SPL Set ID: e9c99000-fc0c-4083-b620-ba9ac821f8ac
1 drug(s) with this SPL Set ID
Vigabatrin Tablets, USP is an oral antiepileptic drug and is available as a white to off-white film-coated 500 mg tablets. The chemical name of vigabatrin USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6 H 11 NO 2 and the molecular weight is 129.16. It has the following structural formula: Vigabatrin, USP is a white or almost white powder which is freely soluble in water, slightly soluble in methanol; practically insoluble in methylene chloride. The pH of a 1% aqueous solution is about 6.9. The noctanol/ water partition coefficient of vigabatrin, USP is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin, USP are 4 and 9.7 at room temperature (25°C). Each vigabatrin tablet contains 500 mg of vigabatrin, USP. The inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Image