Abstract:

Extractables and Leachables (E&L) studies are critical analyses conducted when developing a pharmaceutical product. These studies assess the potential for chemical compounds to migrate from containers, closures, and other packaging into the drug product. Therefore, E&L assessments are vital to ensure patient safety and consistent product quality.

E&L studies are often under-appreciated in the drug development process. While a generic, one size fits all approach may provide a superficial understanding of potential chemical interactions, it frequently falls short in identifying all E&Ls.

In this white paper, we cover the risks and true cost of inadequate E&L testing.