Type of Posting: Revision Bulletin
Posting Date: 29–Dec–2011
Official Date: 01–Jul–2012
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Pending to Official Status
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has approved the Venlafaxine Hydrochloride Extended-Release Capsules monograph to move from an Authorized Pending Monograph to official USP–NF status because the FDA has approved the sponsor’s application. In addition, the Expert Committee has also approved inclusion of Dissolution Test 2 and Test 3 for products approved by the FDA.
In accordance with the “Implementation Process for Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations”, the Nomenclature, Safety, and Labeling Expert Committee has approved the revision of the title of the Venlafaxine Extended-Release Capsules monograph to “Venlafaxine Hydrochloride Extended-Release Capsules.” The policy is available at: https://www.uspnf/notices/retired-compendial-notices/usp-nomenclature-policy
The liquid chromatographic procedure in the tests for Assay and Organic Impurities is based on analyses performed with a Zorbax SB-C18 brand of L1 column. The typical retention time for venlafaxine peak is about 6.8 min.
The liquid chromatographic procedure in the test for Dissolution, Test 1 is based on analyses performed with a Zorbax SB-C18 brand of L1 column. The typical retention time for venlafaxine peak is about 2.6 min.
Dissolution, Test 2 is based on UV spectrometric analysis with maximum absorbance measured at 274 nm.
The liquid chromatographic procedure in Dissolution, Test 3 is based on analyses performed with a Hypersil BDS brand of L1 column. The typical retention time for venlafaxine peak is about 4.4 min.
The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Hari Ramanathan, M.S. (301-816-8313 or hr@usp.org).