依折麥布原料藥:氟8.4%-10.2% 雜質(zhì)A<=0.15% 雜質(zhì)B<=0.15% 雜質(zhì)C+D<=0.15% 雜質(zhì)E<=0.15% 雜質(zhì)F<=0.15% 其他單雜<=0.1% 總雜<=0.9% 對(duì)應(yīng)異構(gòu)體<=0.1%
水分<=5.0% 熾灼殘?jiān)?lt;=0.2% 重金屬<=0.002% 含量98%-102%
依折麥布中間體:1、(4S)-3-[(5S)-5-(4-氟苯基)-5-羥基戊?;鵠-4-苯基-1,3-氧氮雜環(huán)戊烷-2-酮
2、4-[[(4-氟苯基)亞胺]甲基]-苯酚 脫氧雜質(zhì)<=0.1% 其他單個(gè)雜質(zhì)<=0.4% 所有雜質(zhì)總量<=1.0% 水分<=0.3% 熾灼殘?jiān)?lt;=1.0% 含量>=98.0%
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