| 摘要 |
596872 Provided is a process for synthesising pirfenidone using bromobenzene comprising less than 0.15% by weight dibromobenzene, and copper (I) oxide as a catalyst. Further provided are processes for synthesising pirfenidone without using ethyl acetate or n-butanol, and for producing pirfenidone having controlled levels of ethyl acetate, n-butanol, di(5-methyl-2-pyridinone)benzenes, and other impurities. Also provided is a pharmaceutical composition comprising pirfenidone synthesised by the process and processes wherein the pirfenidone synthesised is formulated into dosage forms such as tablets. |
