ANDA impurities
This article was originally published in The Tan Sheet
Executive Summary
Guidance for industry entitled "ANDAs: Impurities in Drug Substances" offers suggestions on what information to include in abbreviated new drug applications and drug master files concerning the content and qualification of drug substance impurities incurred by chemical syntheses for monograph and nonmonograph drugs. Published in the Dec. 3 Federal Register, the guidance provides specific recommendations on: qualifying impurities in an ANDA substance by comparing them to impurities found in a related U.S. Pharmacopeia monograph, scientific literature or innovator data; qualifying impurities found at higher levels than in the USP or other materials; qualifying impurities in an ANDA substance not found in the USP or other materials; and setting threshold levels under which qualification is not necessary. FDA issued a draft guidance in July 1998 (1"The Tan Sheet" Aug. 10, 1998, In Brief)