Extractables & Leachables Chemical Analyis
Smithers chemical analysis expertise encompasses medical devices, primary container closure systems, secondary packaging components, single use processing systems as well as excipient and API analysis:
USP <665>, USP <1665> and BPOG Extractables Protocol - Reviewing Single Use Technology (SUT) Extractables and Leachables (E&L) Testing
Updated October 2025
As USP standards evolve, the testing requirements are evolving as well. If you require consultative support, testing services, or training, please contact one of our experts.
New USP <665> and <1665> Effective Date
New USP standards are coming, as USP <665> and <1665> were officially approved early 2024. To allow time for implementation, the USP General Chapters–Packaging and Distribution Expert Committee has extended the official effective date to May 1, 2026.
A Smithers expert can provide you with the support needed to identify a path forward.
Where do USP Chapters Apply?
USP <665> governs Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. USP <1665> governs Characterization and Qualification of Plastic Components and Systems used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. Both USP <665> and USP <1665> provide new guidance, including a focus on risk-based assessments.
Smithers team of experts are familiar with the new guidelines and work to ensure that our testing methods meet all your requirements, including investment in a facility to cater for large, small, and unique systems. Our experts are recognized for their diligence in supporting clients through the risk assessment and testing process and have created a summary chart of the new USP <665> and <1665>.
Contact our experts to learn about how we can support with your chemical safety assessment and find out more about the extractables and leachables testing and medical device testing services that Smithers offers.