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Losartan Potassium Tablets

Type of Posting: Revision Bulletin

Posting Date: 27–Apr–2012

Official Date: 01–May–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 Tablets monograph. The purpose for the revision is to:

  • Add Dissolution Test 3 for a generic product and to correct footnote c in Table 4 under Organic Impurities. The liquid chromatographic procedure in the Dissolution Test 3 is based on analyses performed using a Zorbax SB-C8 column of packing L7. The typical retention time for losartan is about 2 min.
  • Revise footnote c in Table 4 to match with the validation data.

The Losartan Potassium Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on 30–Jun–2011 which became official 01–Jul–2011 and is being incorporated in USP 35–NF 30. This Revision Bulletin will be incorporated in USP 36–NF 31.

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