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Extractables and Leachables Analysis

Industry leading knowledge and expertise

West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.

Analysis includes: 

  • 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™– A risk assessment service to help determine which analytics 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 and quality control profiles (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

Leachables analysis for parenteral, nasal, pulmonary and oral liquid/subligual drug products includes:

  • 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

In general, West follows ICH, FDA and USP guidelines for methods validation for leachables analysis.







E2L is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.