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Extractables & Leachables Testing

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  • Extractables & Leachables Testing

    Filters, containers and other components made of plastic or elastic materials are widely used in pharmaceutical production. When these components are in direct contact with process intermediates and final drugs, some compounds will migrate into the solution. Extractable compounds are compounds that can be extracted from plastics or elastic materials by solvents with different physical and chemical properties under certain conditions. Leachables are compounds that migrate from plastic or elastic materials into drugs under normal conditions of use. GPM guidelines around the world require that the surface in contact with the drug should not be reactive, additive or absorbent, so that the safety, strength, purity or quality of the drug changes and does not meet official requirements or other regulations. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can perform extractables & leachables testing according to industry standards. Welcome to contact our experts for consultation.

    Have you encountered the following problems in the pharmaceutical process

    • What are the acceptance criteria for the amount of extractable and extractable substances?
    • Is the amount in test report within the acceptable range?
    • Faced with various infrared and liquid phase spectra, and various compounds detected, do you feel that you have no way to start?

    If you are suffering from the above troubles, welcome to T,C&A, which is a one-stop third-party material testing laboratory that can help you solve them all.

    Our testing scope includes but not limited to

    • Pharmaceutical packaging
    • Device packaging
    • Container closure systems
    • Drug delivery systems
    • Implantables

    Our extractables & leachables testing items include

    • Non-volatile leachables
    • Volatile and semivolatile leachables
    • Inorganic / elemental leachables

    Our testing techniques include but are not limited to

    Standards we test to

    • USP<1663>, USP<1664>, USP<661>
    • ISO 10993
    • FDA 21 CFR 211.94(a)
    • European Commission Directive (2001/83/EC)

    In addition, the experts in our Extractables & Leachables Testing Laboratory also provide a variety of custom services as your needs and requirements. Let's discuss the custom services with our experts for free.

    Instruments and data

    Extractables and Leachables Testing 1
    Extractables and Leachables Testing 2

    Reference

    1. Lukas, B.; et al. Combined LA-ICP-MS/LIBS: powerful analytical tools for the investigation of polymer alteration after treatment under corrosive conditions. Scientific Reports (Nature Publisher Group) 10.1 (2020).

    Note: this service is for Research Use Only and Not intended for clinical use.

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    T,C& A LAB is an independent lab providing quality or custom testing, characterization and analysis of a variety of materials. Our engaged experts are ready to help you.

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