BRIEFING

 Tamsulosin Hydrochloride Capsules. This proposal is based on the version of the monograph official as of December 1, 2024. On the basis of comments received, a correction is made to the relative retention times in Table 13 in the test for Organic Impurities. Additionally, it is proposed to revise the monograph with the following changes:

1. In the Assay:

   • Add a Run time in the Chromatographic system section based on supporting data.

   • Add a Note for the relative retention times of tamsulosin and propylparaben based on available information.

2. In the tests for Dissolution:

   • Remove partial cross references.

   • Add System suitability in Test 1 based on supporting documenation.

   • Add dilution factor to the calculation in Test 1 based on supporting documentation.

3. In the test for Uniformity of Dosage Units, remove the Procedure for content uniformity for user flexibility.

4. In the test for Organic Impurities:

   • Add the relative retention time for dessulfotamsulosin to Table 13 based on available information.

   • Revise Table 14 in the Acceptance criteria to list only the limits for specified degradation products, any unspecified degradation product, and total degradation products.

   • The numerical reporting threshold has been replaced with a reference to the general chapter User-Determined Reporting Thresholds 〈477〉 for user flexibility.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 The comment period for this revision ends on September 30, 2026. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of March 1, 2027.

 (SM3: A. Leeks, Jr.)

 Case ID—SUB-1985