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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 FDA issued a draft guidance in July 1998 (1"The Tan Sheet" Aug. 10, 1998, In Brief)

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ANDA impurities guidance

Draft document provides guidance on including in ANDAs and drug master files information on "identification and qualification of impurities in drug substances" for monograph and nonmonograph drugs. Impurities are classified in the July 24 document as either chemistry- or safety-related; the document provides guidance on "qualifying impurities" in the ANDA product compared to the "related USP monograph, the scientific literature or innovator material" -- specifically, when impurities in the ANDA products are at higher or lower levels than these benchmarks or are not found in the references at all -- and provides "threshold levels, below which qualification is not needed." Comments on the draft guidance are due within 60 days of publication...

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