BRIEFING

 Dutasteride and Tamsulosin Hydrochloride Capsules. This proposal is based on the version of the monograph official as of May 1, 2024. It is proposed to revise the monograph with the following changes:

1. In the Assay, update Procedure 1: Dutasteride and Procedure 2: Tamsulosin Hydrochloride to clarify the respective Sample solution preparations for improved flexibility.

2. Delete the test for Content of Butylated Hydroxytoluene.

3. Under the Dissolution test in the Test for dutasteride, restate the Buffer and Mobile phase preparations, and the Chromatographic system details to be consistent with current USP style.

4. Update the Organic Impurities, Procedure 1: Dutasteride and Organic Impurities, Procedure 2: Tamsulosin Hydrochloride tests as follows.

   • Under the Acceptance criteria, the numerical reporting threshold has been replaced with a reference to general chapter User-Determined Reporting Thresholds 〈477〉 for user flexibility. For more information about this change, please see the USP Compendial Notice "New Chapter 〈477〉 User-Determined Reporting Thresholds and its Implementation in USP-NF Monographs".

   • Update the Sensitivity solution concentration of Dutasteride from 0.35 µg/mL to 0.7 µg/mL and the concentration of Tamsulosin Hydrochloride from 0.05 µg/mL to 0.1 µg/mL to align with a reporting threshold of 0.1%.

   • Clarify the respective Sample solution preparations for improved flexibility.

5. In the USP Reference Standards section, delete USP Butylated Hydroxytoluene RS.

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

 (SM3: L. Lasker)

 Case ID—SUB-1197