Organic assay and impurity testing

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.

Our facilities have been inspected by the UK MHRA for cGMP compliance.

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.

Techniques

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
  • TLC
  • Dissolution
  • Optical Rotation
  • Titration
  • pH
  • Conductivity
  • Karl Fisher

 

Applications

  • 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