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Tamsulosin Hydrochloride Capsules

Type of Posting: Revision Bulletin

Posting Date: 30–Sept–2011; updated 13–Oct–2011*

Targeted Official Date: 01–Oct–2011

Expert Committee: Monographs—Small Molecules 3

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Tamsulosin Hydrochloride Capsules monograph. The purpose for the revision is to delete the use of sinkers under Dissolution Test 4 to make it consistent with the FDA-approved specifications of the sponsor. In addition, the preparation of the Buffer stage medium under Dissolution Test 1 is corrected, and the reference to Acceptance Table 2 in Dissolution <711> is added under Dissolution Test 2.

The Tamsulosin Hydrochloride Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in First Supplement to USP 35–NF 30.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).

* Replaced Revision Bulletin file to remove shading from previous revisions. The shading is retained only for the text affected by the current Revision Bulletin. No text was changed.