Method Development and ValidationSource: West Analytical Services
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 for stability indicating analysis of drug products, packaging (compatibility and functional), 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.
- 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