BRIEFING

 Finasteride. This proposal is based on the version of the monograph official as of May 1, 2020. It is proposed to revise the monograph with the following changes:

1. Update the chemical information section to reflect the molecular weight as per the current USP Dictionary of USAN and International Drug Names.

2. Revise Identification A to allow the flexibility of using either 197A or 197M.

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

4. Revise the Acceptance criteria in the Assay from 98.5%–101.0% to 98.0%–102.0%, which is typical for a liquid chromatographic procedure. The Definition is revised accordingly.

5. Replace the chromatographic purity test with a new 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.

6. Revise the Specific Rotation 〈781S〉 test and Acceptance criteria for harmonization with the European Pharmacopoeia.

7. 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-779