Type of Posting: Revision Bulletin
Posting Date: 27–Aug–2010
Official Date: 01–Oct–2010
Expert Committee: Monographs—Small Molecules 3
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Molecules 3 Expert Committee has revised the monograph for Tamsulosin Hydrochloride Capsules. The purpose for the revision is to accommodate seven generic versions of this product recently approved by FDA as follows:
- Seven new Dissolution tests
- Seven Assay Procedures, corresponding to the seven newly added Dissolution tests to address recovery problems reported by generic manufacturers
- Identification–A test deleted, to address comments that the excipient matrices in newly approved formulations may interfere with the UV spectrum of the analyte
The Tamsulosin Hydrochloride Capsules Revision Bulletin supersedes the currently official 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., for Dissolution (301-816-8106 or mrm@usp.org) and Elena Gonikberg, Ph.D., for all the other tests (301-816-8251 or eg@usp.org).