Aragen has developed extensive methodologies for designing studies to identify extractables and leachables in drug products. We conduct extractable studies for almost all primary packaging materials, and leachable studies for parenteral and IV drug products. Volatile, semi-volatile, non-volatile compounds and elemental impurities are measured using different analytical techniques.
A dedicated team undertakes these studies and experts interpret the data generated from different analytical instruments, including LC-MS/MS, ICP-MS and GC-MS. We have a proven track record of successful submissions of protocols and reports to global regulators.
Aligning EHS and sustainability initiatives with strategic business value.
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