Organic assay and impurity testing
At our UK MHRA cGMP compliance facilities, our scientists combine a wealth of technical expertise with extensive knowledge of industrial and regulatory requirements to support both routine and tailored analytical testing of a broad spectrum of compounds and dosage forms to your specific needs.
Contamination and impurity identification is critical to the safety, efficacy and quality of a pharmaceutical of consumer healthcare product and is a regulatory requirement.
We have a long-standing history in the development and validation of bespoke analytical methods for impurity monitoring in the pharmaceutical and healthcare sectors.
Our experience includes supporting a wide range of products at the discovery, development and manufacturing stage.
Latest state-of-the art analytical equipment, we continually work with instrument manufacturers to push the boundaries of separation sciences.
- HPLC and UPLC with PDA, MS, UV
- GC and Headspace GC with FID, ECD, MS (Agilent 7890B GC with Agilent 5977 MSD)
- High resolution LC-MS
- Waters Acquity H-Class (PDA) with Waters Synapt G2 Q-TOF MS (with Ion Mobility Separation)
- Waters Acquity H-Class (PDA) with Waters Xevo G2 XS MS
- Supercritical fluid chromatography (SFC) with PDA, MS
- Optical Rotation
- Karl Fisher
- ID, potency and purity testing of drug substance and drug product
- Raw material, excipient and active substance testing
- Materials testing to USP, EP, BP and JP compendial monographs
- Full release and in-process testing
- Phase appropriate method development, optimisation, qualification, validation and transfer
- Impurity profiles and specification limit development including N-nitrosodimethylamine (NDMA) analysis
- Genotoxin method development and testing
- Solubility and dissolution studies
- Excipient compatibility tests
- Content and blend uniformity
- Residual solvents and water content analysis
- Stability Testing
- Protocol design
- Accelerated and long-term stability testing
- Drug substance stability testing
- Finished drug product stability testing (solid oral dose, inhaled and nasal, parenteral, topical/creams)
- Comparator testing and bioequivalence studies
- Photostability (ICH Q1B)
- Temperature cycling studies