In its “Current FDA Perspective on Leachable Impurities in Parenteral and Ophthalmic Drug Products,” presented at an Oct. 22-23, 2011 workshop, the agency defined extractables as "compounds that can be extracted from the container closure system when in the presence of a solvent.” Leachables were described as “compounds that can leach into the drug product formulation from the container closure as a result of direct contact with the formulation.”
The U.S. Pharmacopeial Convention provides information on extractables and leachables (E&L) in its <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and <1664> Assessment of Leachables Associated with Pharmaceutical Packaging/Delivery Systems.
