Zolpidem Tartrate Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Posting Date: 
30–Jun–2011
Official Date: 
01–Jul–2011
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:

  • Add Dissolution Test 2 and Test 3 for products approved by FDA.
  • Correct the relative response factor (RRF) for zolpidem acid in the Organic impurities test.

Minor editorial changes have been made under Dissolution, Test 1. When Acceptance Table 2 is specified under Tolerances, a reference to the General Chapter <711> Dissolution is added, and the text referring to the Acceptance Table 2 is moved to the end of the Tolerances section.

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 USP 35–NF 30.

Should you have any questions, please contact Hari Ramanathan, M.S. (301-816-8313 or hr@usp.org).