Type of Posting: Revision Bulletin
Posting Date: 27–Mar–2015
Official Date: 01–Apr–2015
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 Paroxetine Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 2 to reflect products approved by the FDA.
The liquid chromatographic procedure used for the analysis of the Acid stage sample solution in Dissolution Test 2 is based on analyses performed with a Hypersil-BDS C18 brand of L1 column manufactured by Thermo Scientific. The typical retention time for paroxetine is about 4 min.
The preparation of the Buffer stage medium in Test 1 has been clarified.
Molecular weights of paroxetine and paroxetine hydrochloride have been corrected to be consistent with the USP Dictionary of USAN and International Drug Names.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
This Paroxetine Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 39–NF 34.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).