In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Cefazolin Sodium monograph. The purpose of the revision is to widen the limit of cefazoloic acid isomers from NMT 0.5% to NMT 1.0% to accommodate the sponsor’s FDA-approved acceptance criteria. A note is also added to clarify that three isomers of this impurity, namely cefazolin open-ring delta-3, cefazolin open-ring delta-2, and cefazolin open-ring delta-4, may not be fully resolved by this method, and the limit applies to the sum of the isomers.
The Cefazolin Sodium Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in Second Supplement to USP 34–NF 29.
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