Extractables and Leachables – Must We?

Leachables are chemical species that migrate from packaging or other components into the drug product under normal conditions. Request for the leachables data is typically raised on dossier submission and/or during audits.

Currently, the data necessary to identify and qualify leachables does not seem to be enforced consistently , but we are observing an increasing trend in the request for leachables data. The data to be submitted is recommended in guidance documents and USP recent chapters, but there are no common specifications for leachables as this is drug specific.

General lab screening methods for leachables may provide qualitative results only and cannot always detect what is selected or seen on a potential extractables list due to drug product interference. Hence, test methods should be developed and validated to deliver both qualitative and quantitative results specific to a drug product.

West is happy to discuss options and offerings available in support of drug manufacturers for extractables and leachables data. Please feel free to contact your Technical Customer Support representative for more information.