Compendial Monograph and Pharmacopeial Testing

We deliver a comprehensive range of testing services aligned with global pharmacopeia requirements. Our capabilities include full monograph testing, physicochemical analysis, stability studies, and advanced analytical services. We specialize in method validation, verification, and development of stability-indicating assays that support your product development and manufacturing needs. 

• Full monograph testing across major pharmacopeias 

• Physicochemical testing including specific gravity and dissolution studies 

• Comprehensive stability studies and container-closure qualifications 

• Metals and elemental impurities analysis 

• Complete microbiological testing programs 

Our testing capabilities span the complete pharmaceutical spectrum, from raw materials and APIs to excipients, intermediates, starting materials, and finished products. We support both small and large molecule products through comprehensive testing programs that meet global regulatory requirements. Our expertise extends to cell banks, vectors, bulk harvest materials, and control cells for biological products.

Our solutions encompass the full scope of pharmaceutical testing requirements, from initial method validation through stability studies and release testing. We provide method validation and verification services compliant with USP <1255> and <1226>, stability-indicating assay development, and ICH stability studies for APIs and finished products. Our programs serve as ideal specifications for USP/NF, EP, BP, and JP requirements, delivering the documentation you need for manufacturing release. Our comprehensive approach includes container-closure qualifications and complete microbiological testing programs. 

Compendial test methods and applications: 

• Full monograph testing (USP/NF, EP, JP, BP) 

• Compendial method validation (USP <1255>) 

• Compendial method verification 

• Raw material testing (USP/NF, EP, JP, BP) 

• ICH stability studies (API and finished products) 

• Stability indicating assay and related substances methods 

• Physicochemical testing 

• Specific gravity (USP <841>) 

• Injectables (USP <1>) 

• Loss on Drying (USP <731>) 

• Stability studies (ICH Q1A-E) 

• Dissolution studies (USP <711>) 

• Particle size distribution determination 

• Methods verification (USP <1226>) 

• General identification tests (USP <191>) 

• Identification and quantitation (USP <621>) 

• Spectrophotometric analyses (USP <197>) 

• Metals and elemental impurities (USP <232, 233>, ICH Q3D) 

• Impurities and residual solvents (USP <467>) 

• Melting range or temperature 

• Uniformity of dosage (USP <791>) 

• Container-closure qualifications 

• Microbiological testing 

Large molecule compendial and pharmacopeial testing services: 

• Bioanalytical guidance ICH M10 (Draft) and FDA Bioanalytical Method Validation Guidance for Industry 

• FDA Guidance for Industry Potency Tests for Cellular and Gene Therapy Products 

• Adventitious agent viral QPCR (USP <1126, 1127>, EP 2.6.7) 

• QPCR assays (USP <12269, 1227>, EP 2.6.21) 

• Osmolarity, pH, DLS (USP, EP) 

• Impurities in Drug Substances and Drug Product (USP <1086>) 

• In vitro bioassay determination of biopotency 

• In vitro biological reactivity tests 

• Pyrogen test 

• Acute toxicity 

• Cytotoxicity (USP <87>) 

• Ancillary (USP <1043>) 

• Mycoplasma detection assays (USP <63>, EP 2.6.7, JP) 

• Mycoplasma clearance studies 

• Physical compendial testing (USP, EP) 

• Quantitative purity and impurity analyses 

• Process impurities (USP <467>, USP <232, 233>, ICH Q3D) 

Compendial microbiology services: 

• Bacterial endotoxins (LAL) tests 

• LAL validation (inhibition and enhancement test) 

• Microbial limits test (MLT) 

• Microbial enumeration test (MET) 

• Total aerobic microbial count (TAMC) 

• Total combined yeasts and molds count (TYMC) 

• Specified microorganism tests 

• Antimicrobial effectiveness test (AET) 

• Monocyte-activation test 

• Bioburden (USP <61>) 

• Sterility (USP <71>, EP 2.6.1, EP 2.6.12) 

• Endotoxin (USP <85>, EP 2.6.12) 

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Our experts provide support throughout your testing program, offering insights into global pharmacopeias and extensive experience with diverse pharmaceutical products. We maintain an "always available" approach to expedite your testing needs while meeting all quality requirements for manufacturing release.