catalogue analytical services - solvias...page 1 february 2020 catalogue analytical services general...

www.solvias.com February 2020

Catalogue Analytical Services

General remarks 2

Chromatography and Separation Techniques 3

Elements, Metals and Heavy Metals 5

Microbiology 9

Microscopy 12

Molecular Biology and DNA-Sequencing 13

Packaging Material and Medical Devices 15

Particle Determination and Characterization 16

Pharmacopoeial Tests 18

Physico-Chemical Parameters and Solid State Properties 20

Proteins and Peptides: Analysis of Biopharmaceuticals 22

Spectroscopy and Structure Elucidation 24

Stability Studies and Release Testing 25

Index 26

Contents


LEGEND OF THE NOTES IN THIS DOCUMENTTimelines

[1] Delivery times apply as outlined below.[2] The delivery date will be arranged in agreement with the customer.

Subcontracting[3] Analysis will be performed by a qualified contract laboratory[4] Analysis will be performed by our subsidiary Confarma France SAS

DELIVERY TIMES AND RESPECTIVE SURCHARGES FOR SERVICES WITH NOTE [1]• Standard: within 10 business days• Urgent: within 5 business days• Express: 2 business days (subject to prior notification)Large series of samples cannot always be measured within these delivery times, and will be processed in the technically feasible cycle time.

HIGHLY ACTIVE, HIGHLY TOXIC, LIGHT-SENSITIVE OR CONTROLLED SUBSTANCES AND NARCOTICSSolvias is equipped to handle highly toxic, highly active materials (HIPO/HAPI), light-sensitive samples as well as narcotics/controlled substances.

QUALITY AND GMP COMPLIANCE• Good Manufacturing Practices (GMP) certified• Solvias site Kaiseraugst (CH): FDA approved (FEI 300 873 5083, DUNS 480739627)• Confarma site Hombourg (F): FDA approved (FEI 300 280 6657, DUNS 492738125)• ISO 9001:2008 certifiedFurther information and current certificates are available on our website (www.solvias.com).

ORDER PLACEMENTThe General Terms and Conditions of Solvias AG apply unless agreed otherwise in writing. We ask for your understanding that Solvias can only accept orders which are placed together with the following information, because of quality requirements: • Completed Solvias order form (see “Order Forms” at www.solvias.com) and safety information

(e.g. MSDS) need to be enclosed to your sample shipment.• Submission of a purchase order number is a prerequisite for us to start working on your order.• Please send samples for analysis to the following address:

Solvias AG, Sample Registration, Römerpark 2, 4303 Kaiseraugst, Schweiz

General remarks

CONTACT HEADQUARTERSSolvias AG, Römerpark 2, 4303 Kaiseraugst, SwitzerlandTel. +41 61 845 60 00, [email protected]

CONTACT NORTH AMERICASolvias Inc., 2125 Center Avenue, Suite 507, Fort Lee, NJ, 07024, USATel. +1 201 302 6084 / toll free 866-4-SOLVIAS, [email protected]


Chromatography and Separation Techniques

Service/Parameter Required Substance

Unit Handling of HIPO

Note

Gas chromatography (GC)GC & HEADSPACE GC (FID, TCD, MSD)

Identity, Assay, Related Substances, Degradation products on request method yes [2]

Feasibility Study, Method Development, Method Validation or Verification on request method yes [2]

Routine analysis on request analysis yes [2]

GC-MS

GC-MS screening for volatile compounds on request analysis yes [2]

GC-MS screening for non-volatile compounds on request analysis yes [2]

RESIDUAL SOLVENTS BY GC HEADSPACE


Routine analysis acc. to Compendial methods (Ph. Eur., USP): 200 mg analysis yes [2]

High pressure liquid chromatography (HPLC, UPLC)HPLC-UV, -DAD, -FLD, -RI, -ELSD, -ECD, -MALLS, -DLS, -AF4

Identity, Assay, Related Substances, Degradation products on request method yes [2]



HPLC-MS, HPLC-MS/MS (ESI, APCI)

Feasibility Study, Method Development, Method Validation or Verification on request method on request [2]

Routine analysis on request analysis on request [2]

Ion chromatography (IC)SOLVIAS STANDARD METHODS, BASED ON USP METHOD <1065>


Determination of anions or cations e.g. in solids, organic matrices etc. with standard calibration <duplicate determination> (recommended)

50 mg analysis yes [1]

Determination of anions or cations e.g. in solids, organic matrices etc. with standard calibration <single determination>


CUSTOMER-SPECIFIC, MATRIX-SPECIFIC METHODS

Determination of anions or cations with complex calibration on request analysis yes [1]

Method development and validation according ICH Guidelines on request method yes [2]

SEMIQUANTITATIVE SCREENING OF IONS

Package of cations: Na+, K+, Mg2+, Ca2+, NH4+ 20 mg analysis yes [1]

Package of anions 1: Cl-, NO2-, NO3-, Br-, PO43-, SO42- 20 mg analysis yes [1]

Package of anions 2: formate, acetate, trifluoroacetate, oxalate 20 mg analysis yes [1]




Note

Thin layer chromatography (TLC)TLC ANALYSIS ACC. TO COMPENDIAL METHODS (PH. EUR., USP)

Identification 1 - 2 g analysis no [1]

Semi-quantitative/quantitative determination on request analysis no [1]

TLC ANALYSIS ACC. TO CUSTOMER METHOD

Identity test 1 - 2 g analysis no [1]

Semi-quantitative/quantitative determination on request analysis no [1]

Capillary and gel electrophoresisCAPILLARY AND GEL ELECTROPHORESIS

Identity, Assay, Related Substances, Degradation products on request method on request [2]

Feasibility Study, Method Development, Method Validation or Verification on request method on request [2]

Routine analysis on request analysis on request [2]

SpecialtiesANALYSIS OF TWEEN

Feasibility study for the quantitative determination of Tween on request product yes [2]

Method development after successful feasibility study on request product yes [2]

Method validation on request product yes [2]


NITROSAMINES on request product yes [2]


Elements, Metals and Heavy Metals: Identification, Quantification, Screening and Trace Analysis



Note

Elemental analysis: Quantification of elements in percentage and trace levelDETERMINATION OF TOTAL CONTENT (SINGLE OR IN COMBINATION) BY COMBUSTION ANALYSIS AND RELATED ROUTINE DETERMINATIONS

Only duplicate determination

Bromide (Br-) 8 - 20 mg analysis yes [1]

Bromine (Br) 8 - 20 mg analysis yes [1]

Carbon (C) 4 - 10 mg analysis yes [1]

Chloride (Cl-) 4 - 10 mg analysis yes [1]

Chlorine (Cl) 4 - 10 mg analysis yes [1]

CHN 4 - 10 mg analysis yes [1]

CHNS 4 - 10 mg analysis yes [1]

CHNO 8 - 20 mg analysis yes [1]

CHNSO 8 - 20 mg analysis yes [1]

Fluoride (F-) 8 - 20 mg analysis yes [1]

Fluorine (F) 8 - 20 mg analysis yes [1]

Hydrogen (H) 4 - 10 mg analysis yes [1]

Iodide (I-) 12 - 30 mg analysis yes [1]

Iodine (I) 12 - 30 mg analysis yes [1]

Nitrogen (N) 4 - 10 mg analysis yes [1]

Nitrogen (N), Kjeldahl: Set up / Verification of the method, incl. analysis of one sample (pharmacopoeial methods)

10 mg - 10 g analysis yes [1]

Nitrogen (N), Kjeldahl: additional samples within the same series (pharmacopoeial methods)

10 mg - 10 g analysis yes [1]

Oxygen (O) 4 - 10 mg analysis yes [1]

Sulfur (S) 4 - 10 mg analysis yes [1]

Single determination

Carbonate in water and liquid samples by IR on request analysis yes [1]

Total nitrogen (TN) on request

Total organic carbon (TOC) 50 - 100 ml analysis yes [1]

DETERMINATION OF SINGLE/MULTIPLE ELEMENTS BY ICP-OES AFTER DECOMPOSITION BY DIGESTION (TRACE OR PERCENTAGE LEVELS)

Duplicate determination (recommended) 400 mg analysis yes [1]

Single determination 200 mg analysis yes [1]

ICP-OES of aqueous solutions (no matrix) without decomposition step on request analysis yes [1]

Analysis of halogens, halogenides acc. to product specific methods on request analysis yes [1]


Service/Parameter RequiredSubstance

Unit Handlingof HIPO

Note

DETERMINATION OF SINGLE/MULTIPLE ELEMENTS BY ICP-MS AFTER DECOMPOSITION BY DIGESTION (TRACE LEVELS)


Duplicate determination Osmium (Os) 80 mg analysis yes [1]


Single determination Osmium (Os) 40 mg analysis yes [1]

ICP-MS of aqueous solutions (no matrix) without decomposition step on request analysis yes [1]

Additional SST according to JP <2.63> on request analysis yes [1]

DETERMINATION OF SINGLE/MULTIPLE ELEMENTS BY X-RAY FLUORESCENCE (XRF), WITHOUT HALOGENS, S, P, SI, SN, PD

Single determination 2.5 g analysis no [1]

Sample preparation (milling) 2.7 g sample no [1]

DETERMINATION OF HALOGENS, S, P, SI, SN, PD BY X-RAY FLUORESCENCE (XRF)

Special elements: e.g. Halogens, S, P, Si, Sn, Pd <single determination> 2.5 g / 2.5 mL element no [1]

Silicium incl. sample preparation (milling) 2.7 g analysis no [1]

DETERMINATION OF SINGLE/MULTIPLE ELEMENTS BY FLAME ATOMIC ABSORPTION SPECTROMETRY (FAAS) (ROUTINE METHOD)

1 element, without decomposition step <duplicate determination> (recommended)


1 element, with decomposition step <duplicate determination> (recommended)


1 element, without previous decomposition <single determination> 200 mg analysis yes [1]

1 element, with decomposition step <single determination> 200 mg analysis yes [1]

ELECTROTHERMAL OR COLD VAPOUR ATOMIC ABSORPTION SPECTROMETRY (ETAAS, CVAAS)

Elemental determination by graphite furnace AAS, Hg with cold vapor technique


SPECTROMETRY, SPECIAL ANALYSIS

Precise assay (%-range) by ICP-OES or FAAS including verification with reference standard <duplicate determination> (recommended)


Precise assay (%-range) by ICP-OES or FAAS including verification with reference standard <single determination>


Determination after special decomposition (e.g. Si by ICP-OES or FAAS) <duplicate determination> (recommended)


Determination after special decomposition (e.g. Si by ICP-OES or FAAS) <single determination>


Spectrometric methods with standard addition (ICP-OES or FAAS) <duplicate determination> (recommended)


Spectrometric methods with standard addition (ICP-OES or FAAS) <single determination>





Note

Pharmacopoeial methodsEUROPEAN PHARMACOPOEIA: HEAVY METALS ACC. TO PH. EUR. 2.4.8.

Method A, B, C, D, E, F 2 - 4 g analysis yes [1]

UNITED STATES PHARMACOPOEIA: HEAVY METALS ACC. TO USP <231>

Method I, II, II 2 - 4 g analysis yes [1]

JAPANESE PHARMACOPOEIA: HEAVY METALS ACC. TO JP 1.07

Method 1, 2, 3, 4 2 - 4 g analysis yes [1]

PHARMACOPOEIA METHODS: GRAVIMETRIC ANALYSIS

Loss on drying / dry mass (Ph. Eur. 2.2.32., USP <731>) 1 g analysis yes [1]

Loss on drying / dry mass micro-method from 100 mg analysis yes [1]

Sulphated ash (Ph. Eur. 2.4.14., USP <281>) from 1 g analysis yes [1]

Sulphated ash micro-method from 100 mg analysis yes [1]

Total ash / Loss on ignition (Ph. Eur. 2.4.16., USP <733>) from 100 mg analysis yes [1]


Quantitative heavy metal screenings QUANTITATIVE SCREENING BY ICP-MS COVERING ELEMENTS LISTED IN ICH Q3D, USP <232>, PH. EUR. 5.20 AND EMEA, EXCEPT FOR OS, PLUS ADDITIONAL FREQUENTLY REQUESTED ELEMENTS (TRACE ANALYSIS, LOQS 0.01 - 0.5 MG/KG)

33 elements: Ag, Al, As, Au, B, Ba, Cd, Ce, Co, Cr, Cs, Cu, Fe, Hg, Ir, Li, Mn, Mo, Ni, Pb, Pd, Pt, Rh, Ru, Sb, Se, Sn, Ti, Tl, V, W, Zn, Zr



QUANTITATIVE SCREENING BY ICP-MS FOR ELEMENTS LISTED IN USP <232> AND EMEA, EXCEPT OS (TRACE ANALYSIS, LOQS 0.01 - 0.5 MG/KG)

17 elements: As, Cd, Cr, Cu, Fe, Hg, Ir, Mn, Mo, Ni, Pb, Pd, Pt, Rh, Ru, V, Zn



QUANTITATIVE SCREENING BY ICP-MS COVERING ELEMENTS DETECTABLE BY USP <231> (TRACE ANALYSIS, LOQS 0.1 MG/KG)

10 elements: Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, Sn 200 mg analysis yes [1]

QUANTITATIVE SCREENING BY ICP-MS “BIG FOUR”/CLASS 1 (LOQS 0.01 MG/KG FOR CD, PB AND 0.05 MG/KG FOR AS, HG)

4 elements As, Cd, Hg, Pb <duplicate determination> 400 mg analysis yes [1]

4 elements As, Cd, Hg, Pb <single determination> 200 mg analysis yes [1]

OTHER QUANTITATIVE SCREENINGS BY ICP-MS

E.g. according to ICH Q3D or USP <232> or Ph. Eur. 5.20 on request analysis yes [1]

QUANTITATIVE SCREENING BY ICP-OES ACC. TO SOLVIAS METHOD (TRACE ANALYSIS, LOQS 1 MG/KG)

18 elements: Al, As, Ba, Cd, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Pd, Se, Sn, Ti, V, Zn

<duplicate determination> 400 mg analysis yes [1]

<single determination> 200 mg analysis yes [1]

21 elements: Al, As, Ba, Cd, Co, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Pd, Se, Sn, Ti, V, Zn, Bi, Pt, Sb

<duplicate determination> 400 mg analysis yes [1]

<single determination> 200 mg analysis yes [1]

SEMI-QUANTITATIVE OVERVIEW ANALYSIS BY XRF, INCLUDING CLASSIFICATION IN MAJOR/MINOR CONSTITUENTS AND TRACES (LOD APPROX. 10PPM)

Spectrum, Mg (12) - U (92) 1 - 3 g analysis no [1]


Microbiology

Service/Parameter Unit Handling of HIPO

Note

Microbiological tests of non-sterile products MICROBIAL ENUMERATION TESTS ACC. TO PH. EUR. 2.6.12 / USP <61>

Validation including validation protocol, testing, validation report product yes [2], [4]

Total aerobic microbial count (TAMC) and the total combined yeast/moulds count (TYMC) <plate count>

analysis yes [2], [4]

Total aerobic microbial count (TAMC) and the total combined yeast/moulds count (TYMC) <membrane filtration>


TESTS FOR SPECIFIED MICRO-ORGANISMS ACC. TO PH. EUR. 2.6.13 / USP <62>


Bile tolerant gram-negative bacteria, Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans


Other micro-organisms or analyses of pharmaceutical water analysis yes [2], [4]

BACTERIAL ENDOTOXINS TEST ACC. TO PH. EUR. 2.6.14 / USP <85>


Endotoxins (LAL test), turbidimetric kinetic method analysis yes [2], [4]

OTHER RELATED TESTS

Pyrogens acc. to Ph. Eur. 2.6.30 (Monocyte Activation Test | MAT) product yes [2], [4]

Preservative efficacy test / Challenge test acc. Ph. Eur. 5.1.3 / USP <51> product yes [2], [4]

Microbial assay of antibiotics acc. Ph. Eur. 2.7.2 / USP <81> product yes [2], [4]

Minimum inhibitory concentration (MIC) acc. DIN 58940-7 / 58940-83 product yes [2], [4]

Activity of water (aw) acc. Ph. Eur. 2.5.33 / USP <1057> product yes [2], [4]

Microbiological tests of sterile productsSTERILITY TESTING


Sterility acc. Ph. Eur. 2.6.1 / USP <71> / ISO 11737 analysis yes [2], [4]

Rapid sterility testing acc. Ph. Eur. 5.1.6 / USP <1223> / TR#33 analysis yes [2], [4]

BACTERIAL ENDOTOXINS TEST ACC. TO PH. EUR. 2.6.14 / USP <85>


Endotoxins (LAL test), turbidimetric kinetic method analysis yes [2], [4]

OTHER RELATED TESTS

Bioburden (TAMC, TYMC, TAnaMC) acc. Ph. Eur. 2.6.12 / ISO 11737 product yes [2], [4]

Pyrogens (Monocyte Activation Test | MAT) acc. Ph. Eur. 2.6.30 product yes [2], [4]

Low endotoxin recovery studies (LER) product yes [2], [4]

Particulate matter by light obscuration acc. Ph. Eur. 2.9.19 / USP <788>, <787> product yes [2], [4]

Particulate matter by microscope acc. Ph. Eur. 2.9.19 / USP <788> product yes [2], [4]

Mycoplasma detection by qPCR acc. Ph. Eur. 2.6.7 product yes [2], [4]



Note

OTHER RELATED TESTS (CONTINUED)

Media fill test (MFT), incubation and reading product yes [2], [4]

Container closure integrity test (CCIT) product yes [2], [4]

• Dye test (methylene blue), PDA Journal / USP <1207> product yes [2], [4]

• Microbial igress test (MIT), PDA Journal / USP <1207> product yes [2], [4]

D-Value determination for biological indicator and in-house microorganisms acc. USP <550> / ISO 11138

product yes [2], [4]

Microbial assay of antibiotics acc. Ph. Eur. 2.7.2 / USP <81> product yes [2], [4]

H2O2 residues product yes [2], [4]

Pyrogens and endotoxins IN VITRO PYROGEN TEST: MONOCYTE ACTIVATION TEST (MAT) ACC. PH. EUR. 2.6.30

BACTERIAL ENDOTOXIN TEST - ALL METHODS ACC. PH. EUR. 2.6.14 / USP <85>

Gel clot method (method B) product yes [2], [4]

Turbidimetric kinetic (method C) product yes [2], [4]

Chromogenic kinetic (method D) product yes [2], [4]

Alternative method (recombinant factor C) acc. Ph. Eur. 5.1.10 product yes [2], [4]

LOW ENDOTOXIN RECOVERY STUDIES (LER)

Environmental tests (mapping, monitoring, water analysis) ANALYSIS OF PHARMACEUTICAL WATER ACC. PH. EUR., USP AND ISO

Purified water acc. Ph. Eur. 0008 / USP <1231> / ISO 9308 product yes [2], [4]

Highly purified water acc. Ph. Eur. 1927 product yes [2], [4]

Water for injections acc. Ph. Eur. 0169 / USP <1231> product yes [2], [4]

Drinking water acc. USP <1231> / ISO 6222 product yes [2], [4]

OTHER RELATED TESTS

Microbiological monitoring: sampling, intubation, reading, mapping studies, site qualifications mapping (clean room)


Growth promotion test acc. Ph. Eur. 2.6.12, 2.6.13, 2.6.1 product yes [2], [4]

Identification of microorganisms by DNA sequencing product yes [2], [4]

Identification of microorganisms by MALDI-TOF product yes [2], [4]

Cryoconservation of microorganisms for one year (cryoballs) product yes [2], [4]

Preparation of bacterial spores suspension product yes [2], [4]

Disinfectant efficacy studies acc. USP <1072> / ISO 13697, 1042, 1275 product yes [2], [4]

Cleaning validation acc. NF S 94-091 product yes [2], [4]

Incubation and recording of monitoring plates (count-tact plates and settle plates)


Services for your clean processes:

• Gas (compressed air / process air, N2, CO2, CO, O2) product yes [2], [4]

• Room monitoring (active air / passive air, surface / floor, swab, particle count)


• Water systems (drinking water, purified water, water for injection, clean steam)




Note

Cell based bioassays POTENCY / STABILITY ASSAYS ACC. ICH Q2(R1) / USP <1033>

Induction / inhibition of cytokine production product yes [2], [4]

Proliferation / apoptosis product yes [2], [4]

Reporter gene expression assays product yes [2], [4]

Antibody dependent cell-mediated cytotoxicity product yes [2], [4]

OTHER RELATED TESTS

Flow cytometry FACS product yes [2], [4]

Surface Plasmon Resonance | SPR (Biacore) product yes [2], [4]

Biological assaysSingle radial immuno diffusion (SRID) acc. Ph. Eur. 2.7.1 / USP <90> product yes [2], [4]

ELISA (kits and development) acc. ICH Q2(R1) product yes [2], [4]

Host cell proteins (HCP) acc. ICH Q2(R1) product yes [2], [4]

Medical devicesBIOLOGICAL EVALUATION: BIOCOMPATIBILITY ACC. ISO 10993, 17025

Cytotoxicity acc. USP <87> / ISO 10993-5 product yes [2], [4]

MICROBIOLOGICAL TESTING

Sterility testing acc. Ph. Eur. 2.6.1 / USP <71> / ISO 11737 product yes [2], [4]

Bioburden (TAMC, TYMC, TAnaMC) acc. Ph. Eur. 2.6.12 / ISO 11737 product yes [2], [4]

Pyrogens acc. Ph. Eur. 2.6.30, 2.6.8 / USP <151> product yes [2], [4]

Bacterial endotoxin test acc. Ph. Eur. 2.6.14 / USP <85> product yes [2], [4]

STUDIES

Cleaning validation product yes [2], [4]

Residual hydrocarbons (HCT) acc. NF EN ISO 9377-2 product yes [2], [4]

TOC product yes [2], [4]

Sodium hyaluronate acc. Ph. Eur. 1472 product yes [2], [4]

BDDE hyaluronic acid gel product yes [2], [4]

Lidocaine product yes [2], [4]

Total proteins product yes [2], [4]


Microscopy


Note

Imaging and analysis of unknown particles by microscopic techniquesLIGHT MICROSCOPY

Imaging by light microscopy (without preparation, without report) analysis yes [2]

Identity test by light microscopy (without preparation, without report) analysis yes [2]

Light microscopy, direct exposure from suspension, (incl. short report and 2-4 images) analysis yes [2]

Light microscopy, after embedding and sectioning, (incl. short report and 2-4 images) analysis on request [2]

Light microscopy, after special sample preparation analysis no [2]

IR & RAMAN MICROSCOPY

Raman microscopy analysis no [2]

IR microscopic testing, per spectrum analysis no [1]

SCANNING ELECTRON MICROSCOPY (SEM)

Imaging by SEM / TEM ( without preparation, without report) analysis yes [2]

Identity test with SEM / TEM (without preparation, without report) analysis yes [2]

SEM microscopy, direct exposure (incl. short report and 2-4 images) analysis yes [2]

SEM, after embedding and sectioning (incl. short report and 2-4 images) analysis yes [2]

SEM/EDX, direct exposure (incl. short report and 2-4 images) analysis on request [2]

SEM/EDX, after embedding and sectioning (incl. 2-4 images and short report) analysis on request [2]

SEM after special sample preparation analysis no [2]

SEMI-QUANTITATIVE DETERMINATION BY EDX (ENERGY DISPERSIVE X-RAY ANALYSIS) / SEM

Semi quantitative elemental composition with EDX (homogeneous material, single determination, without preparation, without report)

analysis yes [1]

EDX, direct measurement, heterogeneous material (incl. short report and 2-4 images) analysis on request [1]

EDX after special sample preparation analysis on request [1]

TRANSMISSION ELECTRON MICROSCOPY (TEM)

TEM, negative staining (incl. short report and 2-4 images) analysis yes [1]

TEM, after embedding and sectioning (incl. short report and 2-4 images) analysis yes [1]

TEM after special sample preparation analysis yes [1]

PARTICLE SIZE DISTRIBUTION

Particle size distribution by light microscopy (single determination) analysis yes [1]

Particle size distribution by TEM/SEM (single determination) analysis yes [1]

PREPARATION OF SAMPLES

Simple preparation for microscopy (per sample) sample yes [1]

Preparation for microscopy (high, effort, per sample) sample yes [1]

REPORTING & SPECIAL SERVICES

Standard or customized report for microscopy analysis on request [1]

Feasibility Study, Method Development, Method Validation, Verification method on request [2]


Molecular Biology


Note

DNA sequencingSINGLE-PASS SEQUENCING

Plasmids, PCR products template no [2]

Plasmids, PCR products, 96 well Sequencing (minimum 48 samples) template no [2]

DOUBLE STRANDED SEQUENCING FOR CONFIRMATION

Design and synthesis of primers, raw data of all runs, sequence alignment, contig map, consensus sequence and report

order no [2]

Minimum charge per sequencing order order no [2]

Price per base base no [2]

SINGLE STRANDED SEQUENCING FOR CONFIRMATION

Design and synthesis of primers, raw data of all runs, sequence alignment, contig map, consensus sequence and report

order no [2]

Minimum charge per sequencing order order no [2]

Price per base base no [2]

PRIMER WALKING, NON-ASSEMBLED SINGLE STRANDED SEQUENCING

Complete sequencing of an insert on one DNA strand covered by non-assembled single reads

base no [2]

PRIMER WALKING, NON-ASSEMBLED DOUBLE STRANDED SEQUENCING

Complete sequencing of an insert on both DNA strand covered by non-assembled single reads

base no [2]

EXON SEQUENCING

Single nucleotide polymorphism (SNP) analysis amplicon no [2]

GMP SEQUENCING

Verification of product specific parameters for GMP sequencing - no [2]

GMP sequencing - no [2]

Full GMP sequencing report - no [2]

PRIMERS FOR DNA SEQUENCING

Standard primers (free of charge) - no [2]

Custom primer primer no [2]

Primer design (design, synthesis, HPLC purification) <max. 25 nucleotides>

primer no [2], [3]




Note

DNA PREPARATIONS

Plasmid miniprep on request sample no [2]

Plasmid miniprep (96 well plate) on request plate no [2]

PCR product purification on request sample no [2]

PCR product purification (96 well plate) on request plate no [2]

Maxiprep, endotoxin-free plasmid prep (500 micrograms guaranteed DNA amount; identity test by DNA sequencing, photometric quantification)

on request sample no [2]

TRANSFORMATION

E. coli transformation on request sample no [2]

Additional molecular biology servicesSITE-DIRECTED MUTAGENESIS

Site-directed mutagenesis <single site> on request one site no [2]

Site-directed mutagenesis <multiple sites>, mutagenesis per site includes exchange of closely adjacent positions within 10 base pairs

on request per site no [2]

> optional: sequence confirmation of positive clones on request kb no [2]

CLONES SCREENING BY SEQUENCING

Screening of at least 4 clones by sequencing with 2 primers of choice (i.e. end sequencing) and alignment to the indicated reference sequence; identification of positive clones; reporting

on request clone no [2]

> optional: sequence confirmation of positive clones on request kb no [2]

SUBCLONING (VIA PCR OR RESTRICTION ENZYME DIGESTION)

Subcloning of existing fragments into a vector of choice; including 1Kb sequence confirmation (single step cloning)


Subcloning of existing fragments into a vector of choice; including 1Kb sequence confirmation (multi step cloning)

on request step no [2]

> optional: confirmation sequencing of the cloned insert is highly recommended when a PCR step is required

on request kb no [2]

CLONING OF CDNA OR GENOMIC DNA

Isolation of genes or genomic regions of interest from cDNA or genomic DNA and cloning into a vector of choice


REPORTING

Comprehensive documentation, e.g. for subcloning report no [2]


Packaging Material and Medical Devices

Service/Parameter Handling of HIPO

Note

Controlled extractables and leachables studies (E&L)SAMPLE PREPARATION

Extraction of volatile and semi-volatile compounds(e.g. 60°C, Aqueous and/or organic solvents, placebo)

on request [2]

ANALYTICS

Generation of extraction profile by GC-MS (quantification of two highest concentrated semi-volatile compounds)

on request [2]

Subsequent GC-MS Headspace semiquantitative analysis of volatile compounds

on request [2]

Analysis of the highest compound concentrations of semi-volatile compounds (identification and semi-quantification)

on request [2]

Analysis of the highest compound concentrations of volatile compounds (identification and semi-quantification)

on request [2]

LC-MS/MS High Mass Accuracy (non-volatile compounds, identification and semi-quantification)

on request [2]

Anions of aqueous extract by ion chromatography on request [2]

Cations of aqueous extract by ICP-MS on request [2]

Reporting (study protocol, description of extraction methods, analytical parameters, interpretation, proposals for structure)

on request [2]

Container closure integrity test (CCIT)Method validation no [2], [4]

Routine measurements no [2], [4]

Layer thicknessMitutoyo digimatic on request [2]

Other related servicesReady-to-use components for primary and secondary packaging (container characterization, content determination, identification of contaminants)

on request [2]

Counterfeit drug and packaging identification on request [2]

Silicones in pharmaceutical applications on request [2]

Glass containers for pharmaceutical use according to EP 3.2.1 on request [2]

• Hydrolytic resistance of the inner surface (test A)

• Hydrolytic resistance of the glass grains (test B)

• Surface treatment (test C)


Particle Determination and Characterization



Note

Analysis of inhalation formulationsAERODYNAMIC PARTICLE SIZE DISTRIBUTION (APSD) BY CASCADE IMPACTION (E.G. NGI)

Fine particle mass (FPM), fine particle fraction (FPF), delivered dose, etc. on request sample no [2]

DELIVERED DOSE UNIFORMITY (DDU)

According to USP and Ph. Eur. on request sample no [2]

OTHER TESTS

Additional techniques and evaluations can be offered on request on request sample no [2]

Determination of particles: visible and subvisible VISIBLE PARTICLES ACC. TO PH. EUR. 2.9.20.

With or without sample preparation on request sample no [1]

SUBVISIBLE PARTICLES BY LIGHT OBSCURATION WITHOUT SAMPLE PREPARATION (≤ 100 ML) (PH.EUR. 2.9.19. / USP <788>/ <789>)

With or without sample preparation 25 mL sample no [1]

SUBVISIBLE PARTICLES BY LIGHT OBSCURATION WITHOUT SAMPLE PREPARATION (>100 ML) (PH. EUR. 2.9.19. / USP <788>/ <789>)

With or without sample preparation 25 mL sample no [1]

PARTICULATE MATTER BY MICROSCOPE (PH. EUR. 2.9.19. / USP <788>)

With or without sample preparation on request sample yes [2], [4]

SIZE DISTRIBUTION 1-50 µM WITHOUT SAMPLE PREPARATION

With or without sample preparation from 1 mL sample no [2]

Micro-flow imaging (MFI)Method development on request sample no [2]

Routine on request sample no [1]

Particle size determinationPARTICLE SIZE DISTRIBUTION BY LASER DIFFRACTION (MALVERN, SYMPATEC)

Feasibility study/ Method development (Dispersion and exp. Paramters, excl. SOP)

1 - 30 g product yes [2]

Method validation on request product yes [2]

Routine analysis

Wet dispersion in water 1 g analysis yes [1]

Wet dispersion in water saturated with active substance 1 g analysis yes [1]

Wet dispersion in organic medium 1 g analysis yes [1]

Wet dispersion in medium saturated with active substance 1 g analysis yes [1]

Dry dispersion 10 g analysis no [1]




Note

PARTICLE SIZE DISTRIBUTION: OTHER METHODS

Particle size distribution of API by light microscopy (semi-automized) on request analysis yes [1]

Particle size distribution of API by TEM/SEM (manual analysis) on request analysis yes [1]

Analytical sieving on request analysis no [1]


Pharmacopoeial Tests



Note

Assay by titration in aqueous and non-aqueous mediaSTANDARD METHOD

Per sample on request analysis yes [1]

MICRO-TITRIMETRIC METHOD

Titrimetric analyses acc. to Ph. Eur., USP, JP or other product specific methods

on request analysis yes [2]

DissolutionINTRINSIC DISSOLUTION (BUFFER SYSTEMS TO BE DEFINED) <PER BUFFER>

Per experiment / per buffer on request analysis no [2]

RECORDING OF DISSOLUTION PROFILES (WITHDRAWAL TIMES TO BE DEFINED; UP TO 3 H) ACC. TO CUSTOMER METHOD

Per experiment (n=6, ARGUS UV-measurement) on request analysis no [2]

DISSOLUTION RATE (INCL. HPLC) <PER EXPERIMENT>

Per experiment (stage 1, n=6) on request sample yes [2]

DISSOLUTION METHOD VALIDATION

Acc. to ICH guidelines (specificity, linearity, accuracy, filter check (recovery), precision, intermediate precision, stability of solutions)

on request product yes [2]

MorphologyDisintegration time on request product no [1]

Friability on request product no [1]

Crushing strength on request product no [1]

Residual solventsRESIDUAL SOLVENTS

Solvents by GC-HS (to be defined) 200 mg sample yes [2]

Water determination by Karl FischerVOLUMETRIC (TITRIMETRIC) MFETHOD

Product-specific verification (Ph. Eur. 2.5.12) 5 - 100 mg analysis yes [1]

Water determination by micro or semi-micro titration (direct or gas extraction method)

5 - 100 mg analysis yes [1]

Water determination in vials and ampoules (special method) 5 - 100 mg analysis yes [1]

Water determination in vials and ampoules (special method) including determination of filling weight


COULOMETRIC METHOD (OVEN METHOD / DIRECT METHOD)

Product-specific verification (Ph. Eur. 2.5.32) 5 - 100 mg analysis yes [1]

Per sample 5 - 100 mg analysis yes [1]



UnitHandling of HIPO

Note

Heavy metals, limit testsEUROPEAN PHARMACOPOEIA: HEAVY METALS ACC. TO PH. EUR. 2.4.8.

Methods A, B, C, D, E, F 2 - 4 g analysis yes [1]

UNITED STATES PHARMACOPOEIA: HEAVY METALS ACC. TO USP <231>

Methods I, II, III 2 - 4 g analysis yes [1]

JAPANESE PHARMACOPOEIA: HEAVY METALS ACC. TO JP 1.07

Method 1, 2, 3, 4 2 - 4 g analysis yes [1]

Pharmacopoeial testsANALYSES ACC. TO CURRENT PH. EUR. MONOGRAPHS

Mannitol “assay and related substances” acc. to Ph. Eur. 0559 on request sample no [2]

Ethylene oxide and Dioxane acc. to Ph. Eur. 2.4.25 min. 6.5 g sample no [2]

Ethanol anhydrous “volatile impurities” acc. to Ph. Eur. 1318 on request sample no [2]

Povidone “impurity A and impurity B” acc. to Ph. Eur. 0685 on request sample n/a [2]

Complete monograph testing acc. to Ph. Eur., USP-NF, JP, BP on request sample yes [2]

Ninhydrin positive substances acc. to Ph. Eur. 2.2.56 (method 1) on request sample yes [2]

PHARMACOPOEIA METHODS: GRAVIMETRIC ANALYSIS

Loss on drying / dry mass (Ph. Eur. 2.2.32., USP <731>) 1 g analysis yes [1]

Loss on drying / dry mass micro-method from 100 mg analysis yes [1]

Sulphated ash (Ph. Eur. 2.4.14., USP <281>) from 1 g analysis yes [1]

Sulphated ash micro-method from 100 mg analysis yes [1]

Total ash / Loss on ignition (Ph. Eur. 2.4.16., USP <733>) from 100 mg analysis yes [1]

Residue on ignition from 100 mg analysis yes [1]


Physico-Chemical Parameters and Solid State Properties



Note

Analysis of solid state propertiesDYNAMIC VAPOR SORPTION (DVS)

1, 2 or multiple cycles, continues or stepwise measurement 20 mg analysis yes [2]

MELTING POINT DETERMINATION

Melting point (capillary, instrumental) 10 mg analysis no [1]

Melting point (DSC method) 10 mg analysis yes [1]

THERMAL METHODS

Differential Scanning Calorimetry (DSC) 6 - 10 mg analysis yes [1]

Isothermal calorimetry (TAM), micro calorimetry on request analysis yes [1]

Solution calorimetry 100 mg analysis yes [1]

Thermogravimetry (TG) 10 mg analysis yes [1]

Thermogravimetry coupled to FTIR (TG-FTIR) 10 mg analysis yes [1]

X-RAY POWDER DIFFRACTION (XRPD)

XRPD measurement with electronic data submission only (without interpretation/report)


XRPD measurement with electronic data submission, including short interpretation and short report


Diffraction by TEM on request analysis no [1]

VARIOUS SOLID STATE PARAMETERS

Specific surface (BET) on request analysis no [1]

Tapped density, tapped volume 200 mL analysis no [1]

Bulk density, bulk volume 200 mL analysis no [1]

DissolutionINTRINSIC DISSOLUTION (BUFFER SYSTEMS TO BE DEFINED)

Experiment <per buffer> (see chapter Pharmacopoeial Tests) on request analysis no [2]

RECORDING OF DISSOLUTION PROFILES (WITHDRAWAL TIMES TO BE DEFINED; UP TO 3 H)

Experiment (n=6, ARGUS UV-measurement, acc. to customer method) (see chapter Pharmacopoeial Tests)

on request sample no [2]

pKa determinationPHOTOMETRIC OR POTENTIOMETRIC TITRATION OF PKA VALUES (SIRIUS T3)

pKa values between 2 and 13 with aqueous solubility(>50 µM photometric or >1.5 mM potentiometric)

5 - 10 mg sample yes [2]

pKa values between 2 and 13 with aqueous solubility(<50 µM photometric or >1.5 mM potentiometric)

5 - 10 mg sample yes [2]

pKa determination with use of co-solvent 5 - 10 mg sample yes [2]




Note

Partition coefficient (logP) and distribution coefficient (logD)OECD GUIDELINE 107 (SHAKE FLASK METHOD, HPLC-UV, LOGP/LOGD VALUES BETWEEN -2 AND 4)

Price per determination 50 - 100 mg analysis yes [2]

Other detectors on request analysis yes [2]

OECD GUIDELINE 117 (HPLC-UV METHOD FOR UNCHARGED MOLECULES, PH RANGE 1 TO 9, LOGP VALUES BETWEEN 0 AND 6)

Price per determination 50 mg analysis yes [2]

Other detectors on request analysis yes [2]

OECD DRAFT GUIDELINE 122 (FOR LOGP/LOGD BY PH METRIC METHOD, VALUES BETWEEN -2 AND 7 (FOR IONIZABLE COMPOUNDS ONLY) INCL. PKA)

Price per determination 5 - 10 mg analysis yes [2]

Solubility testingAPPROXIMATE SOLUBILITY IN ORGANIC SOLVENTS ACC. TO PH. EUR. CHAPTER 5.11 (TEMPERATURE RANGE 5°C TO 80°C)


EXACT SOLUBILITY IN BUFFER SOLUTIONS (HPLC: 24 H AT 25°C OR 37°C)

Single determination 20 - 110 mg analysis yes [2]

Duplicate determination 40 - 220 mg analysis yes [2]

Analysis of solubility residue by XRPD - sample yes [2]

pH determination Standard method according to USP or Ph. Eur. on request analysis yes [1]

Potentiometric method on request analysis yes [1]

Sample preparation on request analysis yes [1]

Various physico-chemical parametersDensity of liquids 10 mL analysis yes [1]

Osmolality (by freezing point depression) 0.5 mL analysis yes [1]

Refractive index 1 mL analysis yes [1]

Specific surface (BET) 5 g analysis no [1]

Surface tension (ring or plate method) 20 mL analysis yes [1]

Viscosity (with or without sample preparation) 10 mL analysis yes [1]

Rheological studies (e.g. viscoelastic properties, etc.) ≥ 0.5 mL study yes [2]

Turbidimetry on request analysis no [2]

Conductivity: direct measurement with or without sample preparation on request analysis yes [1]


Proteins and Peptides: Analysis of Biopharmaceuticals

Characterization and Assay (according ICH Q6B)Analytical services for biopharmaceuticals require a customized approach. Please get in touch and request a proposal for our services in the field, which are outlined below.

PHYSICOCHEMICAL PROPERTIES

Appearance, pH, Turbidity Electrophoretic and chromatographic patterns

Molecular weight Extincintion coefficient

Isoform pattern Spectroscopic profiles

Isoelectric point

STRUCTURAL CHARACTERIZATION

Amino acid composition Peptide mapping

C- / N-Terminal amino acid determination Post-translational modifications

Carbohydrate structure Sulfhydryl groups and disulfide bridges

IMPURITIES

Aggregation

Degradation

Host cell DNA / proteins

Oxidation/ Desamidation

Process related impurities (e.g. insulin, serum proteins, IPTG, antibiotics, Protein A, TFA, Tween 20, Tween 80, TCEP, DTT, solvents, heavy metals)

ASSAY

Amino acid analysis

Immunoassay

Protein assay

Stability testingSTABILITY STUDY SERVICES (ACCORDING ICH Q1A/Q1B/Q5C)

Long-term and short-term stability studies, including storage of samples

Forced degradation and Photostability studies

Glycoproteins analysisN-glycosylation / O-glycosylation

Heterogeneity of protein glycosylation, e.g. occupancy, type of glycosylation, oligosaccharide structure

Monosaccharide analysis

Peptide mappingIdentity

Primary sequence

Disulphide bonds

Product-related impurities (e.g. oxidation, desamidation)

Chemical modifications (e.g. PEGylation)


Method portfolioCHROMATOGRAPHY (DETECTION MODES: UV, DAD, FLD, ELSD, ECD, MALLS, DLS, RI, PAD, ESI, APCI)

Affinity chromatography Normal phase chromatography

Asymmetric-Flow Field-Flow Fractionation Reversed phase chromatography

Hydrophilic interaction chromatography Size exclusion chromatography

Ion exchange chromatography

SPECTROSCOPY AND SPECTROMETRY

CD spectroscopy (far UV, near UV) FTIR spectroscopy

Determination of extinction coefficient by UV (280 nm) MALDI TOF or MS-ESI (accurate mass elucidation)

DLS dynamic light scattering NMR (structure confirmation up to 2000 Da)

nano-DSC differential scanning calorimetry Raman and UV/VIS spectroscopy

Fluorescence spectroscopy

GEL ELECTROPHORESIS (VARIOUS STAINING METHODS, E.G. COOMASSIE, SILVER, WESTERN)

2D PAGE

Agarose gelelectrophoresis

Isoelectric focusing

Native PAGE

SDS-PAGE (with coomassie brilliant blue, silver staining, western blotting)

CAPILLARY ELECTROPHORESIS

Capillary gel electrophoresis

Capillary isoelectric focusing

Capillary zone electrophoresis

AMINO ACID ANALYSIS

Amino acid content / composition

Identity, foreign amino acids

FURTHER TECHNIQUES

Analytical ultracentrifugation (AUC) Fractionation of impurities (MS)

Bacterial endotoxins Immunoassays (ELISA, Dot blot)

Container closure integrity test Microbial enumeration test

Determination of visible and subvisible particles Sterility testing


Spectroscopy and Structure Elucidation



Note

Mass spectrometry and structure elucidationStructure confirmation/elucidation, exact mass etc. on request sample no [2]

NMR spectroscopy1D-NMR SPECTRUM

1H, 19F, 31P or 13C incl. simple interpretation (structure confirmation) 10 mg sample yes [2], [3]

2D-NMR SPECTRA: HSQC, HMBC, COSY, NOESY

Spectrum, incl. simple interpretation (structure confirmation) 10 - 50 mg sample yes [2], [3]

STRUCTURE EVALUATION

Detailed evaluation of spectra (1D and 2D) or structure confirmation on request sample no [2], [3]

QUANTITATIVE NMR

Assay, duplicate determination with internal standards 10 - 30 mg analysis yes [2], [3]

Impurities with existing methods on request analysis yes [2], [3]

Feasibility study: typically recording of 3 spectra of different dilutions and solvents

on request analysis yes [2], [3]

Method development (typical effort after feasibility) on request analysis yes [2], [3]

Interpretation and report on request analysis yes [2], [3]

SURCHARGES FOR NMR

Surcharge per spectrum for long-term NMR experiments < 10 mg analysis yes [2], [3]

SpectroscopyCIRCULAR DICHROISM (CD), OPTICAL ROTATORY DISPERSION (ORD)

CD spectrum (up to 2 measuring ranges), ORD spectrum on request analysis yes [2]

Secondary structure analysis, CD melting curve on request analysis no [2]

POLARIMETRY

Polarimetry (one wavelength, one solvent) 100 mg analysis yes [1]

INFRARED AND RAMAN

FT-IR with or without interpretation by Nujol 10 mg analysis yes [1]

FT-IR with or without interpretation with ATR probe by KBr pellet 10 mg analysis no [1]

IR microscopic testing, per spectrum 10 mg analysis no [1]

Raman spectrum, no interpretation 10 mg analysis yes [1]

UV/VIS

Simple sample preparation, good soluble samples on request analysis yes [1]

FLUORESCENCE SPECTROSCOPY

Simple sample preparation, good soluble samples on request analysis yes [1]


Stability Studies and Release Testing



Note

Stability studiesPHOTOSTABILITY ACC. TO ICH Q1B

Irradiation and assessment of appearance, excl. any further analysis:

Confirmatory study: Irradiation up to 2.4 MLuxh on request analysis on request [1]

Forced Degradation: Irradiation up to 6 MLuxh on request analysis on request [1]

Special irradiation experiments on request analysis on request [2]

STABILITY STUDIES

Accelerated stability studies on request analysis no [2]

Comparative stability testing on request analysis no [2]

Compatibility studies on request analysis no [2]

Freeze/ Thaw studies on request analysis no [2]

Forced degradation studies / stress testing on request analysis no [2]

In-use studies on request analysis no [2]

Intermediate stability studies on request analysis no [2]

Long-term stability studies on request analysis no [2]

Temperature cycle testing on request analysis no [2]

Storage of stability samples SHORT-TERM AND/OR LONG-TERM STABILITY STUDIES

The following storage conditions are available:

-80°C, -20°C, 5°C, 25°C/60% rh, 30°C/65% rh, 30°C/75% rh, 40°C/75% rh, 50°C, 60°C

on request - on request [2]

Other storage conditions on request - on request [2]

Release testingQuality Control acc. to ISO and GMP for various galenical forms:

Raw materials and excipients, API starting materials, intermediates, drug substances, drug products, containers (glass, vials, syringes, plastics etc), enzymes, NGIs

on request - on request [2]


A Abnormal toxicity 11

Acute dermal irritation 11

Amino acid analysis (AAA) 22, 23

Analytical sieving 17

Analytical ultracentrifugation (AUC) 23

Antibiotics - microbial assay 10

Assays - cell based & biological 11

Asymmetric-Flow Field-Flow Fractionation 23

Atomic absorption spectrometry (FAAS, ETAAS, CVAAS) 6

Atomic emission spectrometry (ICP-AES, ICP-OES) 5, 6, 8

B Bacterial endotoxins test acc. to Pharm. Eur. 9, 23

Bacterial spores suspension 10

Bioburden 9, 11

Biological assays 11, 23

Bulk density/volume 20

C Calorimetry 20

Capillary electrophoresis (CE) 4, 23

Cell based bioassays 11

Chiral separation techniques (CE, HPLC, GC, SFC) 3, 4, 23

Chromatography 3, 4

Chromogenic kinetic method 10

Circular dichroism (CD) 23, 21

Clean processes (room, water, gas) 10

Cleaning validation 4, 10, 11

Cloning/Subcloning services 14

Combustion analysis (C, H, N, O, S, halogens) 5

Combustion analysis (inorganic ash, residue on combustion) 5, 19

Compatibility studies 25

Conductivity measurements 21

Container closure integrity test 10, 15, 23

Controlled extraction studies 15

Counterfeit drug and packaging identification 15

Crushing strength 18

Cryoconservation of microorganisms 10

Cytotoxicity 11

D D-value 10

Density measurements (fluids) 20

Differential scanning calorimetry (DSC) 20

Diffraction by TEM 20

Disinfectant efficacy study 10

Disintegration time 18

Dissolution testing (manual and autosampling) 18, 20

Distribution coefficient (logD) 21

DNA preparation 14

DNA sequencing 13

Dye test 10

Dynamic vapor sorption (DVS) 20

E EDX (energy dispersive X-ray analysis) 12

Electron microscopy (SEM, TEM) 12

Electrophoresis (capillary or gel) 4, 23

Elemental analysis 5

ELISA 23

Endotoxin determination 9, 23

Extractables & leachables study (E&L) 15

F Flame-AAS, FAAS 21

Fluorescence spectroscopy 21

Flow cytometry 11

Fourier transform infrared spectroscopy (FTIR) 21

Freeze / thaw study 25

Friability 18

G Gas chromatography 3

Gel clot method 10

Gel electrophoresis 4

Glass container testing 15

Glycoprotein analysis 22

Gravimetric analysis (e.g. loss on drying, total ash, loss on ignition, residue on ignition)

7, 19

Growth promotion test 10

H Halogen, halogenide determinations 5

Headspace gas chromatography 3

Heavy metal determination acc. to Ph. Eur., JP, USP 7, 19

Heavy metal screening (ICP-OES, ICP-MS) 7, 8

Hemolysis / Hemocompatability 11

High Pressure Liquid Chromatography (HPLC, UPLC) 3

Host cell proteins (HCP) 11

Hot stage raman microscopy 12

HPLC (High Pressure Liquid Chromatography) 3

Hyaluronic acid gel 11

I Immunoassays (ELISA, Dot blot) 23

ICP-AES / ICP-OES 5, 6, 8

ICP-MS 6, 7, 8

In-use study 25

Infrared microscopy (IR microscopy) 12

Inhalation formulation analysis 16

Inhaler testing (NGI) 16

Inorganic elemental mass spectrometry (ICP-MS) 6, 7, 8

Ion chromatography (IC) 3

Ions (semiquantitative screening) 3

Isoelectric focussing (capillary or gel electrophoresis) 4, 23

K Karl Fischer water determination 18

Kjeldahl nitrogen determination 5

L LAL testing (endotoxins) 9, 23

Leachables studies 15

Lidocaine 11

Liquid chromatography 3

Low endotoxin recovery (LER) study 9, 10

Lymphoma 11

M Malvern (particle sizing) 16

Mass spectrometry (GC-MS) 3

Mass spectrometry (ICP-MS) 6, 7, 8

Mass spectrometry (LC-MS/MS, MALDI-TOF/TOF) 10, 23

Media fill test 10

Medical devices 11

Micro flow imaging (MFI) 16

Microbial assay 9, 10

Microbial assay of antibiotics 10

Microbial enumeration test 9

Microbial igress test (MIT) 10

Microbiological tests of non-sterile products 9, 23

Microbiological tests of sterile products 9, 23

Microorganisms specified 9

Microscopy (light microscopy, SEM, TEM, EDX, Raman) 12

Minimum inhibitory concentration 9

Monocyte Activation Test (MAT) 10

Morphology 18

Mycoplasma detection 9

N Native PAGE 4

Next generation impactors (NGI) 16, 25

Nitrogen determination according to Kjeldahl 5

Nitrosamines 4

Nuclear magnetic resonance spectroscopy (NMR) 24

O Occupational hygiene analysis 15

Optical emission spectrometry (ICP-OES) 5, 8

Optical rotatory dispersion (ORD) 24

P Particle determination & characterization 16

Particle size distribution by laser diffraction (Malvern, Sympatec) 16

Particle size distribution by microscopy 12

Particulate matter 9, 16, 23

Partition coefficient (logP) 21

Peptide mapping 22

pH determination 21

Pharmacopeial methods 18, 19

Photostability 25

Physico-chemical parameters (e.g. density, viscosity, log P, pKa, solubility)

20, 21

Polarimetry 24

Preservative efficacy test 9

Proteins & peptides 22, 23

Pyrogens 9, 11

Index


Q Quality Control 25

Quantitative elemental determinations (FAAS/ETAAS/CVAAS, ICP-OES/MS, XRF)

5, 6, 7, 8

R Raman microscopy 12

Ready-to-use components 15

Recombinant factor C 10

Release testing 25

Residual hydrocarbons 11

Residual solvents 3, 18

Rheology 21

S Scanning electron microscopy (SEM) with energy dispersive X-ray analysis (EDX)

12

SDS-PAGE 4

Semiquantitative screening of ions (cation and anion packages) 3

Separation techniques 3, 4

Sequencing: GMP-sequencing 13

Silicones in pharmaceutical applications 15

Single radial immuno diffusion (SRID) 11

Site-Directed Mutagenesis 14

Size exclusion chromatography (SEC) 23

Sodium hyaluronate 11

Solid state properties 20

Solubility testing 21

Specific surface area (BET) 21

Spectroscopy (IR, Raman, NMR, fluorescence, phosphorescence, UV/VIS, CD)

23, 24

Stability studies 22, 25

Sterility test 9, 11

Storage of stability samples 22, 25

Stress testing 25

Subvisible particles 9, 16, 23

Surface tension (plate and ring methods) 21

T Tapped density / volume 20

Thermogravimetry (TG, TG-FTIR) 20

Thin layer chromatography (TLC) 4

ThresholdTM 22, 23

Titration 5, 18, 20

Total nitrogen (TN) 5

Total organic carbon (TOC) 5

Transmission electron microscopy (TEM) 12

Turbidimetric kinetic method 10

Tween analysis 4

U Ultracentrifuge, analytical (AUC) 23

UV/VIS spectroscopy 24

V Vapor sorption measurements (DVS) 20

Viscosity (capillary and rheometer) 21

Visible and subvisible particles 16

Voltammetry 7

W Water (pharmaceutical) 10

Water activity 9

Water determination by Karl Fischer 18

Western blotting 23

X X-ray fluorescence (XRF) 6, 8

X-ray powder diffraction (XRPD) 20

catalogue analytical services - solvias...page 1 february 2020 catalogue analytical services general...

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