4031 Ready Methods Reduce E&L Timelines

Working groups like Product Quality Research Institute (PQRI) and guidance chapters like USP <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems provide direction. For small molecule drug products, manufacturers must understand these guidances and determine how to apply them for extractables and leachables evaluations of individual drug products.

With expertise in both materials science, and extractables and leachables evaluations for pharmaceutical packaging components and delivery devices, West Analytical Services has an established approach for executing extractables and leachables evaluations for individual drug products.