BRIEFING

 Piroxicam Capsules. This proposal is based on the version of the monograph official prior to 2013. On the basis of comments received, the proposal previously published in PF 47(1) [Jan.–Feb. 2021] has been canceled and is being replaced with this new proposal. It is proposed to make the following changes:

1. Replace the TLC procedure in Identification A with the retention time agreement, as obtained in the proposed Assay.

2. Add Identification B based on UV spectrum agreement, as obtained in the proposed Assay.

3. Replace the HPLC procedure in the Assay based on an outdated column with a new HPLC procedure that was validated using the Poroshell 120 EC-C18 brand of column with L1 packing. The typical retention time for piroxicam is about 5.5 min.

4. In the Dissolution test, remove the redundant Note in the Sample solution and revise the Analysis for clarification.

5. Add the test for Organic Impurities based on an HPLC procedure which was validated using the same chromatographic conditions as in the proposed Assay. The typical retention time for piroxicam is about 5.5 min. Stakeholders are encouraged to submit their FDA-approved specifications, if different from the proposed ones, to USP for consideration.

6. Remove the Water Determination test, as the water content can be formulation-specific.

7. Revise the Packaging and Storage section based on manufacturers' approved package inserts.

8. Add USP Piroxicam Related Compound A RS and USP Piroxicam Related Compound B RS to the USP Reference Standards section to support the proposed revisions.

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

 (SM2: W. Yang)

 Case ID—SUB-218