托法替尼有哪些雜質(zhì)？托法替尼原研藥哪里買？

托法替尼的作用機(jī)理：

      托法替布（Tofacitinib，CP-690550）是輝瑞公司研發(fā)的一種新型口服JAK通路抑制劑。與當(dāng)前多數(shù)其他RA治療藥物主要作用于細(xì)胞外靶點(diǎn)不同的是，托法替尼以細(xì)胞內(nèi)信號(hào)轉(zhuǎn)導(dǎo)通路為靶點(diǎn)，作用于細(xì)胞因子網(wǎng)絡(luò)的核心部分。托法替布（tofacitinib）對(duì)JAK3的抑制強(qiáng)度是對(duì)JAK1及JAK2的5~100倍。托法替布是開(kāi)發(fā)用于類風(fēng)濕性關(guān)節(jié)炎治療的*藥物（first-in-class drug），F(xiàn)DA于2012年11月6日批準(zhǔn)了JAK抑制劑tofacitinib用于治療成人活動(dòng)期及對(duì)甲氨蝶呤（MTX）反應(yīng)不佳的中至重度類風(fēng)濕關(guān)節(jié)炎（RA）患者. 
    FDA表示，中到重度的類風(fēng)濕性關(guān)節(jié)炎病人，無(wú)法從常規(guī)口服治療藥物甲氨蝶呤（methotrexate）中獲益或無(wú)法耐受治療時(shí)，可使用輝瑞的新藥Xeljanz(托法替尼)。托法替尼可單用，也可與甲氨蝶呤及其他特定的標(biāo)準(zhǔn)治療藥物合用。FDA批準(zhǔn)Xeljanz一天兩次、每次5毫克的使用劑量。但是同時(shí)指出，輝瑞還需提供更深入的數(shù)據(jù)支持一天兩次、每次10毫克劑量的安全性。 

    深圳遠(yuǎn)揚(yáng)化學(xué)可提供托法替尼申報(bào)所用全套雜質(zhì)， 隨貨附CoA證書，HNMR，MS，HPLC圖譜，純度符合申報(bào)要求，托法替尼雜質(zhì)為我司優(yōu)勢(shì)雜質(zhì)，長(zhǎng)期備有庫(kù)存，發(fā)貨快。如需托法替尼雜質(zhì)相關(guān)詳細(xì)信息，歡迎我司業(yè)務(wù)人員獲取~

    雜質(zhì)結(jié)構(gòu)式及更多其他雜質(zhì)對(duì)照品，歡迎進(jìn)入我公司展臺(tái)詳細(xì)查詢。

我司可供應(yīng)托法替尼原研藥/原研制劑Xeljanz
商品名（英）: Xeljanz
英文名：tofacitinib
通用名：托法替尼
規(guī)格：5mg 60片一瓶
類型：口服
制藥公司：輝瑞
上市時(shí)間（美國(guó)FDA批準(zhǔn)）：2012/11/6
用途：僅供科研實(shí)驗(yàn)使用。
適應(yīng)癥：對(duì)氨甲喋呤治療應(yīng)答不充分或不耐受的中至重度活動(dòng)性類風(fēng)濕關(guān)節(jié)炎(RA)成人患者。

    除自主品牌雜質(zhì)對(duì)照品外，我司還代理英國(guó)NIBSC標(biāo)準(zhǔn)品，美國(guó)劍橋CIL同位素標(biāo)準(zhǔn)品，美國(guó)NIST標(biāo)準(zhǔn)物質(zhì)，歐洲標(biāo)準(zhǔn)局IRMM標(biāo)準(zhǔn)物質(zhì)，加拿大TRC標(biāo)準(zhǔn)品，TLC標(biāo)準(zhǔn)品，MOLCAN標(biāo)準(zhǔn)品，NRC標(biāo)準(zhǔn)品等，歡迎洽談。

附：托法替尼雜質(zhì)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