BRIEFING

 Indomethacin Suppositories. This proposal is based on the version of the monograph official as of August 1, 2023. It is proposed to make the following changes:

1. Update the Sample solution preparation in the Assay to allow flexibility and to accommodate FDA-approved products.

2. Add a run time under the chromatographic system of the Assay to be consistent with current USP style.

3. Delete the procedure under the Uniformity of Dosage Units test to allow flexibility.

4. Add a calculation equation under the Analysis of the Dissolution test to be consistent with current USP style.

5. Add an Organic Impurities test based on a validated HPLC method. The liquid chromatographic procedure is based on analyses performed with the Gemini C6-phenyl brand of column with L11 packing. The typical retention time for indomethacin is about 19 min.

6. Update the storage conditions in the Packaging and Storage section, from controlled room temperature to 2°–8° to be consistent with the FDA-approved specifications.

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

 (SM2: M. Fadadu)

 Case ID—SUB-193