CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems, is pleased to announce a new service offering specific to USP 1663 Extractable testing and USP 1664 Leachable testing. E&L program requirements play a critical role in the overall evaluation of package system components and their interaction with the drug products they are designed to hold. Drug efficacy and patient safety are at the core of these types of studies.

“The addition of USP 1663 and USP 1664 extractable and leachable testing services is a natural progression to the current USP container and package system qualification work that the CS Team currently performs. Adding E&L testing now enables CS Analytical to offer a full spectrum of package system qualification services across the entire package system lifecycle,” noted Brian Mulhall, CEO of CS Analytical.

The FDA and other regulatory agencies have defined clear guidelines for E&L requirements. Manufacturers are expected to know and understand the potential chemical interactions between the drug product and the package system. While USP 661.1 and USP 661.2 provide a basic extraction profile and are required for routine qualification, in many cases these may not be enough to satisfy E&L regulatory requirements. USP 1663 Extractables studies are designed to identify “substances” in a container closure system that can be “extracted” or pulled out of the components under conditions of stress. As defined under USP 1664, leachables are substances, or chemicals, that come out, or “leach” from, the package system components under normal use conditions. A comprehensive E&L program will include method development, method validation, materials characterization, impurity identification and elemental impurities analysis. A toxicological assessment also plays a crucial role in determining a safety profile score. A variety of laboratory instrumental techniques may also be used and may include HPLC, LC.MC, ICP, NMR, GC/MS.