Mefloquine Hydrochloride

Type of Posting: 
Revision Bulletin
Posting Date: 
28–Jan–2011
Official Date: 
01–Feb–2011
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 Mefloquine Hydrochloride monograph. The purpose of this revision is to accommodate the sponsor's FDA-approved specifications by widening the acceptance criteria in the Definition from 99.0%–101.0% to 98.0%–102.0%. In addition, a standard deviation of NMT 1.0% is added to the System suitability requirements of the Assay procedure.

The Mefloquine Hydrochloride Revision Bulletin supersedes the currently official monograph and replaces the monograph in Supplement 2 to the USP 33–NF 28 Reissue, which was scheduled to become official on February 1, 2011. The Revision Bulletin will be incorporated into the Second Supplement to USP 34–NF 29.

Should you have any questions, please contact Leonel Santos (301-816-8168 or lxs@usp.org).