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Losartan Potassium

Type of Posting: Revision Bulletin

Posting Date: 29–Dec–2011

Official Date: 01–Jan–2012

Expert Committee: Monographs—Small Molecules 2

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Losartan Potassium monograph. The purpose of the revision is to accommodate the recently approved specifications for a generic product as follows:

  • Under Identification Test A, a note is added to provide flexibility to use <197K>.
  • The test for Water Determination is revised to provide separate requirements for an amorphous form of Losartan Potassium.
  • The above revisions necessitate the addition of a Labeling statement.

The Identification test procedure using <197K> and specification for Water content for the amorphous form were previously published as an Authorized Pending Monograph revision.

This Revision Bulletin supersedes the currently official Losartan Potassium monograph. The Revision Bulletin will be incorporated in the Second Supplement to the USP 35–NF 30.

Should you have any questions, please contact Sujatha Ramakrishna Ph.D., M.B.A. (301-816-8349 or sxr@usp.org).