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Temozolomide

Type of Posting: Revision Bulletin

Posting Date: 31–May–2013

Official Date: 01–Jun–2013

Archive Date: 09–Feb–2015

Expert Committee: Monographs—Small Molecules 3

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Temozolomide monograph. The purpose for the revision is to include the specified impurity, cyanotemozolomide, with limit NMT 0.15% in the Organic impurities to accommodate the sponsor's FDA-approved specification. The limit of total impurities remains unchanged.

The Temozolomide Revision Bulletin supersedes the currently official Temozolomide monograph. The Revision Bulletin will be incorporated in the USP 37–NF 32.

Should you have any questions, please contact R.S. Prasad (301-816-8211 or rsp@usp.org).