Organic Impurities in Drug Substances and Drug Products

As part of an ongoing initiative to modernize monograph standards, USP has proposed drafts of new and revised general chapters related to organic impurities in drug substances and drug products. The USP Organic Impurities in Drug Substances and Drug Products Expert Panel (EP), reporting to the USP 2010–2015 Physical Analysis Expert Committee (EC), was initially 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. The Expert Panel’s work was later expanded to include the development of new General Chapter <476> Organic Impurities in Drug Substances and Drug Products. 
 
The drafts of the new and revised general chapters along with a Stimuli article appear in the May–June 2014 issue of Pharmacopeial Forum. This initiates a 90-day comment period ending on July 31, 2014, and stakeholders are invited to comment. 
 

Contacts

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

Resources

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