SPL Set ID: 1e08a87f-624a-4993-a773-8c660c27b6af
1 drug(s) with this SPL Set ID
Valganciclovir for oral solution, USP 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, USP are mannitol, povidone, propylene glycol, saccharin sodium, sodium benzoate, tartaric acid, and tutti-frutti flavor. 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 390.83. 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 70 mg/mL in water at 25ºC at a pH of 7.0 and an n-octanol/water partition coefficient of 0.0095 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.6. The chemical structure of valganciclovir hydrochloride is: All doses in this insert are specified in terms of valganciclovir. Chemical Structure