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Torsemide Tablets

Type of Posting: Revision Bulletin

Posting Date: 25–Jul–2014

Official Date: 01–Aug–2014

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 Torsemide Tablets monograph. The purpose of this revision is to widen the acceptance criteria listed in Table 1 under Organic Impurities section in accordance with the FDA approved specifications.

  • Torsemide related compound A from NMT 0.50% to NMT 0.6%
  • Torsemide related compound E from NMT 0.20% to NMT 0.3%
  • Total Impurities from NMT 0.8% to NMT 1.1%

Several minor editorial changes have also been made to update the monograph to the current USP style.

The Torsemide Tablets Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in First Supplement to USP 38–NF 33

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