BRIEFING
Voriconazole Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The proposal for this drug product which appeared in PF 45(3) [May–Jun. 2019] was canceled and is replaced with a new proposal.
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The liquid chromatographic procedure used in the Assay is based on analyses performed with the Xterra RP8 brand of column with L7 packing. The typical retention time for voriconazole is about 5.5 min.
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The liquid chromatographic procedure used in the Dissolution test is based on analyses performed with the Ascentis Express C18 brand of column with L1 packing. The typical retention time for voriconazole is about 2.6 min.
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The liquid chromatographic procedure used in the test for Organic Impurities is based on analyses performed with the Symmetry C18 brand of column with L1 packing. The typical retention time for voriconazole is about 21 min.
(SM1: P. Pabba)
Case ID—SUB-1819, SUB-1820, SUB-1287