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Cefdinir for Oral Suspension

Type of Posting: Revision Bulletin

Posting Date: 27–Sep–2013

Official Date: 01–Oct–2013

Archive Date: 09–Feb–2015

Expert Committee: Monographs—Small Molecules 1

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Cefprozil monograph. The purpose of the revision is to revise Organic Impurities Procedure 2 to widen the limits for cefprozil related compound D (Z) and (E)-isomers from 0.2% to 0.30% and the limit for total impurities from 1.5% to 2.00%.

The Cefprozil Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 37–NF 32.

Should you have any questions, please contact Ahalya Wise, Senior Scientific Liasion (301-816-8161 or aww@usp.org).