Extractables & Leachables

Kymos provides GMP-certified extractables & leachables testing services in accordance with relevant pharmacopoeia and in combination with other CMC assays. These extractables & leachables tests target pharmaceutical manufacturers in need of determining the profile of extractables and leachables in pharmaceutical packaging system components that are in contact with the formulation during storage and/or use in order to ensure product quality and patient safety. We take advantage of our state-of-the-art pool of instruments and analytical know-how to follow a case-by-case approach for each manufacturing setup and determine the most adequate safety thresholds, extraction and analysis techniques. Our expert team can provide you with the following extractables and leachables test services:

• Reflux
• Soxhlet
• Sonication

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 LC/HRMS Orbitrap detector, HPLC/UPLC MS (electrospray and atmospheric pressure chemical ionization) and LC/UV-vis
  • Specific compound workflow identification by means of LC-HRMS analysis and Compound Discoverer software