依折麦布原料药:氟8.4%-10.2% 杂质A<=0.15% 杂质B<=0.15% 杂质C+D<=0.15% 杂质E<=0.15% 杂质F<=0.15% 其他单杂<=0.1% 总杂<=0.9% 对应异构体<=0.1%
水分<=5.0% 炽灼残渣<=0.2% 重金属<=0.002% 含量98%-102%
依折麦布中间体:1、(4S)-3-[(5S)-5-(4-氟苯基)-5-羟基戊酰基]-4-苯基-1,3-氧氮杂环戊烷-2-酮
2、4-[[(4-氟苯基)亚胺]甲基]-苯酚 脱氧杂质<=0.1% 其他单个杂质<=0.4% 所有杂质总量<=1.0% 水分<=0.3% 炽灼残渣<=1.0% 含量>=98.0%
山东铂源药业有限公司
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