Type of Posting: Revision Bulletin
Posting Date: 28–Oct–2011
Official Date: 01–Nov–2011
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 Diltiazem Hydrochloride Extended-Release Capsules monograph. The purpose for the revision is to add Dissolution Test 16 for a recently approved generic product. Please note that the Acceptance Table in Test 1 is deleted, and a reference to the same Acceptance Table 2 (General Chapter <711>) has been included.
Minor editorial changes have been made under all Dissolution tests. Similar to Dissolution Test 1, a reference to General Chapter <711> is made to Acceptance Table 2, wherever specified, for clarity. In addition, the text referring to the Acceptance Table 2 is moved to the end of the Tolerances section for each Dissolution test.
The Diltiazem Hydrochloride Extended-Release Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in First Supplement to USP 35–NF 30.
Should you have any questions, please contact Sujatha Ramakrishna Ph.D., M.B.A. (301-816-8349 or sxr@usp.org).