Type of Posting: Revision Bulletin
Posting Date: 29–Dec–2011
Official Date: 01–Jan–2012
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Zaleplon monograph. The purpose for the revision is to increase the specifications for Cyanopyrazolamine, Zaleplon Related Compound A, and Zaleplon Related Compound B, in the Organic Impurities test from NMT 0.10% to NMT 0.15% to accommodate the sponsor's FDA-approved specifications.
The Zaleplon Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Hari Ramanathan, M.S. (301-816-8313 or hr@usp.org).