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 2
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Anagrelide Hydrochloride monograph. The purpose of this revision is to include a process specific impurity, anagrelide open ring methyl ester, with acceptance criteria of NMT 0.25%, to be consistent with the sponsor's FDA-approved specifications. The limit for total impurities remains unchanged.
The Anagrelide Hydrochloride Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in the USP 37–NF 32.
Should you have any questions, please contact Sujatha Ramakrishna Ph.D., M.B.A. (301-816-8349 or sxr@usp.org).