Extractables and Leachables (E&L) testing is an important step to verify the safety for your combination product. This is typically performed by testing materials with a wide variety of analytical instrumentation to determine what compounds could end-up in your drug product during its shelf life. DDL works with industry experts to design a test program that provides insight on material selection of your combination product.
- USP 1663 Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
- USP 1664 Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
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