Extractables and Leachables

Advantar provides expertise in designing scientifically supportable positions to testing Extractables and Leachables (E&L) such as monomers/dimers, antioxidants, plasticizers, stabilizers and other impurities that may potentially migrate into a drug product. Leachable accumulation can result from a variety of sources depending on the type of product, the manufacturing/packaging space, potential for cross-contamination, cleaning protocols as well as primary or secondary container types.

Study design for E&L testing include the following:

• Study designs to support Risk-based Manufacturing of Pharmaceutical Products (Risk-MaPP) for Extractables and Leachables (E&L) testing (based on the ICH Q9)
• Extractables profiling, isolation and characterization
• Determination & Qualification of the analytical parametersMethod development and validation of targeted leachables
• Leachables study to monitor potential migratory chemicals throughout drug product shelf-life