2H-1,2-Benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-N-2-pyridinyl-, 1,1-dioxide;
4-Hydroxy-2-methyl-N-2-pyridyl-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide
4-Hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzo[e][1,2]thiazine-3-carboxamide 1,1-dioxide [36322-90-4]
BRIEFING
Piroxicam. This proposal is based on the version of the monograph official as of December 1, 2020. On the basis of comments received, it is proposed to revise the monograph with the following changes:
-
Update the chemical name of piroxicam.
-
Update the Definition from the as-is basis to calculated on the dried basis based on the FDA-approved specification.
-
Update the basis for the Acceptance criteria in the Assay to align with the revised Definition.
-
In the test for Limit of Piroxicam Related Compound B:
-
Change the Diluent from methanol to acetonitrile based on supporting information.
-
Add a note to recommend the storage temperature for solutions containing piroxicam related compound B. Revisions are made accordingly for the System suitability solution, Standard solution, and Sample solution.
-
Add the Sensitivity solution and the Signal-to-noise ratio requirement.
-
-
In the test for Organic Impurities:
-
Add the wavelength for the Resolution in the Detector of the Chromatographic system.
-
Add a table and Note in the System suitability section to present relative retention times as an aid in peak assignment. Revise the table in the Acceptance criteria section to list only the limits for specified impurities, any unspecified impurity, and total impurities. Add the reporting threshold and reference to User-Determined Reporting Thresholds 〈477〉.
-
-
Replace the Water Determination 〈921〉 test with the Loss on Drying 〈731〉 test to align with the revised Definition.
-
Update the chemical information in the USP Reference Standards section.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM2: F. Gu)
Case ID—SUB-1619, SUB-2549, SUB-2707