Appearing in the May-June 2014 issue of the Pharmacopoeial Forum (PF) were a draft chapter proposal and a draft chapter revision updating USP’s coverage of organic impurities. The revision of general chapter <1086> on drug substance/product impurities and the proposal for the addition of a chapter <476> on drug substance/product organic impurities, which will align USP with ICH Q3A and Q3B, are open for comment until July 31, 2014. Included in the PF issue was a stimuli article detailing the rationale, scope, and implementation of the changes.
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