Application Note: Implementation of USP New Chapters <232> and <233> on Elemental Impurities in Pharmaceutical Products
4 November 2013
This whitepaper is intended to keep the pharmaceutical community abreast of the latest developments with regard to the new chapters on elemental impurities in pharmaceutical products in the United States Pharmacopeia’s (USP) National Formulary (NF). It provides an overview of the salient points described in Chapter <232> on Elemental Limits and Chapter <233> on Analytical Procedures and offered suggestions as how best to approach the determination of elemental impurities in pharmaceutical products using PerkinElmer ICPAES/ OES and ICP-MS instrumentation. It is meant to be the first step in educating pharmaceutical laboratories and explaining why the old “Heavy Metals Test”, described in Chapter <231> is being replaced with these two brand new chapters. The approval of Chapter <2232> –“Elemental Contamination of Dietary Supplements” – is still going through the USP review and comments process.