A Robust Extractables Data Package Helps Drive Patient Safety

By Will Parker, Manager, Extractables & Leachables

The scrutiny of extractables and leachables (E&L) from pharmaceutical packaging and delivery systems has intensified significantly since its inception in the mid-1990s. Regulatory agencies have become more knowledgeable, leading to heightened expectations for the industry. Guidelines such as USP and, along with injectable drug recommendations from the Product Quality Research Institute (PQRI), exemplify this evolving landscape. As drug formulations grow in complexity, a thorough understanding of extractables is essential to mitigate potential risks arising from interactions between packaging and the drug product.

Access the full article to understand how to best manage these risks.