| abstract |
improved method for synthesizing pirfenidone. a process for synthesizing pirfenidone from bromobenzene having less than about 0.15% by weight of dibromobenzo is disclosed. also disclosed are processes for synthesizing pirfenidone without using ethyl acetate or n-butanol and pirfenidone having controlled levels of ethyl acetate, n-butanol, di(5-methyl-2-pyridinone)benzenes and other impurities having specified retention times. formulated dosage forms including the disclosed pirfenidone are also disclosed. |