| abstract |
A process to synthesize pirfenidone from bromobenzene with less than about 0.15% by weight of dibromobenzene. Also, processes for synthesizing pirfenidone without using ethyl acetate or n-butanol, and pirfenidone with controlled levels of ethyl acetate, n-butanol, di (5-methyl-2-pyridinone) benzenes, and other impurities with retention times that are specified. Also, dosage forms that are formulated including the pirfenidone that is disclosed. Claim 1: A method of synthesizing pirfenidone characterized in that it comprises mixing bromobenzene, 5-methyl-2-pyridone, cuprous oxide, and an organic solvent in conditions sufficient to form pirfenidone, wherein the bromobenzene comprises less than about 0.15% by weight or as molar ratio of dibromobenzene. |