SPL Set ID: 178a014b-92c7-44a7-abb8-95d89a2feb8f
1 drug(s) with this SPL Set ID
Valganciclovir for oral solution contains valganciclovir hydrochloride, USP (valganciclovir HCl), 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 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 sodium benzoate, tartaric acid, povidone, sodium saccharin, mannitol and fruity flavoring (banana, peach and pineapple). Composition of banana, peach and pineapple flavor powders: Maltodextrin, silicon dioxide, gum arabic (banana flavor powder and pineapple flavor powder), starch sodium octenyl succinate, triacetin and alpha-tocopherol (peach flavor powder). Valganciclovir hydrochloride, USP is a white to off-white crystalline powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.82. 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 25°C 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 HCl is: All doses in this insert are specified in terms of valganciclovir. structure