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:

GC-MS Agilent 7890 laboratory

Extraction Techniques for Extractables & Leachables

  • Reflux
  • Soxhlet
  • Sonication

ANALYTICAL Techniques for Extractables & Leachables

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
extractables and leachables
Extractables and Leachables GC-MS Agilent 7890

Related Services to Extractables & Leachables

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

Microbiology

Laboratory including cleanroom with airlock technology and HEPA filters for testing of sterile and non-sterile APIs and drug products.

ELEMENTAL, NITROSAMINES  OTHER IMPURITY TESTING

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vacines and other biologics.

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EU Sites

Kymos Group

Barcelona
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Frankfurt
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Ancona
Italy

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Paris
France

Basel
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Milano
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