Kymos Group 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.
Analytical Techniques for Extractables & Leachables
We have developed the following methodology to analyze extraction solutions by LC/MS, GC/MS, LC/UV:
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