BRIEFING

 Finasteride Tablets. This proposal is based on the version of the monograph official prior to 2013. It is proposed to revise the monograph with the following changes:

1. Add Identification B based on the UV spectrum match in the Assay.

2. Replace the Assay procedure to be consistent with the proposed Organic Impurities test.

3. Update the Dissolution test as follows:

   • Include the Sample solution preparation.

   • Specify the column particle size For products labeled as 5-mg tablets.

   • Delete Capacity factor and Column efficiency under the Suitability requirements as remaining system suitability requirements are sufficient.

4. Add an Organic Impurities test. The liquid chromatographic procedure was validated using the Luna C8(2) brand of column with L7 packing. The typical retention time for finasteride is about 32 min.

5. Update the USP Reference Standards section to include USP Finasteride Related Compound A RS, USP Finasteride Related Compound B RS, and USP Finasteride Related Compound D RS to support the test for Organic Impurities.

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

 (SM5: D. Singh)

 Case ID—SUB-780