White Paper Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. To achieve this, potentially harmful contaminants—including elemental impurities—must be identified, and limits defined for the maximum allowable exposure to them. In February 2017, 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. This methods provide specific, quantitative determination of individual elemental impurit

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