SPL Set ID: fff10d69-e334-42bd-baed-7d9d5feef6aa

Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion. The structural formula is: Voriconazole is designated chemically as (α R , β S )-α-(2, 4-Difluorophenyl)-5-fluoro-β-methyl-α-(1 H -1, 2, 4-triazol-1-ylmethyl)-4-pyrimidineethanol. The molecular formula of voriconazole is C 16 H 14 F 3 N 5 O and its relative molecular mass is 349.31. Voriconazole USP, drug substance is a white or almost white powder. Voriconazole for injection is a sterile, white to off white lyophilized cake or powder containing nominally 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration ( 2 )]. voriconazole-structure