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Extractables and Leachables Testing in the Pharmaceutical Industry

Leachables are organic or inorganic compounds that migrate into the drug product formulation from the container closure system as result of direct contact with the formulation. They are typically low‐molecular weight volatile compounds that migrate through semi‐permeable containers. Leachables testing is required for monitoring and controlling container closure‐ derived impurities in the drug product during stability and/or to qualify container closures for use. Potential sources of leachables include the container fabrication components, migrants from labeling or secondary packaging, and reaction products between the formulation and the container closure system. Leachables can present difficult analytical challenges, as they are frequently present at levels that are orders of magnitude lower than drug degradation products or related substances, well below the sensitivity of the Drug Product testing methods. Therefore, separate analytical methods are usually needed for leachable analysis on the drug product containers.

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