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托法替尼有哪些杂质？托法替尼原研药哪里买？

托法替尼的作用机理：

      托法替布（Tofacitinib，CP-690550）是辉瑞公司研发的一种新型口服JAK通路抑制剂。与当前多数其他RA治疗药物主要作用于细胞外靶点不同的是，托法替尼以细胞内信号转导通路为靶点，作用于细胞因子网络的核心部分。托法替布（tofacitinib）对JAK3的抑制强度是对JAK1及JAK2的5~100倍。托法替布是开发用于类风湿性关节炎治疗的*药物（first-in-class drug），FDA于2012年11月6日批准了JAK抑制剂tofacitinib用于治疗成人活动期及对甲氨蝶呤（MTX）反应不佳的中至重度类风湿关节炎（RA）患者. 
    FDA表示，中到重度的类风湿性关节炎病人，无法从常规口服治疗药物甲氨蝶呤（methotrexate）中获益或无法耐受治疗时，可使用辉瑞的新药Xeljanz(托法替尼)。托法替尼可单用，也可与甲氨蝶呤及其他特定的标准治疗药物合用。FDA批准Xeljanz一天两次、每次5毫克的使用剂量。但是同时指出，辉瑞还需提供更深入的数据支持一天两次、每次10毫克剂量的安全性。 

    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~

    杂质结构式及更多其他杂质对照品，欢迎进入我公司展台详细查询。

我司可供应托法替尼原研药/原研制剂Xeljanz
商品名（英）: Xeljanz
英文名：tofacitinib
通用名：托法替尼
规格：5mg 60片一瓶
类型：口服
制药公司：辉瑞
上市时间（美国FDA批准）：2012/11/6
用途：仅供科研实验使用。
适应症：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。

    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：托法替尼杂质列表：

Tofacitinib

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile

Tofacitinib Impurity 1

N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-1H-indol-4-amine

Tofacitinib Impurity 2

2-chloro-N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine

Tofacitinib Impurity 3

3-((3R,4R)-3-((2-chloro-7H-pyrrolo[2,3-d]pyrimidin-4-yl)(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile

Tofacitinib Impurity 4

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile

Tofacitinib Impurity 5

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxoprop*

Tofacitinib Impurity 6

3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoic acid

Tofacitinib Impurity 7

N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-2-chloro-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine

Tofacitinib Impurity 8

N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine hydrochloride

Tofacitinib Impurity 9

(3R,4S)-Tofacitinib with(3S,4R)-Tofacitinib

3-((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 10

(3S,4S)-Tofacitinib

3-((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 15

3-((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 17

N-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 18

3,3'-((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 19

3-(4-(((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)(methyl)amino)-7H-pyrrolo[2,3-d]pyrimidin-7-yl)-3-oxopropanenitrile

Tofacitinib Impurity 20

3-((3R,4R)-3-((6,7-dihydro-5H-pyrrolo[2,3-d]pyrimidin-4-yl)(methyl)amino)-4-methylpiperidin-1-yl)-3-oxopropanenitrile

Tofacitinib Impurity 21

N-((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 24

N-((3R,4R)-1,4-dimethylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine hydrochloride

Tofacitinib Impurity 25

1-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)ethanone

Tofacitinib Impurity 26

N-((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 27

N-((3R,4R)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7-tosyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine