Fields & Applications Pharma & Biopharma, Mass Spectrometry

Testing and Validation of Various Antacids for Class 1 and 2A Elemental Impurities in Pharmaceutical Products Following ICH Q3D and USP <232>/<233> Using the NexION 2000 ICP-MS

contributed by Perkin Elmer | 05/08/2017

The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products will be implemented on January 1, 2018. General Chapters <232> and <2232> specify the list of elements and their permissible daily exposure (PDE) limits based on the route of administration¹. USP has now harmonized the list of elemental impurities, as well as their PDEs, with the International Conference on Harmonization (ICH) Q3D Step 4 document². In June 2016, the FDA issued guidance on elemental impurities covering ICH Q3D in drug products³.

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