White Paper Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. Potentially toxic and harmful contaminants—including elemental impurities—must be identified, and limits defined for the maximum levels that a patient should be exposed to. In February 2017, new procedures for the analysis of elemental (inorganic) impurities in pharmaceutical products and ingredients were finalized. Existing wet chemical and colorimetric tests, such as European Pharmacopoeia Heavy Metals chapter 2.4.8 and United States Pharmacopeial Convention (USP) General Chapter <231>, have been replaced with instrumental methods. These methods provide specific, quantitative determination of individual ele

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