Extractables & Leachables Testing

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  • Published date: September 13, 2021
    • United States

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.


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Tylor Keller
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