BRIEFING

 Voriconazole for Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures used in the Assay and the test for Organic Impurities are based on analyses performed with the Symmetry C18 brand of column with L1 packing. The typical retention times for voriconazole are about 6.5 and 20.5 min, respectively. The liquid chromatographic procedure used in the Limit of Voriconazole Related Compound B test is based on analyses performed with the Chiralpak IC-3 brand of column with L119 packing. The typical retention time for voriconazole related compound B is about 12 min.

 (SM1: P. Pabba)

 Case ID—SUB-1025