Elemental Impurities ICH Guidelines: Roadmap to Compliance for Your Drug Products
ICH Q3D has been adopted worldwide since 2018 and applies now for all existing and new drug products. Existing wet chemical and colorimetric heavy metal quantification tests, such as Ph. Eur. Heavy metals chapter 2.4.8 and USP<231>, have been replaced with methods that use modern instruments to quantify specific elements in drug products and ingredients. While the existing wet chemistry methods have been in effect for nearly 100 years, they are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients.