From Heavy Metals Testing to the Measurement of Elemental Impurities in Pharmaceuticals: Over 100 Years in Making the Change

As a follow up to March 2018's "Atomic Perspectives" column, which provided guidance on how to choose the optimum technique for carrying out the measurement of elemental impurities in pharmaceuticals, this month's installment takes a look at the implementation of the new United States Pharmacopeia (USP) Chapters and the International Conference for Harmonization (ICH) guidelines for this method from an historical perspective. This column provides insight into these changes and takes a look at the challenges and opportunities that lay ahead as the industry embraces this new methodology.