Ensure that the materials your product comes into contact with do not affect its safety or efficacy, and that your product satisfies all FDA extractables and leachables (E&L) testing requirements.
AMRI’s multidisciplinary team of material scientists, analytical chemists, biomedical engineers, toxicologists and biocompatibility specialists deliver E&L evaluations critical for successful product development and regulatory submissions. Our experts offer strategic vision and develop novel solutions, guiding you through the process to meet your needs in extractables/leachables and impurities.
We base our E&L studies on the recommendations of the Product Quality Research Institute’s Extractables and Leachables Working Group to the FDA, USP <1663>, USP <1664>, the Bio-Process Systems Alliance Extractables and Leachables Subcommittee, FDA container closure guidance, and ISO 10993 Part 18, Biological Evaluation of Medical Devices (chemical characterization of materials).
Contact our analytical testing team by clicking below