SPL Set ID: ddfb4e0e-64f5-4654-8670-91b8b6abe794
1 drug(s) with this SPL Set ID
Valganciclovir for oral solution contains valganciclovir hydrochloride, USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride, USP is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are fumaric acid, mannitol, povidone K-29/32, saccharin sodium, sodium benzoate, and tutti-frutti flavoring. Valganciclovir hydrochloride, USP is a white to off-white powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.8. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 100 mg/mL in water at 25°C at a pH 7.0 and an n-octanol/water partition coefficient of -2.37 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.2. The chemical structure of valganciclovir hydrochloride is: All doses in this insert are specified in terms of valganciclovir. Chemical Structure