Type of Posting: Revision Bulletin
Posting Date: 30–Sep–2010; updated 28–Jan–2011*
Official Date: 01–Oct–2010
Expert Committee: Monographs—Small Molecules 2
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 (SM2) Expert Committee has revised the Nifedipine Extended-Release Tablets monograph. The purpose for the revision is to revise the preparation of the Standard solution in Dissolution Test 7 and to add a Dissolution Test 8.
The Nifedipine Extended-Release Tablets Revision Bulletin supersedes the currently official Nifedipine Extended-Release Tablets monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 34–NF 29.
Should you have any questions, please contact Margareth Marques, Ph.D. (301-816-8106 or mrm@usp.org).
*This posting on 28 January 2011 replaces the 30 September 2010 posting; only the 28 January 2011 posting is available. The 30 September 2010 posting introduced a revision to Dissolution Test 7 and added Dissolution Test 8 and indicated an official date of 1 October 2010. The purpose of this update is to clarify and correct differences in the version of the monograph posted on 30 September 2010:
- Figure 1 in Dissolution Test 2 was replaced by a reference to the identical figure in General Chapter <711> Dissolution. To clarify, this is considered an editorial change and not a revision so there is no indication of change in the monograph.
- In the Revision Bulletin posted on 30 June 2010 (official 1 August 2010), Identification Test B included a Standard solution and a Sample solution. In the 30 September 2010 Revision Bulletin, there was a style change and the Standard solution preparation was rewritten to include a Standard stock solution and a Standard solution. Similarly, the Sample solution was rewritten to indicate a Sample stock solution and a Sample solution. These were editorial changes and did not require an indication of change in the monograph.
- The Tolerances table "For Tablets labeled to contain 60 mg of nifedipine: Phase 2" (now called Table 4) was inadvertently omitted in the Revision Bulletin posted on 30 June 2010. Table 4 was then reinserted in the monograph in the 30 September 2010 posting; however, this correction was not explained.
- Table 8 for Dissolution Test 6 was inadvertently omitted from the 30 September 2010 posting. This Table has been reinserted into the monograph. An entry for this item will be included in the Errata Table that will be posted in March 2011.
There are no revisions to the content of the Dissolution Tests or Tables or any other sections of the monograph and there is no change to the official date of 1 October 2010. This update reflects the corrected monograph and replaces the monograph posted on 30 September 2010.