Type of Posting: Revision Bulletin
Posting Date: 29–Apr–2011
Official Date: 01–May–2011
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Oxybutynin Chloride Extended-Release Tablets monograph. The purpose for the revision is to add details to the testing procedure, to clarify the sampling times, and to correct the calculations under Dissolution Test 2.
Minor editorial changes have been made under Dissolution tests. 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 for each Dissolution test.
The Oxybutynin Chloride Extended-Release Tablets Revision Bulletin supersedes the currently official Oxybutynin Chloride Extended-Release Tablets monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.
Should you have any questions, please contact Margareth Marques, Ph.D. (301-816-8106 or mrm@usp.org).