SPL Set ID: 5ed8d293-b7d8-4c66-9c31-8075e6f99092
1 drug(s) with this SPL Set ID
Vigabatrin Tablets, USP are an oral antiepileptic drug and are available as 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, insoluble in hexane and toluene. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin 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 (pK a ) of vigabatrin are 4.16 and 9.91 at room temperature (25°C). Each Vigabatrin Tablet contains 500 mg of vigabatrin, USP. The inactive ingredients are microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol. Meets USP dissolution test 3. vigabatrin structural formula