SPL Set ID: b856bfaf-ec6b-4171-81c4-b9b07f780084
1 drug(s) with this SPL Set ID
Valganciclovir hydrochloride for oral solution contains valganciclovir hydrochloride (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 hydrochloride for oral solution are mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring. Valganciclovir HCl, USP is a white to off-white crystalline powder with a molecular formula of C 14 H 22 N 6 O5·HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is: All doses in this insert are specified in terms of valganciclovir. figure-2