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Nateglinide

Type of Posting: Revision Bulletin

Posting Date: 27–Aug–2010

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 3

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Nateglinide monograph. The purpose for the revision is to widen the limit for Loss on drying from "NMT 0.2%" to "NMT 0.5%", to reflect the specifications in a recently approved ANDA. In addition, the preparation of the Sample solution under Limit of Nateglinide Related Compound A and Other Impurities is revised to address comments regarding difficulties in dissolving the analyte.

The Nateglinide monograph Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 34–NF 29.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or EG@usp.org).