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 monograph. The purpose of the revision is as follows:
- Widen the acceptance criteria listed in Table 2 under Organic Impurities section in accordance with the FDA approved specifications.
- Moexipril related compound A from NMT 0.15% to NMT 0.2 %
- Moexipril related compound B from NMT 0.15% to NMT 0.2 %
- Revise the storage conditions from store at 2° -8° under nitrogen to store at room temperature
The Moexipril Hydrochloride 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).