![]() USP’s Pharmaceutical Analytical Impurities, like official USP Reference Standards, can help you to save time and resources, and reduce risks associated with quality and consistency related to nitrosamine drug substance-related impurities (NSDRIs). test for and profile impurities not listed in drug substance and drug product monographs.identify impurities which are present in the Reference Listed Drug.identify unknown impurities that formed during ICH stability conditions.perform spiking studies during process R&D to demonstrate depletion upon recrystallization.develop, validate and transfer analytical methods.determine degradation impurities produced during stress studies.All rights reserved 100 Majestic Way, Bangor, PA. conduct analytical tests during early formulation feasibility studies Biospectra is a FDA registered US Manufacturer of cGMP pharmaceutical.Each USP PAI is supported by its own Product Information Sheet with details on identity and purity and can be used in various applications: USP’s Pharmaceutical Analytical Impurities (PAI)* advances your early analytical R&D and process development. ![]() Why you need Pharmaceutical Analytical Impurities As a leading provider of official Reference Standards trusted by thousands of manufacturers and regulators around the world, USP offers PAI analytical reference materials to support your impurity-related needs. PAI products include impurities listed in USP monographs but not available as USP Reference Standards as well as critical degradants and process impurities. BOSTON, November 25, 2022-Spectrum Pharmaceuticals, Inc. Our PAI portfolio now has over 400 impurity analytical reference materials covering 75 Active Pharmaceutical Ingredients (APIs) across 15+ therapeutic categories. 200 New Pharmaceutical Analytical Impurities have been added to our catalog.
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