SPL Set ID: 4aaea88b-e0fd-45e3-bb02-604bf8ee9b5b
1 drug(s) with this SPL Set ID
Vigabatrin tablets, USP are an oral antiepileptic drug and are available as white to off-white film-coated 500 mg tablets. The chemical name of vigabatrin, 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, very slightly to practically insoluble in alcohol, practically insoluble in methylene chloride, and insoluble in 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 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 and 9.7 at room temperature (25°C). Each vigabatrin tablet, USP contains 500 mg of vigabatrin USP. The inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide. FDA approved dissolution test specifications differ from USP. str