BRIEFING
Deflazacort Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.
-
The proposed liquid chromatographic procedures in the Assay and the test for Organic Impurities were validated using the Ultisil XB-C18 brand of column with L1 packing. The typical retention time for deflazacort is about 16 min.
-
The proposed liquid chromatographic procedure in the test for Dissolution was validated using the Ultisil XB-C18 brand of column with L1 packing. The typical retention time for deflazacort is about 11 min.
(SM5: R. Ivaturi)
Case ID—SUB-2448