BRIEFING

 Fludrocortisone Acetate. This proposal is based on the version of the monograph official as of May 1, 2020. The following changes are proposed:

1. Update the chemical names of Fludrocortisone Acetate to be consistent with the USP Dictionary.

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

3. Add Identification B based on the retention time agreement of the major peak of the Sample solution and Standard solution, as proposed in the Assay.

4. Replace the current spectroscopic Assay with a new one based on a liquid chromatographic procedure, which was validated using the LiChrospher 100 RP-18 brand of column with L1 packing. The typical retention time for fludrocortisone acetate is about 15 min.

5. Replace the current TLC-based Organic Impurities test with a new test based on a liquid chromatographic procedure, which was validated using the Gemini C18 brand of column with L1 packing to include specified impurities. The typical retention time for fludrocortisone acetate is about 20 min.

6. Add the storage temperature to the Packaging and Storage section based on approved manufacturer's storage conditions.

7. Add USP Cortisone Acetate RS and USP Epoxyhydrocortisone Acetate RS to the USP Reference Standards section to support the proposed Assay and test for Organic Impurities.

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

 (SM5: G. Daddala)

 Case ID—SUB-1584