Organic assay & impurity testing

Capabilities

Not only do Drug Development Solutions have access to the latest state-of-the art analytical equipment, we continually work with instrument manufacturers to push the boundaries of separation sciences. 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.

Techniques

  • 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