BRIEFING

 Dexamethasone Tablets. This proposal is based on the version of the monograph official as of Sept. 12, 2023. On the basis of comments received, the previous proposal that appeared in PF 45(6) [Nov.–Dec. 2019] was canceled and is replaced with the following proposal. It is proposed to revise the monograph with the following changes:

1. Add an LC procedure in the test for Organic Impurities based on validated methods of analysis. The proposed procedure is based on analyses performed with the Acquity UPLC BEH C18 brand of column with L1 packing. The typical retention time for dexamethasone is about 8.5 min.

2. Replace the LC procedure in the Assay to be consistent with the LC procedure specified in the test for Organic Impurities. The typical retention time for dexamethasone is about 8.5 min.

3. Replace the Thin-Layer Chromatography test with a new Identification A based on the retention time agreement as obtained in the proposed Assay.

4. Add Identification B to the Identification section, which is based on the UV spectra agreement as obtained in the Assay.

5. Remove the cross-reference of the Standard solution and Analysis to Assay for Steroids 〈351〉 and add the Standard solution and Analysis sections in Dissolution Test 1.

6. Delete the Procedure for content uniformity in the Uniformity of Dosage Units test to allow for more flexibility in performing the analysis.

7. Update the Packaging and Storage section to include storage conditions consistent with the product label.

8. Add USP Betamethasone RS to the USP Reference Standards section to support the proposed Organic Impurities test.

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

 (SM5: N. Myers)

 Correspondence Number—C322040