White Paper Overview The United States Pharmacopoeia (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are responsible for developing new standards to test for inorganic (elemental) impurities in pharmaceutical products and ingredients: USP General Chapters <232> (Elemental Impurities – Limits) and <233> (Elemental Impurities – Procedures) and ICH-Q3D were finalized in February 2017 and implemented on 1st January 2018. These guidelines specify maximum daily dose limits for the 24 elements listed in Table 1. ICP-OES and ICP-MS are the reference instrumental techniques for the analysis of Elemental Impurities. ICP-MS is the more suitable technique for analysis of drug products and materials intended for parenter

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