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托法替尼申报用杂质
点击次数:1059 更新时间:2017-02-23

枸橼酸托法替尼背景及作用机理:

枸橼酸托法替尼是由美国辉瑞制药公司开发一种治疗类风湿关节炎药物,商品名Xeljanz,用于对氨甲喋呤治疗应答不充分或不耐受的中至重度活动性类风湿关节炎(RA)成人患者。本产品是一种Janus激酶抑制剂,每日服用两次。
2012年11月6日,美国食品药品管理局(FDA)和辉瑞公司联合宣布,枸橼酸托法替尼获准用于对氨甲喋呤治疗应答不充分或不耐受的中至重度活动性类风湿关节炎(RA)成人患者。
Xeljanz可作为单一治疗或与氨甲喋呤或其他非生物疾病缓解性抗风湿药物(DMARD)联合使用。该药不应与生物性DMARD或强免疫抑制剂(如硫唑嘌呤和环孢菌素)联合使用。经核准的Xeljanz剂量为每日2次,每次5mg。

 

深圳远扬化学可提供托法替尼申报所用全套杂质, 随货附CoA证书,HNMR,MS,HPLC图谱,纯度符合申报要求,托法替尼杂质为我司优势杂质,长期备有库存,发货快。如需托法替尼杂质相关详细信息,欢迎我司业务人员获取~

 

除自主品牌杂质对照品外,我司还代理英国NIBSC标准品,美国剑桥CIL同位素标准品,美国NIST标准物质,欧洲标准局IRMM标准物质,加拿大TRC标准品,TLC标准品,MOLCAN标准品,NRC标准品等,欢迎洽谈。

 

附:托法替尼申报用杂质列表:

Tofacitinib3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 1N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-1H-indol-4-amine
Tofacitinib Impurity 22-chloro-N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine
Tofacitinib Impurity 33-((3R,4R)-3-((2-chloro-7H-pyrrolo[2,3-d]pyrimidin-4-yl)(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 43-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 53-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxoprop*
Tofacitinib Impurity 63-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoic acid
Tofacitinib Impurity 7N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2-chloro-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine
Tofacitinib Impurity 8N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine hydrochloride
Tofacitinib Impurity 93-((3R,4S)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile compound with 3-((3S,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile (1:1)
Tofacitinib Impurity 103-((3S,4S)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 11(3R,4S)-1-benzyl-N,4-dimethylpiperidin-3-amine dihydrochloride
Tofacitinib Impurity 12(3S,4R)-1-benzyl-N,4-dimethylpiperidin-3-amine dihydrochloride
Tofacitinib Impurity 13(3S,4S)-1-benzyl-N,4-dimethylpiperidin-3-amine dihydrochloride
Tofacitinib Impurity 14(3R,4R)-1-benzyl-N,4-dimethylpiperidin-3-amine dihydrochloride
Tofacitinib Impurity 153-((3R,4R)-3-(7H-[4,7'-bipyrrolo[2,3-d]pyrimidin]-4'-yl(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 16(3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidine-1-carbaldehyde
Tofacitinib Impurity 17N-methyl-N-((3R,4R)-4-methyl-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine
Tofacitinib Impurity 183,3'-((3R,3'R,4R,4'R)-3,3'-((7H-pyrrolo[2,3-d]pyrimidine-2,4-diyl)bis(methylazanediyl))bis(4-methylpiperidine-3,1-diyl))bis(3-oxopropanenitrile)
Tofacitinib Impurity 193-(4-(((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)(methyl)amino)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-3-oxopropanenitrile
Tofacitinib Impurity 203-((3R,4R)-3-((6,7-dihydro-5H-pyrrolo[2,3-d]pyrimidin-4-yl)(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile
Tofacitinib Impurity 21N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide
Tofacitinib Impurity 22(3R,4R)-1-(2-chloro-7H-pyrrolo[2,3-d]pyrimidin-4-yl)-N,4-dimethylpiperidin-3-amine hydrochloride
Tofacitinib Impurity 23(3R,4R)-N,4-dimethyl-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidin-3-amine
Tofacitinib Impurity 24N-((3R,4R)-1,4-dimethylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine hydrochloride
Tofacitinib Impurity 251-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)ethanone
Tofacitinib Impurity 26N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7-tosyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine compound with N-((3S,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7-tosyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine (1:1)
Tofacitinib Impurity 27N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7-tosyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine

 

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