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Method Development / Validation

To expedite the process and allow the client to focus its resources on other project aspects, clients turn to West Analytical Services for method development. Using our analytical expertise and state-of-the-art instrumentation, we are fully qualified to develop analytical methods to meet client needs. Methods can be developed in support of packaging (compatibility and functionality), extractables/leachables, quality control, in-process and process validation.

Validation of analytical methods must be completed to determine performance characteristics for the intended analytical application. Depending on performance characteristics, validation parameters may change.

In general, West Analytical Services follows ICH, FDA and USP guidelines for methods validation for:

  • Nasal, pulmonary, injectable, and oral liquid drug products
  • Active pharmaceutical ingredients, intermediates
  • Chromatographic Techniques: HPLC/DAD/ELS/RI, GC/MS, LC/MS, High-resolution LC/MS/MS, IC/EC
  • Techniques: Viscosity, Osmometry, Surface Tension, TGA, DSC, Microscopy, Karl Fisher, Wet Chemical
  • Identification: FTIR, MS, UV, TLC
  • Residual solvents (GC, GC/MS, Headspace)
  • Metals (AA, ICP/OES, ICP/MS)
  • Trace organics - cleaning residues (TOC), leachables, extractables
  • Forced degradation studies
  • ICH guidelines

Please click here to contact us by email to discuss your needs for method development and validation.