Analytical & Quality Control
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Home | Services & Solutions | Analytical
With over 3,500 analytical scientists at our development and manufacturing sites across the world, we provide a full suite of analytical services to support projects from discovery to pre-clinical and clinical development, all the way through to commercial manufacturing for both drug substance and drug product programs.
Our teams provide a full spectrum of analytical method development, validation and testing services, including all general and unique testing required to support your small molecule new drug development. We support all synthetic molecules, including high potency compounds with an Occupational Exposure Limit (OEL) of 10 ng/m³.
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Analytical Services
- Drug substance and drug product analytical method development and validation
- Drug substance and drug product release testing ICH stability studies
- Reference standard characterization and qualification
- Potential Genotoxic Impurities (PGI) method development, validation, and testing
- Impurity / degradant isolation and structure elucidation
- Highly potent compound analysis
- Packaging system evaluation, including Container-Closure Integrity Testing (CCIT)
Sterility testing and species identification
Track Record：
- 12,000+ chromatographic and 2,000+ non-chromatographic methods developed in 2023
- 500+ structure characterization for IND/NDA fillings in 2023
Special ability for nitrosamine analytical method development and testing:
- 20+ nitrosamine analytical methods developed and validated
- 330+ samples analyses
- Generic method with 10 ppb LOQ by UPLC/MS/MS for common nitrosamines (NDMA, NMBA, NDEA, NEIPA, NDIPA, NMPA, NDBA, etc), complying with FDA/EMA/NMPA requirements
- Specific methods for Nitrosamine Drug Substance-Related Impurities (NDSRIs)
Quality Control
- Method validation (IND/NDA, commercial)
- Full release testing (raw materials, reagents, drug substance and drug product)
- ICH stability study
Track Record:
- 10,000+ drug substance and 1,000+ drug product batches released annually
- Successfully passed 50+ Pre-Approval Inspections (PAIs) from global regulatory agencies
Key Equipment
- Chromatography: UPLC, HPLC, Nano HPLC, GC, IC, SEC, SFC
- Mass Spectrometry: QTOF, MALDI-TOF, LC-Orbitrap, LC-MS, 2D LC-MS, GC-MS
- Solid State Characterization: XRPD, DVS, DSC, TGA with MS interface, PSD, nano-particle size analyzer, polarized light microscope, SEM, surface area analyzer
- Identification: NMR, HRMS, FT-IR
- Elemental Analysis: ICP-OES, ICP-MS
Drug Product Analytical Teams
Unique capabilities:
- End to end analytical development for both oral and parenteral drugs with various of dosage forms and filling formats
- Genotoxic impurity evaluation and testing platform with 1,500+ GTI database and 2,000+ method database
- High potency drug product analysis for both oral and injectable dosage forms
Track Record:
- 2,000+ clinical projects including 40+ late phase projects
- Successfully submitted 500+ IND dossier files and 35+ NDA/ANDA dossier files
Drug Product Quality Control Teams
Capabilities and Track Record:
- 1,000+ batches released annually, 3,000+ ongoing stability batches
- Digital systems LIMS & ELN & Trackwise & Veeva & Empower
- Dedicated high potency QC laboratories
- Successfully passed all inspections from various regulatory agencies including FDA, NMPA, PMDA and EMA.
