Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2014
Official Date: 01–Feb–2014
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 Venlafaxine Hydrochloride Extended-Release Capsules monograph. The purpose for the revision is to add Dissolution Test 9 for a product approved by the FDA.
The liquid chromatographic procedure used in the test for Dissolution, Test 9 is based on analyses performed with a Peerless basic C18 brand of L1 column manufactured by Chromatopak. The typical retention time for venlafaxine is about 4 minutes.
This Venlafaxine Hydrochloride Extended-Release Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).