Type of Posting: Revision Bulletin
Posting Date: 27–Jan–2012
Official Date: 01–Feb–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 Zolpidem Tartrate Extended-Release Tablets monograph. The purpose for the revision is as follows:
- Revise the tolerance for 240 min pull time in Dissolution, Test 1 to NLT 90% to be consistent with FDA approved specifications.
- Add Dissolution Test 4 for product approved by FDA.
This Zolpidem Tartrate Extended-Release Tablets Revision Bulletin supersedes the currently official Zolpidem Tartrate Extended-Release Tablets 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).