White Paper Overview The United States PharmacopeiaI Convention (USP) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have developed 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 at the end of 2017. These guidelines specify maximum daily exposure limits for the 24 elements listed in Table 1. The full range of elemental impurity analysis can be performed using ICP-MS, including analysis of small sample amounts, and testing parenteral and inhalational medicines, where lower exposure limits apply and

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