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Moexipril Hydrochloride and Hydrochlorothiazide Tablets

Type of Posting: Revision Bulletin

Posting Date: 21–Nov–2014

Targeted Official Date: 01–Dec–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 Moexipril Hydrochloride and Hydrochlorothiazide Tablets monograph. The purpose of the revision is to widen the acceptance criteria for several impurities listed below under the Organic Impurities section to be consistent with the FDA approved specifications.

  • Moexipril related compound B from NMT 1.00 % to NMT 1.5 %
  • Moexipril related compound A from NMT 1.00 % to NMT 1.0%
  • Benzothiadiazine related compound A from NMT 1.00 % to NMT 1.0 %
  • Any unspecified impurity from NMT 0.20 % to NMT 0.2 %
  • Total impurities from NMT 3.5 % to NMT 4.0 %

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

The Moexipril Hydrochloride and Hydrochlorothiazide Tablets Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in Second 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).