Type of Posting: Revision Bulletin
Posting Date: 29–Dec–2011
Official Date: 01–Jan–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 the Divalproex Sodium Delayed-Release Capsules monograph. The purpose for the revision is to:
- Add Dissolution Test 3 for a product approved by the FDA. The new test was validated using a Zorbax Eclipse XDB-C18 brand of L1 column. The typical retention time for galantamine is about 3.5 min.
- Clarify that the Standard solution in Dissolution Test 1 requires the use of USP Galantamine Hydrobromide RS, and update the concentration to reflect the use of the salt (L/400) rather than the free base (L/500).
The Galantamine Tablets Revision Bulletin supersedes the currently official Galantamine Tablets monograph. This Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org) or Heather Joyce, Ph.D. (301-881-0666 x8442, hrj@usp.org).