Organic Impurities in Drug Monographs

As part of an ongoing modernization initiative, USP is updating its USP–NF general chapters related to organic impurities testing for drug products. The USP Impurities in Drug Products Expert Panel (EP), reporting to the USP 2010–2015 Physical Analysis Expert Committee (EC), has been established and charged with revising General Chapter <1086> Impurities in Drug Substances and Drug Products, which also references General Chapter <466> Ordinary Impurities and General Notices 5.60. With members from industry, FDA and three other USP ECs, the EP will recommend general chapter revisions that will help ensure better control of organic impurities and degradants in drug products. The EP’s work will focus on over-the-counter (OTC) and prescription products.

Contact: Antonio Hernandez-Cardoso, Senior Scientific Liaison, General Chapters (ahc@usp.org or 301-816-8308).

White Paper: Modernization of Organic Impurities in USP Drug Product Monographs