prepare 1.0 mg/mL each of five polyethylene glycol standards with molecular weights of 1000,2000, 3000, 4000, and 6000 g/mol (Da) in Mobilephase separately in five individual flasks. Pass a portion of each solutionANDLine 1 of Analysis/Samples: ChangeStandard solution and Sample solutionto:Standard solutions and Sample solutionANDLine 3 of Analysis: ChangeSeparately inject equal volumes of the Standard solutionto:Separately inject equal volumes of the Standard solutions

SPECIFIC TESTS/Fats and Oils, Saponification Value <401>


Line 6 of Analysis: ChangeRinse the condenser with two 10-mL portions of 70% alcohol, add phenolphthalein TS,to:Rinse the condenser with 10 mL of 70% alcohol, followed by three 10-mL portions of water, collecting the rinsings in the flask. Cool, rinse the sides of the flask with two 10-mL portions of 70% alcohol, add phenolphthalein TS,

ASSAY/Procedure/Analysis USP41-NF36

In the variable definition list: ChangeCU = nominal concentration of Sorbitol Solution in the Sample solution (mg/g)to:CU = concentration of Sorbitol Solution in the Sample solution (mg/g)


Line 1: ChangeWater Determination <921>to:Water Determination <921>,Method I

IMPURITIES/Limit of Sodium Chloride and Sodium Sulfate/Sodium sulfate/Titrimetric systemUSP 40-NF 35 (Online & Print)

Line 1 of Endpoint detection: ChangePotentiometric to:Visual

IMPURITIES/Limit ofPotassium/Instrumental conditions

Line 1 of Mode: Change Atomic absorption spectrophotometryto:Atomic emission spectroscopy

SUCROSE SPECIFIC TESTS/Color Value/Analy sis USP41-NF36

Line 6 of the variable definition list: ChangeThe absolute difference between two results is NMT 3. to:Suitability requirementsRepeatability: The absolute difference between two results is NMT 3.

SPECIFIC TESTS/Color Value/Analysis

Line 6 of the variable definition list: ChangeThe absolute difference between two results is NMT 3. to:Suitability requirementsRepeatability: The absolute difference between two results is NMT 3.


Line 4: ChangeMethacrylic acid units in Methacrylic Acid and Ethyl Acrylate Copolymer are NLT 46.0% and NMT 50.6%, calculated on the dried basis.to:Methacrylic acid units in Methacrylic Acid and Ethyl AcrylateCopolymer, previously dried, are NLT 46.0% and NMT 50.6%.

IMPURITIES/Limit of Methacrylic Acid and Ethyl AcrylateUSP 40-NF 35 (Online & Print)

Line 5 of Standard solution: ChangeMix 10.0 mL of this solution to:Mix 5.0 mL of this solutionANDLine 7 of Standard solution: Change about 0.67 µg/mLto:about 0.5 µg/mLLine 4 of Sample solution: Change10.0 mL of this solution to:5.0 mL of this solutionANDIn the variable definition list in Analysis: ChangeVF = final volume of the Sample solution, 15 mLD = dilution factor for preparation of the Sample solution, 5to:VF = final volume of the Sample solution, 10 mLD = dilution factor for preparation of the Sample solution, 10

ASSAY/Procedure


Line 3 of Acceptance criteria: Delete on the dried basisANDLine 5 of Acceptance criteria: Delete on the dried basis


Methacrylic acid units in Methacrylic Acid and Methyl Methacrylate Copolymer are NLT 27.6% and NMT 50.6%, calculated on the dried basis.to:Methacrylic acid units in Methacrylic Acid and Methyl MethacrylateCopolymer, previously dried, are NLT 27.6% and NMT 50.6%.



Line 2 of Relative standard deviation: Change six replicate injections of Sample solution;to:six replicate injections;



Line 3 of Relative standard deviation: Changepeaks (from six replicate injections of Sample solution);to:peaks, from six replicate injections;


Line 2 of bullet 1 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf to:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_g uideline/2009/09/WC500003684.pdfANDLine 2 of bullet 2 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/human/bwp/179302en.pdf to:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_g uideline/2009/WC500003675.pdfANDLine 3 of bullet 3 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/vet/iwp/074300en.pdfto: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_g uideline/2009/10/WC500004575.pdfANDDelete bullet 4 of International Regulations and Guidance Documents in second paragraphANDLine 2 of bullet 5 of International Regulations and Guidance Documents in second paragraph: Change http://www.emea.europa.eu/pdfs/human/bwp/TSE%20NFG%20410- rev2.pdfto: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_g uideline/2009/09/WC500003712.pdfANDLine 1 of bullet 6 of International Regulations and GuidanceDocuments in second paragraph: Change Terrestrial animal health code 2007. Available at http://www.oie.int/eng/normes/mcode/code2007/anc- en_summary.htm.to:Terrestrial animal health code. Available at http://www.oie.int/doc/ged/D10905.pdf.

APPENDICES/Appendix 1: Regulations and StandardsLine 1 of bullet 1: Change "Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms" (1993) to: "Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens" (2005)

GCBA Dale Schmidt Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

GCBA Krishna Menon Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

GCBA Fouad Atouf Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

<212> OLIGOSACCHARIDE ANALYSIS SEPARATION AND IDENTIFICATION OF OLIGOSACCHARIDES GCBA Fouad Atouf Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

INTRODUCTION GCBA2010 Kamalpreet Arora Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

<1058> Analytical Instrument Qualification GCCA Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

<1224> Transfer Of Analytical Procedures GCCA Horacio Pappa Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

<191> Identification Tests—General GCCA Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

<191> Identification Tests—General GCCA Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

<852> Atomic Absorption Spectroscopy GCCA Edmond Biba Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

GCDF Desmond Hunt Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 1/1/2016

GCDF K. Seela Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

<1724> Semisolid Drug Products—Performance Tests IN VITRO PERFORMANCE GCDF Margareth Marques Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

<4> Mucosal Drug Products—Product Quality Tests GCDF William Brown Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

C. AERODYNAMIC SIZE DISTRIBUTION— INHALATION AEROSOLS, SPRAYS, AND POWDERS GCDF Kahkashan Zaidi Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

GCDF Kahkashan Zaidi Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017

<603> TOPICAL AEROSOLS DELIVERED-DOSE UNIFORMITY GCDF Kahkashan Zaidi Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

<711> Dissolution GCDF Margareth Marques Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

<1125> NUCLEIC ACID-BASEDTECHNIQUES? GENERAL

APPENDICE S/Appendix1: Regulations and Standards USP41-NF36

Line 1 of bullet 1: Change"Review Criteria for Nucleic Acid Amplification-Based In Vitro Diagnostic Devices forDirect Detection of Infectious Microorganisms" (1993)to:"Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens" (2005)

<1132> Residual Host Cell Protein Measurement in Biopharmaceuticals 4. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4


Product column: Change10.00 (neat), 5.00, 2.50, 1.25, 0.63, 0.31, 0.16 to:10.00 (neat), 5.00, 2.50, 1.25, 0.625, 0.3125, 0.15625ANDSample 1/HCP ratio column: Change4.9, 5.7, 4.8, 5.9, 5.0, 5.1, <6 to:4.90, 5.70, 4.80, 5.92, 4.96, 5.12, <6ANDSample 2/HCP ratio column: Change2.0, 3.3, 4.0, 5.9, 5.3, 6.1, <6 to:2.00, 3.30, 4.00, 5.92, 5.28, 6.08, <6ANDSample 3/HCP ratio column: Change0.3, 0.5, 0.6, 0.9, 1.4, <6, <6 to:0.32, 0.50, 0.60, 0.88, 1.44, <6, <6ANDSample 3/% max ratio value column: Change83%to:61%

<212> OLIGOSACCHA RIDEANALYSIS SEPARATIO N AND IDENTIFICA TION OF OLIGOSACC HARIDES USP41-NF36

Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: ChangeAdd 1.4 M ammonia solution to 1.4 M formic acid solution. to:Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained.

Line 1 of Normal Phase Chromatography/HILIC/Ammonium formate buffer: Change: Add 1.4 M ammonia solution to 1.4 M formic acid solution to: Add 1.4 M ammonia solution to 1.4 M formic acid solution until a pH of 4.4 is obtained.

<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis


A paragraph before the Introduction was deleted:This chapter provides guidance and procedures used for characterization of biotechnology-derived articles by polyacrylamide gel electrophoresis. Portions of the chapter that are not harmonized with the other two pharmacopeias are marked by the symbol . This chapter ♦is harmonized with the corresponding chapter in JP and EP. Other characterization tests, also harmonized, are shown in Biotechnology-Derived Articles—Amino Acid Analysis <1052>, Biotechnology-Derived Articles—Capillary Electrophoresis <1053>, Biotechnology-Derived Articles—Isoelectric Focusing <1054>, Biotechnology-Derived Articles—Peptide Mapping <1055>, and Biotechnology-Derived Articles—Total Protein Assay <1057>.

ANALYTICAL INSTRUMENT QUALIFICATION PROCESS/Qualification PhasesAntonio Hernandez-Cardoso

Line 2 of paragraph 1 of Operational Qualification: ChangeOQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.to:OQ demonstrates fitness for the selected use, and should reflect URS.ANDLine 2 of paragraph 3 of Operational Qualification/Instrument Function Tests: Change Holistic tests, which involve the entire system, demonstrate that the whole system complies with user specifications in the DQ.to:Holistic tests, which involve the entire system, demonstrate that the whole system complies with URS.

TYPES OF TRANSFERS OF ANALYTICAL PROCEDURES

Line 12 of Transfer Waiver: ChangeIf eligible for transfer waiver, the receiving receiving unit to:If eligible for transfer waiver, the receiving unit

INSTRUMENTAL IDENTIFICATION TESTSAntonio Hernandez-Cardoso

Line 5 of paragraph 1: Changetechiques to: techniques

CHEMICAL IDENTIFICATION TESTS/AcetateAntonio Hernandez-Cardoso

Line 3 of A.: Change0.1 mL of iodine, and potassium iodide TS 3, to:0.1 mL of iodine and potassium iodide TS 3,

VALIDATION AND VERIFICATION/Precision/ Intermediate Precision


Line 3: ChangeAs a minimum, the analytical procedure should be assessed by performing the repeatability test in any of the conditions previously mentioned (totaling 12 measurements).to:As a minimum, the analytical procedure should be assessed by performing the repeatability test in any combination of at least two of the conditions previously mentioned (totaling 12 measurements).

<1> Injections And Implanted Drug Products (Parenterals)—Product Quality Tests INTRODUCTION

USP41-NF36 (Print) USP40 NF35 2S (Online)

Line 3 of paragraph 3: Changeparental to: parenteral

<1602> Spacers and Valved Holding Chambers used with Inhalation Aerosols Characterization Tests

1. INTRODUCTION/1.5Definitions of Key TermsRelating to This Chapter USP41-NF36

Bottom right corner of Figure 1:Change VHC mouthpieceto:Spacer mouthpiece

USP 40-NF 35 (Online & Print) Line 7 of Application of Drug Release: Change

PRODUCT QUALITY TESTS FOR MUCOSAL DRUG PRODUCTS/General Necessary Tests/Impurities


Line 1 of footnote 2: Change http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guideline s/Quality/Q3B_R2/Step4/Q3B_R2_Guideline.pdf.to: http://www.ich.org/products/guidelines/quality/article/quality- guidelines.html.

<601> Inhalation and Nasal Drug Products—Aerosols, Sprays, and Powders—Performance Quality Tests


Line 13 of paragraph 2 of C.3 Apparatus 2 for Inhalation Powders— Marple Miller Impactor/C.3.1 Design—Apparatus 2: ChangeAdjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration of T seconds as determined during testing for Delivered-Dose Uniformity.to:Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.ANDLine 3 of paragraph 2 of C.4 Apparatus 3 for Inhalation Powders— Andersen Impactor (with pre-separator)/C.4.1 Design—Apparatus 3: ChangeOnce the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration, T ± 5%, as determined during testing for Delivered-Dose Uniformity.to:Once the product is positioned, discharge the powder into the apparatus by activating the timer and opening the two-way solenoid valve for the required duration such that the total volume sampled is at least 4 L.ANDLine 19 of paragraph 2 of C.5 Apparatus 4 for Inhalation Powders— Multistage Liquid Impinger/C.5.1 Design—Apparatus 4: Change Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.to:Adjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the duration such that the total volume sampled is at least 4 L.ANDLine 9 of paragraph 4 of C.6 Apparatus 5 for Inhalation Powders—NextGeneration Impactor (with pre-separator)/C.6.2 Procedure—Apparatus5: ChangeAdjust the timer controlling the operation of the two-way solenoid valve so that it opens the valve for the same duration, T, as used during testing for Delivered-Dose Uniformity.to:Adjust the timer controlling the operation of the two-way solenoid valve so that it opens this valve for a duration such that the total volume sampled is at least 4 L.

<603> TOPICAL AEROSOLS DELIVERED- DOSE UNIFORMITY USP41-NF36

Line 2: Changeproceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>,to:proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, andPowders?Performance Quality Tests <601>, A. Delivered-Dose Uniformity/A.2Inhalation Aerosols and Inhalation Sprays and A.4 Inhalation Powders, ANDLine 4: DeleteUnless otherwise stated in the individual monograph, apply the acceptance criteria forMetered-Dose Inhalers and Dry Powder Inhalers as described in <601>.

Line 2: Change: proceed as directed in the test for Delivered Dose Uniformity in Metered-Dose Inhalers and Dry Powder Inhalers, as described in <601>, to: proceed as directed in Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders?Performance Quality Tests <601>, A. Delivered-Dose Uniformity/A.2 Inhalation Aerosols and Inhalation Sprays and A.4 Inhalation Powders ,AND Line 4: Delete Unless otherwise stated in the individual monograph, apply the acceptance criteria for Metered-Dose Inhalers and Dry Powder Inhalersas described in <601>.

INTERPRETATION/Immediate-Release Dosage Forms/Immediate- Release Dosage Forms Pooled Sample


Row 3 of Column 1 of Acceptance Table for a Pooled Sample: ChangeS1 to: S2ANDRow 4 of Column 1 of Acceptance Table for a Pooled Sample: ChangeS1to:S3

GCM Radhakrishna Tirumalai Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

<81> Antibiotics—Microbial Assays GCM Morgan Puderbaugh Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

<1664.1> Orally Inhaled and Nasal Drug Products REFERENCES GCPD Desmond Hunt Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 Delete reference 3. 9/1/2016

REFERENCES GCPD Desmond Hunt Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 Delete reference 8. 9/1/2016

<659> Packaging and Storage Requirements GENERAL DEFINITIONS GCPD Desmond Hunt Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

<661.1> Plastic Materials Of Construction GCPD Desmond Hunt Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016





<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS GCPD Desmond Hunt Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

TEST METHODS/Physicochemical Tests/Water Extraction/Acidity or alkalinity GCPD Desmond Hunt Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

<670> AUXILIARY PACKAGING COMPONENTS DESICCANTS/Silica Gel/Inorganic Impurities GCPD Desmond Hunt Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

<671> Containers—Performance Testing GCPD Desmond Hunt Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

REFERENCES GCPD Desmond Hunt Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 Delete references 5, 7, 9, and 12. 9/1/2016

Description and Solubility SUNFLOWER OIL HDQ Sujatha Ramakrishna Errata Errata n/a n/a 11/20/2015 11/20/2015 12/1/2015 7/1/2016

Description And Solubility HDQ Sujatha Ramakrishna Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Reagents HDQ Margareth Marques Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

Reagents, Indicators And Solutions HDQ Margareth Marques Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Reagents, Indicators And Solutions HDQ Margareth Marques Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

<1207> STERILE PRODUCT PACKAGING−INTEGRITY EVALUATION

5. PRODUCT–PACKAGE QUALITY REQUIREMENTS AND THE MAXIMUM ALLOWABLE LEAKAGE LIMIT/5.1 Sterility and Product Formulation Content must be Preserved; Gas Headspace Content Preservation is not Required


Line 3 of paragraph 5: Changeultra-cold storage (<80°)to:ultra-cold storage (≤−80°) Line 3 of paragraph 5: Changeultra-cold storage (<80°)to:ultra-cold storage (≤−80°)

APPENDIX 1. FORMULAS FOR MANUAL CALCULATIONS OF REGRESSION AND SAMPLE CONCENTRATION


Line 19: Changeb = [(4 × 17.222) + (2 × 16.511) - (2 × 14.989) - (4 ×14.020)]/{5[ln(7.81)] - ln(3.2)} = 3.551 to:b = [(4 × 17.222) + (2 × 16.511) - (2 × 14.989) - (4 ×14.020)]/{5[ln(7.81) - ln(3.2)]} = 3.551


<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems



Line 1 of Single-Dose (see also Injections <1>, Containers forInjections): ChangeA single-unit package for an article intended for parenteral administration. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.to:A single-unit package for an article intended for parenteral administration. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion- sealed containers, and closure-sealed containers when so labeled.

SPECIFICATIONS/Polyethylene Terephthalate and Polyethylene Terephthalate G/Extractable MetalsUSP 40-NF 35 (Online & Print)

Line 1 of Titanium: Change0.1 µg/g. to:1 µg/g.

SPECIFICATIONS/Polyethylene/Extractable MetalsUSP 40-NF 35 (Online & Print)

Line 1 of Zirconium: Change1 µg/g. to:0.1 µg/g.

TEST METHODS/Extractions/Table 3USP 40-NF 35 (Online & Print)

Column 4 of S3 row: ChangeExtractable metals: Al, Sb, As, Ba, Cd, Co, Ge, Hg, Mn, Ni, Pb, Ti, V, and Znto:Extractable metals: Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V, and Zn

TEST METHODS/Extractions/Table 3USP 40-NF 35 (Online & Print)

Line 1 of footnote b: ChangeFor nonplasticized polyethylene only. to:For polyethylene only.

TEST METHODS/Physicochemical Tests/AbsorbanceUSP 40-NF 35 (Online & Print)

Line 3 of Plasticized polyvinyl chloride: DeleteAdditionally, for nonplasticized polyvinyl chloride materials only, determine the spectrum between 250 and 330 nm in the alcohol sample associated with Solution S6.


Line 1 of Physicochemical Tests/Acidity or Alkalinity/BRP indicator solution: Change1.0 mg/mL of bromophenol blue,to:1.0 mg/mL of bromothymol blue,ANDLine 3 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test B: Changetris(2,4-di-tert-butylphenyl) phosphate;to:tris(2,4-di-tert-butylphenyl) phosphite;ANDLine 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Phenolic Antioxidants/Test C/Mobile phase: Change(55:45:5, v/v/v)to:(50:45:5, v/v/v)ANDLine 1 of Plastic Additives/Polyethylene, Cyclic Olefins, and Polypropylene/Nonphenolic Antioxidants/Chromatographic system/Application: Change20 µL of Sample solution S10, reference solution (o) and the reference solutions corresponding toto:20 µL of Sample solution S10 and the reference solutions corresponding toANDLine 2 of Plastic Additives/Plasticized Polyvinyl Chloride/USP Reference Standards <11>/USP Plastic Additive 05 RS: ChangeTris(2,4-di-tert-butylphenyl) phosphate.to:Tris(2,4-di-tert-butylphenyl) phosphite.

<661.2> PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE


Line 2 of Methyl red TS 2: ChangeNMT 0.1 mL of 0.02 N hydrochloric acidto:NMT 0.1 mL of 0.02 N sodium hydroxide


Line 1 of Soluble ionizable salts: Change(as NaSO3):to:(as Na2SO4):

MOISTURE VAPOR TRANSMISSION/Packaging System Classification for Multiple-Unit Containers and Unit- Dose Containers for Liquid Oral Dosage Forms/Procedure


Line 1 of the Equation: Change[(W1i - WT) - (W14i - WT) - (WC1 - WC14)] × 365 × {[100/(W1i - WT)] ×14}to:[(W1i - WT) - (W14i - WT) - (WC1 - WC14)] × 365 × 100/(W1i - WT) × 14

<1663> Extractables Associated With Pharmaceutical Packaging Systems



Line 5: ChangeNF category: Coating agent; emollient; solvent; tablet and/or capsule diluent; vehicle (oleaginous).to:NF category: Coating agent; emollient; solvent; diluent; vehicle(oleaginous).

PALIPERIDONE

Line 1: ChangeSparingly soluble in 0.1 N hydrochloride and in methylene chloride; slightly soluble in N,N-dimethylformamide and in terahydrofuran;to:Sparingly soluble in 0.1 N hydrochloric acid and in methylene chloride; slightly soluble in N,N- dimethylformamide and in tetrahydrofuran;

REAGENT SPECIFICATIONS/Bromelain/Activi ty Determination


Line 1 of Buffer solution: Change Add 150 mg of sodium chloride to:Add 150 g of sodium chloride

REAGENTS/6. General Tests for Reagents/6.2 Amino Nitrogen Test in ReagentsUSP 40-NF 35 (Online & Print)

In the numerator of the equation: Change2.8 to:14AND Add× fANDLine 10: Changewhere %LOD is the percentage of loss on drying. to:where f is the correction factor obtained in the standardization of 0.2 Nsodium hydroxide and %LOD is the percentage of loss on drying.

Solutions/Volumetric Solutions USP41-NF36

Line 3 of 0.07 N Ferrous Ammonium Sulfate VS: Change In a 100-mL volumetric flask,to:In a 1000-mLvolumetric flask,

Reagents, Indicators And Solutions HDQ Margareth Marques Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

<481> Riboflavin Assay NBDS Huy Dinh Errata Errata n/a n/a 3/31/2017 3/31/2017 4/1/2017 5/1/2017

Adenine NBDS Huy Dinh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Arginine Hydrochloride NBDS Huy Dinh Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Calcium L-5- Methyltetrahydrofolate NBDS Huy Dinh Errata Errata n/a n/a 1/27/2017 1/27/2017 2/1/2017 USP41-NF36 1/1/2016

Calcium Lactate Tablets NBDS Natalia Davydova Errata Errata n/a n/a 9/25/2015 9/25/2015 10/1/2015 7/1/2016

CHONDROITIN SULFATE SODIUM IMPURITIES NBDS Huy Dinh Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Chondroitin Sulfate Sodium, Shark NBDS Huy Dinh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016



Glucosamine Sulfate Potassium Chloride CHEMICAL INFORMATION NBDS Huy Dinh Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

Glucosamine Sulfate Sodium Chloride CHEMICAL INFORMATION NBDS Huy Dinh Errata Errata n/a n/a 1/29/2016 1/29/2016 2/1/2016 7/1/2016

NBDS Huy Dinh Errata Errata n/a n/a 5/26/2017 5/26/2017 6/1/2017 5/1/2017METHIONINE NBDS Huy Dinh Errata Errata n/a n/a 7/28/2017 11/1/2017 5/1/2018 USP41-NF36 8/1/2017

OMEGA-3-ACID ETHYL ESTERS CAPSULES ASSAY/Content of EPAee, DHAee, and Total Omega-3-Acid Ethyl Esters NBDS Natalia Davydova Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

OMEGA-3-ACID ETHYL ESTERS CAPSULES SPECIFIC TESTS/Concentration of Omega-3-Acid Ethyl Esters NBDS Natalia Davydova Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Omelena Gonikberga-3-Acid Ethyl Esters Capsules ASSAY/Content of EPAee, DHAee, and Total OmElena Gonikberga-3-Acid Ethyl Esters/Analysis NBDS Natalia Davydova Errata Errata n/a n/a 9/30/2016 9/20/2016 10/1/2016 9/1/2016<1790> Visual Inspection of Injections GCDF Desmond Hunt Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

<1790> Visual Inspection of Injections GCDF Desmond Hunt Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

<191> Identification Tests—General GCCA Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

<800> Hazardous Drugs—Handling In Healthcare Settings CMP Jeanne Sun Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

<800> Hazardous Drugs—Handling In Healthcare Settings CMP Jeanne Sun Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Almotriptan Malate CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Almotriptan Tablets CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Calcium Stearate EXC1 Galina Holloway Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Chloroquine Phosphate CHM1 Shankari Shivaprasad Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Chlorpheniramine Maleate CHM6 Richard Nguyen Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Cilostazol CHM2 Edith Chang Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

SOLUTIONS/Volumetric Solutions/1 N Sulfuric Acid VS


Line 3 of Standardization: Change dried at 150°to:dried at 105°

ASSAY USP41-NF36

Line 2 of the variable definition list in Chemical Methods, Procedure1/Analysis: Change sodium hydrofluorite to:sodium hydrosulfite

CHEMICAL INFORMATION

Line 2: Change1H-Purin-6-amine;to:9H-Purin-6-amine;

SPECIFIC TESTS/Chloride ContentUSP 40-NF 35 (Online & Print)

Delete the subsectionBlank: 140 mL of water and 1 mL of dichlorofluorescein TS ANDThe equation in the Analysis: Change Result = [(V - B) × N × F × 100]/W to:Result = (V × N × F × 100)/WANDLine 10 of Analysis: DeleteB = Blank titrant volume (mL)

IMPURITIES/EnantiomericPurity/Chromatographic system

Line 1 of Column: Change packing L791to:packing L79ANDDelete footnote 1

ASSAY/Procedure


Line 3 of Analysis: ChangeWhile stirring, add 30 mL of Titrant from a 50-mL buret. to:While stirring, add 15 mL of Titrant from a 50-mL buret.


Line 1 of Residue on Ignition <281>: Change20.0%–30.0% to:20.0%–30.0% on the dried basis

COMPOSITION/Disaccharide CompositionUSP 40-NF 35 (Online & Print)

Line 2 of Chondroitinase ABC solution: Change10.0 mL of Buffer solutionto:1.0 mL of Buffer solutionANDLine 4 of Analysis: Change and 1.0 mLto:and 0.1 mL

IMPURITIES/Limit of ProteinUSP 40-NF 35 (Online & Print)

Line 2 of Instrumental conditions: Change(See Spectrophotometry and Light-Scattering <851>.)to:(See Ultraviolet-Visible Spectroscopy <857>.)

SPECIFIC TESTS/Clarity and Color of SolutionUSP 40-NF 35 (Online & Print)

Line 2 of Instrumental conditions: Change(See Spectrophotometry and Light-Scattering <851>.)to:(See Ultraviolet-Visible Spectroscopy <857>.)


Line 5: Change [38899-05-7]. to:[1296149-08-0].


Line 5: Change [38899-05-7]. to:[1296149-13-7].

METHIONINE

IMPURITIES/RelatedCompounds USP41-NF36

Row 5 of Column 3 of Table 2: Change0.1 to:1.0

IMPURITIES/Related Compounds Row 5 of Column 3 of Table 2: Change 0.1 to 1


Line 21 of Analysis: ChangeCU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)to:CU = Capsule fill content of the Sample solution (g/mL)


Line 21: ChangeCU = nominal concentration of the total omega-3-acid ethyl esters in the Sample solution (g/mL)to:CU = Capsule fill content of the Sample solution (g/mL)


Line 16 of the third equation: ChangeL = label claim of total omElena Gonikberga-3-acids ethyl esters (g/Capsule)to:L = label claim of total omElena Gonikberga-3-acids ethyl esters (mg/Capsule)

2. BACKGROUND/2.2Patient Risk

USP 42-NF 37 (Print) USP41- NF36 2S (Online)

Line 6 of paragraph 3: Change109 particles/kg to:109 particles/kg

4. INSPECTION LIFE-CYCLE/4.2Prevention ofParticulates


Line 5 of paragraph 1 of Robust Design During Development: Changelamellae (46,47)to:lamellae as discussed in Evaluation of the Inner Surface Durability of Glass Containers <1660> and by the FDA (45)ANDLine 2 of paragraph 4 of Robust Design During Development: Change(ICH)-relevant trials. to:(ICH)-relevant trials (46).

CHEMICAL IDENTIFICATION TESTS/ThiosulfateAntonio Hernandez-Cardoso


Line 1 of A.: Changeyellow; with the addition of sulfur dioxide, filter paper moistened with mercurous nitrate TS blackens.to:yellow, and evolve sulfur dioxide, which blackens filter paper moistened with mercurous nitrate TS.

5. FACILITIES AND ENGINEERING CONTROLS/5.4Containment Supplemental Engineering Controls


Line 5 of paragraph 1: Change containment reduction.to:contamination reduction.

7. PERSONAL PROTECTIVE EQUIPMENT


Line 2 of paragraph 2: Change antineoplastic HDs.to:injectable antineoplastic HDs.

ADDITIONAL REQUIREMENTS/USP Reference Standards<11>


Line 2 of USP Almotriptan Related Compound D RS: Change1-[({3-[2-(Dimethylamino)ethyl]indol-5- yl}methyl)sulfonyl]pyrrolidine N-oxide. C17H25N3O3S 351.46to:1-[({3-[2-(Dimethylamino)ethyl]indol-5- yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride. C17H25N3O3S · HCl 387.92



Line 4 of USP Almotriptan Related Compound B RS: ChangeC15H22N3O2S to: C15H21N3O2S ANDLine 2 of USP Almotriptan Related Compound D RS: Change1-[({3-[2-(Dimethylamino)ethyl]indol-5- yl}methyl)sulfonyl]pyrrolidine N-oxide. C17H25N3O3S 351.46to:1-[({3-[2-(Dimethylamino)ethyl]indol-5- yl}methyl)sulfonyl]pyrrolidine N-oxide hydrochloride. C17H25N3O3S · HCl 387.92

IDENTIFICATION


Line 3 of B.: Change obtained in the Assay. to:obtained in the Assay for Content of Stearic Acid and PalmiticAcid.



Line 3 of Analysis: ChangeCalculate the percentage of each specified impurity to:Calculate the percentage of each specified impurity, other than chloroquine related compound G,ANDIn Analysis/second equation/variable definition list: Change rU=peak response of chloroquine N-oxide or any other impurity from the Sample solutionrU=peak response of chloroquine related compound G or any other impurity from the Sample solution



Line 2 of USP Chlorpheniramine Related Compound C RS: Change3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine. C15H17CIN2 260.76to:3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.C15H17CIN2 · C4H4O4 376.83

USP Reference standards <11>


Line 2 of USP Cilostazol Related Compound C RS: Change1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-1H- tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.C31H43N9O3 589.73 to:1-(4-(1-Cyclohexyl-1H-tetrazol-5-yl)butyl)-6-(4-(1-cyclohexyl-1H- tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one.C31H45N9O2 575.75

Dexchlorpheniramine Maleate CHM6 Sujatha Ramakrishna Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Divalproex Sodium Extended-Release Tablets CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Donepezil Hydrochloride CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018


Glutaral Concentrate CHM1 Shankari Shivaprasad Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Hydroxyzine Hydrochloride CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Hydroxyzine Hydrochloride Oral Solution CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Hydroxyzine Hydrochloride Tablets CHM4 Heather Joyce Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Irinotecan Hydrochloride CHM3 Feiwen Mao Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Mycophenolic Acid Delayed-Release Tablets CHM3 Feiwen Mao Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Mycophenolic Acid Delayed-Release Tablets CHM3 Feiwen Mao Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Pilocarpine Hydrochloride Ophthalmic Solution CHM3 Feiwen Mao Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Sodium Lauryl Sulfate EXC2 Jenny Liu Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Verapamil Hydrochloride Extended-Release Tablets CHM2 Donald Min Errata Revision n/a n/a 11/17/2017 11/17/2017 12/1/2017 1/1/2018

Potassium Citrate Extended-Release Tablets NBDS Natalia Davydova Errata Revision n/a n/a 9/29/2017 9/29/2017 10/1/2017 9/1/2017

RIBOFLAVIN 5 -PHOSPHATE SODIUM′ ASSAY/Procedure NBDS Huy Dinh Errata Errata n/a n/a 11/18/2016 11/18/2016 12/1/2016 11/30/2016

Selenomethionine CHEMICAL INFORMATION NBDS Huy Dinh Errata Errata n/a n/a 3/25/2016 3/25/2016 4/1/2016 7/1/2016

Vinpocetine NBDS Huy Dinh Errata Errata n/a n/a 5/27/2016 5/27/2016 6/1/2016 7/1/2016

Amoxicillin Tablets for Oral Suspension SM12010 Morgan Puderbaugh Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Doxazosin Mesylate SM22010 Sujatha Ramakrishna Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016



Line 2 of USP Chlorpheniramine Related Compound C RS: Change3-(4-Chlorophenyl-N-methyl-3-(pyridin-2-yl)propan-1-amine. C15H17CIN2 260.76to:3-(4-Chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1-amine maleate.C15H17CIN2 · C4H4O4 376.83

ASSAY/Procedure


Line 2of Mobile phase: ChangeAdjust with phosphoric acid to a pH of 5.0. to:Adjust with diluted sodium hydroxide or phosphoric acid to a pH of5.0.

IMPURITIES/OrganicImpurities, Procedure 2


Footnote b of Table 3: Change(E)-4-[(5,6-Dimethoxy-1-oxo-1H-inden-2-yl)methyl]pyridine 1- oxide.to:(E)-4-[(5,6-Dimethoxy-1-oxo-1,3-dihydro-2H-inden-2- ylidene)methyl]pyridine 1-oxide.

ASSAY/Procedure


Line 2of Solution A: Change1 g/Lto:1.1 g/L

ASSAY/Procedure


Line 7 of Analysis: ChangeAdd a weighed quantity of Concentrate containing 1.2 g of glutaral by means of a suitable weighing pipet.to:Add 1.2 g of Glutaral Concentrate.

ASSAY/Procedure


Line 2 of Solution B: Change(0.5: 99.5)to:(0.05: 99.95)

ASSAY/Procedure


Line 2 of Solution B: Change(0.5: 99.5)to:(0.05: 99.95)

ASSAY/Procedure


Line 2of Solution B: Change(0.5: 99.5)to:(0.05: 99.95)



Line 2 of USP Irinotecan Related Compound C RS: Change(S)-9-[(1,4'-Bipiperidine)-1'-carbonyloxy]-4-methyl-11-ethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H- pyrano[3',4':6,7]indolizino[1,2-b]quinoline hydrochloride. to:11-Ethyl-4-hydroxy-4-methyl-3,14-dioxo-3,4,12,14-tetrahydro-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl (1,4'- bipiperidine)-1'-carboxylate hydrochloride.



In Acid stage/Analysis/variable definition list: ChangeV = volume of Medium, 750 mLto:V = volume of Acid stage medium, 750 mL ANDIn Buffer stage/Analysis/variable definition list: ChangeV = volume of Medium, 1000 mLto:V = volume of Buffer stage medium, 1000 mL



ChangeMobile phase, Standard solution, Sample solution, andChromatographic system:to:Mobile phase, Diluent, Standard solution, Sample solution, andChromatographic system:

ASSAY/Procedure


Line 2 of Standard solution: Change waterto:methanol

IDENTIFICATION


Line 1 of A.: ChangeInfrared Absorption <197K> or <197A>to:?A. Infrared Absorption <197K> or <197A>?



Row 5 of column 2 of Table 9: Change4 to:5

ASSAY/Procedure


Line 1 of Chromatographic system/Column: Change10-µm to:5-µmANDIn the variable definition list in Analysis: ChangerU = citrate peak area from the Sample solutionrS = citrate peak area from the Standard solutionto:rU = citric acid peak area from the Sample solutionrS = citric acid peak area from the Standard solutionANDChangeMr2 = molecular weight of citrate (C6H5O7), 189.10 to:Mr2 = molecular weight of citric acid (C6H8O7), 192.13


Line 2 of Instrumental conditions: ChangeNephelometry, Turbidimetry, and Visual Comparison <855>to:Fluorescence Spectroscopy <853>


Line 3: Change[1464-42-2]to:[3211-76-5]


Footnote a of Table 1: ChangeEthyl (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (ethyl vincaminate). to:Ethyl (12S,13aS,13bS)-13a-ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b- octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (ethyl vincaminate).ANDFootnoteb of Table 1: ChangeMethyl (13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b- hexahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (apovincamine).to:Methyl (13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H- indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (apovincamine).ANDFootnote d of Table 1: ChangeEthyl (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b- octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (dihydrovinpocetine).to:Ethyl (12R,13aS,13bS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate(dihydrovinpocetine).

ASSAY/Procedure


Line 6 of Analysis: ChangeResult = (rU/rS) × (CS/CU) × P × (1/F) ×100 to:Result = (rU/rS) × (CS/CU) × P × F × 100

IMPURITIES/Organic Impurities/Analysis


Line 3 of the variable definition list: ChangerS = peak response of each impurity from the Standard solutionto:rS= peak response of each impurity or doxazosin mesylate (for calculating unspecified impurities) from the Standard solution ANDLine 5 of the variable definition list: ChangeCS = concentration of USP Doxazosin Mesylate RS in the Standard solution (mg/mL)to:CS= concentration of the corresponding USP Doxazosin Related Compound RS or USP Doxazosin Mesylate RS (for calculating unspecified impurities) in the Standard solution (mg/mL)

Metolazone Tablets SM22010 Donald Min Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Oxaprozin Tablets SM22010 Hillary Cai Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Methotrexate SM32010 Feiwen Mao Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Almotriptan Malate SM42010 Heather Joyce Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Estradiol and Norethindrone Acetate Tablets SM42010 Galina Holloway Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Tetracaine Hydrochloride For Injection Chromatographic purity SM42010 Ren-Hwa Yeh Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Tetracaine Hydrochloride For Injection Identification SM42010 Ren-Hwa Yeh Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Tetracaine Hydrochloride In Dextrose Injection Identification SM42010 Ren-Hwa Yeh Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

Tetracaine Hydrochloride Injection Identification SM42010 Ren-Hwa Yeh Errata Errata n/a n/a 7/31/2015 7/31/2015 8/1/2015 7/1/2016

GCBA Kamalpreet Arora Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018




BDSHM Anton Bzhelyansky Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018




BDSHM Natalia Davydova Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018



CHM4 Heather Joyce Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

CHM4 Heather Joyce Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

HDQ Margareth Marques Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

CHM5 Gerald Hsu Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

ASSAY/Procedure


Change the subsectionStandard solution: 5 µg/mL of USP Metolazone RS in methanol to: Standard stock solution: 0.25 mg/mL of USP Metolazone RS in methanolStandard solution: 5 µg/mL of USP Metolazone RS in Mobile phasefrom Standard stock solutionANDLine 2 of Sample solution: Changeof metolazone from the Sample stock solution in methanol to:of metolazone in Mobile phase from the Sample stock solution

IMPURITIES/Organic Impurities/System suitability/Suitability requirements


Delete the subsectionSignal-to-noise ratio: NLT 3000

IMPURITIES/Organic Impurities/Procedure 1: Related Compounds


Line 15 of Analysis: Changemethotrexate related compound E free acid to:methotrexate related compound E free baseANDLine 8 of the second variable definition list for Analysis: Change methotrexate related compound E free acidto:methotrexate related compound E free baseANDRow 5 of Column 1 of Impurity Table 1: ChangeMethotrexate related compound E free acidcto:Methotrexate related compound E free basec

IMPURITIES/Limit of Almotriptan Related Compound D and Almotriptan N-Dimer


Line 1of Internal standard solution: Change4-hydroxy-phenylpiperidine to:4-hydroxy-4-phenylpiperidine

IMPURITIES/Organic Impurities/Procedure/System suitability


Line 2 of the Note: Change1.0, 1.4, and 3.0, to:1.0, 1.1, and 1.7,


Line 1: ChangeDissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL, and proceed as directed in the test for Chromatographic purity under Tetracaine, beginning with “Prepare a Standard solution.”to:Dissolve an accurately weighed quantity of Tetracaine Hydrochloride for Injection in water to obtain a test solution containing 50 mg per mL. Prepare a Standard solution of 4-(butylamino) benzoic acid in methanol containing 0.2 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a0.25-mm layer of chromatographic silica gel mixture. Develop the plate in a suitable chromatographic chamber containing a solvent system consisting of a mixture of chloroform, methanol, and isopropylamine (98:7:2) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry in a current of warm air. Examine the plate under short-wavelength UV light: any spot obtained from the test solution, other than the principal spot, is not more intense than the principal spot obtained from the Standard solution (0.4%), and the sum of the intensities of any such spots is not greater than 0.8%.


Line 1 of B: ChangeIt responds to Identification test B under Tetracaine Hydrochloride. to:Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.


Line 1 of B: ChangeIt responds to Identification test C under Tetracaine Hydrochloride. to:A solution of 100 mg in 5 mL of water meets the requirements of the tests for Chloride <191>.


Line 1 of A: ChangeIt responds to Identification test B under Tetracaine Hydrochloride. to:Dissolve 100 mg in 10 mL of water, and add 1 mL of potassium thiocyanate solution (1 in 4): a crystalline precipitate is formed. Recrystallize the precipitate from water, and dry at 80° for 2 hours: it melts between 130° and 132°.

<1103> IMMUNOLOGICAL TEST METHODS—ENZYME- LINKEDIMMUNOSORBENT ASSAY (ELISA)

PROCEDURES/SolidPhase

USP42- NF37Second Supplement to USP41- NF36

Line 7 of Coating the Solid Phase Immobilization of Capture Reagent: Change1-10 µg/well to: 1-10 µg/mL

BRETYLIUM TOSYLATE IN DEXTROSE INJECTION Identification


Line 1 of B: Change It responds to the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

DOBUTAMINE IN DEXTROSE INJECTION Identification


Line 1 of B: Change It meets the requirements for the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification


Line 1 of A: Change It responds to the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

ECHINACEA ANGUSTIFOLIA IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside ANDdicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to:Standard solution B shows two major blue bands at about the middle ofthe chromatogram due to caftaric acid (higher RF) AND chlorogenic acid(lower RF) that are clearly separated, ANDLine 3 of C.: Change Standard solution B; to: Standard solution C;

ECHINACEA PALLIDA IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside ANDabsence of dicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated,to: Standard solution B shows two major blue bands at about the middleof the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 AND 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution C) to: Standard solution D)

ECHINACEA PURPUREA AERIAL PARTS IDENTIFICATION


Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid ANDabsence of echinacoside/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA PURPUREA ROOT IDENTIFICATION


Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid ANDabsence of echinacoside/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA SPECIES DRY EXTRACT CAPSULES IDENTIFICATION


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two majorblue bands at about the middle section due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA SPECIES DRY EXTRACT TABLETS IDENTIFICATION


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two majorblue bands at about the middle section due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA SPECIES POWDER CAPSULES IDENTIFICATION


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome AND roots/System suitability: Change Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated,to: Standard solution B shows two major blue bands at about the middlesection due to caftaric acid (higher RF) AND chlorogenic acid (lower RF)that are clearly separated,

ESZOPICLONEADDITIONAL REQUIREMENTS/USP Reference Standards<11>


Line 2 of USP Eszopiclone Related Compound A RS: Change 6-(5- Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4- methylpiperazine-1-carboxylate 4-oxide.C17H17ClN6O4 404.81 to: [Note: This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H- pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide. C17H17ClN6O4 404.81 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H- pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3- chlorobenzoic salt (1:1). C17H17ClN6O4 · C7H5ClO 561.38

ESZOPICLONE TABLETSADDITIONAL REQUIREMENTS/USP Reference Standards<11>


Line 2 of USP Eszopiclone Related Compound A RS: Change 6-(5- Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4- methylpiperazine-1-carboxylate 4-oxide. C17H17ClN6O4 404.81to: [Note—This material may be available in the free base or salt form.]6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5 yl 4-methylpiperazine-1-carboxylate 4-oxide. C17H17ClN6O4 404.81 6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H- pyrrolo[3,4-b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate 4-oxide, 3 chlorobenzoic salt (1:1). C17H17ClN6O4 · C7H5ClO 561.38

L104 CHROMATOGRAPHIC COLUMNS/Packings


Add L104—Triazol groups chemically bonded to porous silica particles,1.5-10 —m in diameter.

LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION Identification



CHM1 Shankari Shivaprasad Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

NBDS Natalia Davydova Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

CHM4 Claire Chisolm Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

BDSHM Nam-Cheol Kim Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018







CHM4 Claire Chisolm Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

CHM2 Donald Min Errata Revision n/a n/a 1/26/2018 1/26/2018 1/2/2018 1/1/2018

CLINDAMYCIN PHOSPHATE CHM1 Ramanujam Prasad Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

OLMESARTAN MEDOXOMIL TABLETS CHM2 Donald Min Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

POWDERED VALERIAN BDSHM Anton Bzhelyansky Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

POWDERED VALERIAN EXTRACT BDSHM Anton Bzhelyansky Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

REAGENTS, INDICATORS AND SOLUTIONS HDQ Margareth Marques Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

VALERIAN BDSHM Anton Bzhelyansky Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

VALERIAN TABLETS BDSHM Natalia Davydova Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

VALERIAN TINCTURE BDSHM Anton Bzhelyansky Errata Revision n/a n/a 12/29/2017 12/29/2017 1/1/2018 1/1/2018

CHM2 Donald Min Errata Revision n/a n/a 1/26/2018 1/26/2018 2/1/2018 Line 3 of USP Timolol Related Compound D RS: Change C6H9N7O4S to: C6H9N3O2S 1/1/2018PROCEDURES/Solid Phase

GCBA

Kamalpreet Arora Errata Revision n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION

CHM2

Edith Chang Errata Revision n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION

CHM2


DOPAMINE HYDROCHLORIDE AND DEXTROSE INJECTION IDENTIFICATION

CHM2


NEVIRAPINE TABLETSIMPURITIES/OrganicImpurities


Line 1 of Standard solution: Change 0.125 —g/mL of USP NevirapineAnhydrous RS from Standard stock solution A in Diluentto: 0.125 —g/mL of USP Nevirapine Anhydrous RS in Diluent

NIACIN EXTENDED- RELEASE TABLETS ASSAY/Procedure


Line 3 of System suitability: ChangeTable 4 to: Table 13

PHENYTOIN ORAL SUSPENSIONPERFORMANCE TESTS/Dissolution<711>


In the Analysis: Change CS = concentration of USP Phenytoin RS in the Standard solution to: CS = concentration of USP Phenytoin RS in the Standard solution (mg/mL)

POWDERED DIGITALIS IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test


Line 3 of Standard solution A: Change lead acetate,to: lead acetate TS, AND Line 11 of Analysis: Change Locate the two prominent bands from Standard solution A corresponding in RF value to the two bands from Standard solution B. to: Locate the prominent bands from Standard solution A corresponding in RF value to the band from Standard solution B.

POWDERED ECHINACEA ANGUSTIFOLIA IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside AND dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated,to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated, AND Line 3 of C.: Change Standard solution B, to: Standard solution C,

POWDERED ECHINACEA ANGUSTIFOLIA EXTRACT IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside ANDdicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to:Standard solution B shows two major blue bands at about the middle ofthe chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated, AND Line 3 of C.: Change Standard solution B; to: Standard solution C;

POWDERED ECHINACEA PALLIDA IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside ANDabsence of dicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 AND 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution C) to: Standard solution D)

POWDERED ECHINACEA PALLIDA EXTRACT IDENTIFICATION


Line 5 of A. Thin-Layer Chromatography/Presence of echinacoside ANDabsence of dicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) AND chlorogenic acid (higher RF) that are clearly separated,to: Standard solution B shows two major blue bands at about the middleof the chromatogram due to caftaric acid (higher RF) AND chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 AND 6 of C.: Change Standard solution B, to:Standard solution C, AND Change Standard solution C) to: Standard solution D)

POWDERED ECHINACEA PURPUREA IDENTIFICATION



POWDERED ECHINACEA PURPUREA EXTRACT IDENTIFICATION



QUETIAPINE EXTENDED- RELEASE TABLETSIMPURITIES/OrganicImpurities


Footnote a of Table 5: Changetotal impurities.to: total degradation products.AND Footnote b: Change total impurities.to: total degradation products.

TIMOLOL MALEATEADDITIONAL REQUIREMENTS/USP Reference Standards<11>


Line 2 of USP Timolol Related Compound A RS: Change(R)-1-(tert-Butylamino)-3-(4-morpholino-1,2,5-thiadiazol-3- yloxy)propan-2-ol. C13H24N4O3S 316.42 to: (R)-1-(tert-Butylamino)-3-(4- morpholino-1,2,5-thiadiazol-3-yloxy)propan-2-ol maleate. C13H24N4O3S · C4H4O4 432.49 AND Line 2 of USP Timolol Related Compound C RS: Change N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3- yloxy)propan-1-amine. C19H31N7O4S2 485.19 to: N-(tert-Butyl)-2,3-bis(4-morpholino-1,2,5-thiadiazol-3-yloxy)propan-1-amine maleate. C19H31N7O4S2 — C4H4O4 601.69 AND Line 3 of USP Timolol Related Compound D RS: Change C6H9N7O4S to: C6H9N3O2S AND Line 2 of USP Timolol Related Compound E RS: Change(S)-3-(tert-Butylamino)-1-(4-morpholino-1,2,5-thiadiazol-3- yloxy)propan-2-yl hydrogen maleate. C17H26N4O6S 414.48 to: (S,Z)-4- ({1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3- yl)oxy]propan-2-yl}oxy)-4-oxobut-2-enoic acid maleate salt (1:1) C17H26N4O6S — C4H4O4 530.55


USP42-NF37 (Print)USP 41-NF 36 2S (Online)

Footnote e and f: Change e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-ethylpyrrolidine-2-carboxamido]-1-thio-L-threo-?-D-galacto-octopyranoside 3-phosphate. f Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-D-threo-?-D-galacto-octopyranoside. to: e Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-?-D-galacto-octopyranoside 3-phosphate. Methyl 7-chloro-6,7,8-trideoxy-6-[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carboxamido]-1-thio-L-threo-?-D-galacto-octopyranoside.

ASSAY/Chromatographic system

USP42-NF37 (Print)USP 41-NF 36 2S (Online) Line 1 of Detector: Change Identification B to: Identification A

IDENTIFICATION/C. Thin-Layer Chromatography


Line 2 of Chromatographic system/Developing solvent system: Change acetic acid to: glacial acetic acid AND Line 2 of Chromatographic system/Derivatization reagent B: Change acetic acid to: glacial acetic acid

IDENTIFICATION/A. Thin-Layer Chromatography



Solutions/Test Solutions/3. Solutions Prepared Fresh

USP42-NF37 (Print)USP 41-NF 36 2S (Online) Line 2 of 0.06 M Phosphoric Acid TS: Change volumetric flask to: 1000-mL volumetric flask

IDENTIFICATION/C. Thin-Layer Chromatography









TIMOLOL MALEATE TABLETSADDITIONAL REQUIREMENTS/USP Reference Standards<11>

USP42- NF37 (Print)Second Supplement to USP41- NF36 (Online)

<1103> IMMUNOLOGI CAL TEST METHODS– ENZYME- LINKED IMMUNOSORB ENT ASSAY (ELISA)

2018-02-01


Line 7 of Coating the Solid Phase– Immobilization of Capture Reagent: Change 1-10 µg/well to: 1-10 µg/mL

BRETYLIUM TOSYLATE IN DEXTROSE INJECTION 2018-02-01



DOBUTAMINE IN DEXTROSE INJECTION 2018-02-01


Line 1 of B: Change It meets the requirements for the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

2018-02-01


Line 1 of A: Change It responds to the Identification test under Dextrose. to: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

IDENTIFICATION

BDSHM

Anton Bzhelyansky Errata Revision n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM

Anton Bzhelyansky Errata n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM

Natalia Davydova Errata Revision n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM



CHM4

Heather Joyce Errata Revision n/a n/a 2/23/2018 2/23/2018


CHM4

Heather Joyce Errata Revision n/a n/a 2/23/2018 2/23/2018

CHROMATOGRAPHIC COLUMNS/Packings

HDQ

Margareth Marques Errata Revision n/a n/a 2/23/2018 2/23/2018 Add L104–Triazol groups chemically bonded to porous silica particles, 1.5-10 µm in diameter.

IDENTIFICATION

CHM5

Gerald Hsu Errata Revision n/a n/a 2/23/2018 2/23/2018


CHM1

Shankari Shivaprasad Errata Revision n/a n/a 2/23/2018 2/23/2018

ASSAY/Procedure

NBDS


PERFORMANCE TESTS/Dissolution <711>

CHM4

Claire Chisolm Errata Revision n/a n/a 2/23/2018 2/23/2018

IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test

BDSHM

Nam-Cheol Kim Errata Revision n/a n/a 2/23/2018 2/23/2018

POWDERED ECHINACEA ANGUSTIFOLIA IDENTIFICATION

BDSHM


POWDERED ECHINACEA ANGUSTIFOLIA EXTRACT IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM


ECHINACEA ANGUSTIFOLI A 2018-02-01


Line 5 of A. Thin- Layer Chromatography/Presence of echinacoside and dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Line 3 of C.: Change Standard solution B; to: Standard solution C;

ECHINACEA PALLIDA 2018-02-01


Line 5 of A. Thin- Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 and 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution C) to: Standard solution D)

ECHINACEA PURPUREA AERIAL PARTS 2018-02-01


Line 3 of A. Thin-Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA PURPUREA ROOT 2018-02-01


Line 3 of A. Thin- Layer Chromatography/Pre sence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due

ECHINACEA SPECIES DRY EXTRACT CAPSULES 2018-02-01


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia Dry Extract/System suitability: Change Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated,

ECHINACEA SPECIES DRY EXTRACT TABLETS 2018-02-01


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Tablets containing Echinacea angustifolia Dry Extract/System suitability: Change Standard solution B shows two major blue bands at about the middle section

ECHINACEA SPECIES POWDER CAPSULES 2018-02-01


Line 4 of A. HPTLC for Articles of Botanical Origin <203>/For Capsules containing Echinacea angustifolia powder prepared from dried rhizome and roots/System suitability: Change Standard solution B shows two major blue bands at about the middle section due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle section due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated,

ESZOPICLONE 2018-02-01


Line 2 of USP Eszopiclone Related Compound A RS: Change 6-(5-Chloropyridin-2-yl)-7-oxo-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-yl 4- methylpiperazine-1- carboxylate 4-oxide. C17H17ClN6O4 404.81 to: [Note–This material may be available in the free base or salt form.] 6-(5-Chloropyridin-2-yl)-7-oxo-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-yl 4- methylpiperazine-1- carboxylate 4-oxide. C17H17ClN6O4 404.81 6-(5-Chloropyridin-2-yl)-7-oxo-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-yl 4- methylpiperazine-1- carboxylate 4-oxide, 3-chlorobenzoic salt (1:1). C17H17ClN6O4 · C7H5ClO 561.38

ESZOPICLONE TABLETS 2018-02-01


Line 2 of USP Eszopiclone Related Compound A RS: Change 6-(5-Chloropyridin-2-yl)-7-oxo-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-yl 4-

L104 2018-02-01


LIDOCAINE HYDROCHLOR IDE AND DEXTROSE INJECTION 2018-02-01



NEVIRAPINE TABLETS 2018-02-01


Line 1 of Standard solution: Change 0.125 µg/mL of USP Nevirapine Anhydrous RS from Standard stock solution A in Diluent to: 0.125 µg/mL of USP Nevirapine Anhydrous RS in Diluent

NIACIN EXTENDED- RELEASE TABLETS 2018-02-01


Line 3 of System suitability: Change Table 4 to: Table 13

PHENYTOIN ORAL SUSPENSION 2018-02-01


In the Analysis: Change CS = concentration of USP Phenytoin RS in the Standard solution to: CS = concentration of USP Phenytoin RS in the Standard solution (mg/mL)

POWDERED DIGITALIS 2018-02-01


Line 3 of Standard solution A: Change lead acetate, to: lead acetate TS, AND Line 11 of Analysis: Change Locate the two prominent bands from Standard

2018-02-01


Line 5 of A. Thin- Layer Chromatography/Pre sence of echinacoside and dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Line 3 of C.: Change Standard solution B, to: Standard solution C,

2018-02-01


Line 5 of A. Thin- Layer Chromatography/Pre sence of echinacoside and dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Line 3 of C.: Change Standard solution B; to: Standard solution C;

POWDERED ECHINACEA PALLIDA 2018-02-01


Line 5 of A. Thin- Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 and 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution to: Standard solution D)

POWDERED ECHINACEA PALLIDA EXTRACT 2018-02-01


Line 5 of A. Thin- Layer Chromatography/Presence of echinacoside and absence of dicaffeoylquinic acid/System suitability: ChangeStandard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 and 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution C) to: Standard solution D)

IDENTIFICATION

BDSHM


IDENTIFICATION

BDSHM


QUETIAPINE EXTENDED- RELEASE TABLETS IMPURITIES/Organic Impurities

CHM4

Claire Chisolm Errata Revision n/a n/a 2/23/2018 2/23/2018


CHM2

Donald Min Errata Revision n/a n/a 2/23/2018 2/23/2018


CHM2

Donald Min Errata Revision n/a n/a 2/23/2018 2/23/2018 Line 3 of USP Timolol Related Compound D RS: Change C6H9N7O4S to: C6H9N3O2S

Steven Walfish Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018C. AERODYNAMIC SIZE DISTRIBUTION/INHA LATION AEROSOLS, SPRAYS, AND POWDERS

GCDF2015

Kahkashan Zaidi Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

BIO42015

Ying Han Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

CHM22015

Edith Chang Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

CHM22015


3/26/2018

CHM22015


3/26/2018

CHM32015

Morgan Puderbaugh Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

CHM22015

Donald Min Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

CHM22015

Donald Min Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

CHM42015

Gerald Hsu Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018IMPURITIES/Organic Impurities, Procedure 2/Table 3

CHM12015

Ramanujam Prasad Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

HDQ

Margareth Marques Errata Revision n/a n/a 3/30/18 3/30/18 3/1/18

3/26/2018

<661.1> PLASTIC MATERIALS OF CONSTRUCTION TEST METHODS/Tin in Non-Tin-Stabilized Materials GCPD2015 Desmond Hunt Errata Revision n/a n/a 4/27/2018 4/27/2018 4/1/2018 USP42-NF37

POWDERED ECHINACEA PURPUREA 2018-02-01


Line 3 of A. Thin- Layer Chromatography/Presence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two majorblue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated, AND Lines 3 and 6 of C.: Change Standard solution B, to: Standard solution C, AND Change Standard solution C) to: Standard solution D)

POWDERED ECHINACEA PURPUREA EXTRACT 2018-02-01


Line 3 of A. Thin- Layer Chromatography/Pre sence of chicoric acid and absence of echinacoside/System suitability: Change Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (lower RF) and chlorogenic acid (higher RF) that are clearly separated, to: Standard solution B shows two major blue bands at about the middle of the chromatogram due to caftaric acid (higher RF) and chlorogenic acid (lower RF) that are clearly separated,

2018-02-01


Footnote a of Table 5: Change total impurities.

TIMOLOL MALEATE 2018-02-01


Line 2 of USP Timolol Related Compound A RS: Change (R)-1-(tert- Butylamino)-3-(4- morpholino-1,2,5- thiadiazol-3- yloxy)propan-2-ol. C13H24N4O3S 316.42 to:(R)-1-(tert- Butylamino)-3-(4- morpholino-1,2,5- thiadiazol-3- yloxy)propan-2-ol maleate. C13H24N4O3S · C4H4O4 432.49 AND Line 2 of USP Timolol Related Compound C RS: Change N-(tert-Butyl)-2,3- bis(4-morpholino-1,2,5-thiadiazol-3- yloxy)propan-1- amine. C19H31N7O4S2 485.19 to: N-(tert-Butyl)-2,3- bis(4-morpholino-1,2,5-thiadiazol-3- yloxy)propan-1- amine maleate.

TIMOLOL MALEATE TABLETS 2018-02-01


<1210> STATISTICAL TOOLS FOR PROCEDURE VALIDATION 3. ACCURACY AND PRECISION/3.1Methods for Estimating Accuracy and Precision

GCSTAT2015

USP42- NF37Online: Second Supplement to USP41-NF36

Paragraph 4: ChangeFor example, withα = 0.05 and n =9, t0.95:8 = 1.860 provides a 100(1-2 × 1.05)%to:For example, with? = 0.05 and n =9, t0.95:8 = 1.860 provides a 100(1 -2 × 0.05)%

<601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS?PERFOR MANCE QUALITY TESTS


Figure 6: Change Boquilla del Inhaladorto:Inhaler MouthpieceAND ChangeTubo de Admisión to:Induction PortAND ChangeCono de Ingreso to:Entrance Cone

<81> ANTIBIOTICS?MIC ROBIAL ASSAYS CALCULATIONS/Turbidimetric Assay/Sample Data USP42- NF37Online: Second Supplement to USP41-NF36

Second equation inStep 1: Change0.0125 =to:0.0062 = ANDThird equation inStep 1: Change0.0325 =to:0.0322 =

AMLODIPINE AND ATORVASTATIN TABLETS IMPURITIES/Organic Impurities Related to Atorvastatin USP42- NF37Online: Second Supplement to USP41-NF36

In the variable definition list in Analysis: Change Mr2 = molecular weight of atorvastatin calcium, 1209.39 to:Mr2 = molecular weight of atorvastatin calcium, 1155.34

AMLODIPINE AND ATORVASTATIN TABLETS PERFORMANCE TESTS/Dissolution<711>


In the variable definition list of the second equation in Analysis: Change Mr2 = molecular weight of atorvastatin calcium, 1209.39 to:Mr2 = molecular weight of atorvastatin calcium, 1155.34

AMLODIPINE AND ATORVASTATIN TABLETS ASSAY/Procedure USP42- NF37Online: Second Supplement to USP41-NF36

In the variable definition list of the second equation in Analysis: Change Mr2 = molecular weight of atorvastatin calcium, 1209.39 to:Mr2 = molecular weight of atorvastatin calcium, 1155.34

CHLORHEXIDINE GLUCONATE ORAL RINSE Identification USP42- NF37Online: Second Supplement to USP41-NF36

Line 1 of C: ChangeUndiluted Oral Rinse used as the test solution meets the requirements for Identification test B under Calcium Gluconate, except that a Standard solution containing about 0.6 mg of USP Potassium Gluconate RS per mL is used and 15 µL of the test solution and the Standard solution are applied to the thin-layer chromatographic plate.to:Use undiluted Oral Rinse as the test solution and prepare a Standard solution of USP Potassium Gluconate RS in water containing 0.6 mg/mL. Apply separate 15-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography <621>) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50:30:10:10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110° for 20 minutes. Allow to cool and spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110° for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and RF value to that obtained from the Standard solution.

NOREPINEPHRINE BITARTRATE ASSAY/Procedure USP42- NF37Online: Second Supplement to USP41-NF36

Line 1 of Sample solution: Change25 mg/mL of Norepinephrine Bitartrate in glacial acetic acid. If necessary warm slightly to effect solution.to:Dissolve 500 mg of Norepinephrine Bitartrate in 20 mL of glacial acetic acid, warming slightly ifnecessary to effect solution.

NOREPINEPHRINE BITARTRATE IDENTIFICATION/B. Procedure USP42- NF37Online: Second Supplement to USP41-NF36

Line 1 of Analysis: ChangeAdd 1 drop of ferric chloride TS.to:Add 1 drop of ferric chloride TS to 2 mL of Sample solution.

PAROXETINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards<11>


Line 1 of USP Paroxetine Related Compound F RS: Changetrans(-)-1-Methyl-3-[1,3- benzodioxol-5- yloxy)methyl]-4- (fluorophenyl)piper idine.to:(3S,4R)-3- [(Benzodioxol-5- yloxy)methyl]-4-(4-fluorophenyl)-1- methylpiperidine.

PIPERACILLIN AND TAZOBACTAM FOR INJECTION USP42- NF37Online: Second Supplement to USP41-NF36

Footnote m: Change (2S,5R,6R)-Ethyl6-((R)-2-{(2S,5R,6R)-6- [(R)-2-(4-ethyl-2,3- dioxopiperazine-1- carboxamido)-2- phenylacetamido]-3,3-dimethyl-7- oxo-4-thia-1- azabicyclo[3.2.0]h eptane-2- carboxamido}-2- phenylacetamido)-3,3-dimethyl-7- oxo-4-thia-1- azabicyclo[3.2.0]h eptane-2- carboxylate.to:2-(((3-Acetyl-4- (ethoxycarbonyl)-5,5- dimethylthiazolidin-2- yl)methyl)amino)-2-oxo-1- phenylethyl 6-(2- (4-ethyl-2,3- dioxopiperazine-1- carboxamido)-2- phenylacetamido)-3,3-dimethyl-7- oxo-4-thia-1- azabicyclo[3.2.0]h eptane-2- carboxylate.

REAGENTS REAGENT SPECIFICATIONS USP42- NF37Online: Second Supplement to USP41-NF36

Line 2 of 9Z- Retinoic Acid: Change Acidalitretinoin), to:Alitretinoin),

Line 3 of Sample solution: Change If the solution is not colorless, add the sodium sulfateto:If the solution is not colorless, add the sodium sulfite

ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM42015 Ravi Ravichandran Errata Revision n/a n/a 4/27/2018 4/27/2018 4/1/2018 USP42-NF37

PERINDOPRIL ERBUMINE IMPURITIES/Limit of Perindopril Related Compound I/System suitability CHM22015 Donald Min Errata Revision n/a n/a 4/27/2018 4/27/2018 4/1/2018 USP42-NF37

SALMETEROL INHALATION POWDER ADDITIONAL REQUIREMENTS/USP Reference Standards <11> CHM42015 Ravi Ravichandran Errata Revision n/a n/a 4/27/2018 4/27/2018 4/1/2018 USP42-NF37

FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER

Line 2 of USP Salmeterol Related Compound H RS: Change1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.C36H43NO6 585.73to:1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.

Line 3: Add[Note: The relative retention times for perindopril and perindopril related compound I are 1.0 and 1.6, respectively.]

Line 2 of USP Salmeterol Related Compound H RS: Change1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid.C36H43NO6 585.73to:1-Hydroxy-4-[2-hydroxy-5-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)benzyl]-2-naphthoic acid, monohydrate.C36H43NO6 · H2O 603.76