Pharmaceutical Technology - September 2021

Pharmaceutical_Technology_PTE_Regulatory_Sourcebook_September_2021

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Impurities in Pharmaceuticals Jordi Labs' inorganic chemists have specific expertise in elemental analysis and work with the latest instrumentation. We provide a quick turnaround for method development, validation and analysis. In early 2018, the Food and Drug Administration (FDA) – with the support of the International Council for Harmonisation (ICH) and the U.S. Pharmacopeial Convention (USPC) – established new guidelines for elemental impurities in brand and generic drug products. These guidelines, published as USP 232, concern manufacturers of goods as varied as surgical bags, filters, tubes, and dietary supplements. Regulatory pharmaceutical testing for impurities is subsequently a matter of necessity. Contact a member of the Jordi Labs team today to learn more. Integrity, innovation and teamwork are the "Jordi Way". These core beliefs have guided our business since we started in 1980. jordilabs.com Materials Analysis Lab Testing

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