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).

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