Extractables & Leachables

In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. A study should be conducted to determine the extractables profile from the container closure components that are in contact with the formulation during storage and/or use. For compounds that appear as leachables present in the formulation at the end of the shelf life of the product or sooner, identification should be attempted and safety assessments should be conducted in accordance with adequately established safety thresholds

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Extraction Techniques:

  • Reflux
  • Soxhlet
  • Sonication

Analysis Techniques:

We have developed the following methodology to analyze extraction solutions by LC/MS, GC/MS, LC/UV:

  • Semi-quantitative screening for both volatile and semi-volatile organic compounds:
    • Use of GC/MS instrumentation with direct injection sample introduction and electron impact ionization
    • Use of GC/MS instrumentation with headspace sample introduction and electron impact ionization
    • For extractables compounds detected by GC/MS analysis, we utilize NIST2011 database to assist in identification
  • Semi-quantitative screening for non-volatile organic compounds:
    • Analysis using HPLC/UPLC MS (electrospray and atmospheric pressure chemical ionization) and LC/UV/Vis.

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