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Extractables & Leachables

West Analytical Services is your source for extractables/leachables testing for all pharmaceutical products

To expedite the process and 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.

  • Extraction studies and identification of extractables (GC/MS, LC/MS, LC/MS/MS, ICP/MS, IC)
  • Migration testing – labels and printing on pouches, bags and semi-permeable containers
  • West E2L™ Testing – A risk assessment service to help determine which analytes should be considered for leachables method development. With West E2L, you may not have to expend valuable resources testing leachables that may be considered low-risk for your drug product.
  • Material extraction control (DPI, MDI, nasal sprays, other devices and materials)
  • Extractable profiles for packaging
  • Leachables testing in drug product over shelf life
  • Toxicological evaluations for extractables and leachables
Additionally more information on the Verisure Technical Package
is available.

Please click here to contact us by email to discuss your needs for extractables and leachables testing.

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
  • 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 to discuss your needs for method development and validation.