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Brochures: Extractables & leachables services

Posted: 19 February 2020 | | No comments yet

Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.

Regulatory bodies such as the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) are increasingly focusing on the interactions between various manufacturing components (such as single use systems), drug delivery devices and container-closure systems, and the finished pharmaceutical product.

The FDA has stated in its packaging guideline from 1999 that “Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” Consequently, extractables and leachables (E&L) studies are crucial component of product release.











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