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托法替尼申報(bào)用雜質(zhì)
枸櫞酸托法替尼背景及作用機(jī)理：
枸櫞酸托法替尼是由美國(guó)輝瑞制藥公司開(kāi)發(fā)一種治療類風(fēng)濕關(guān)節(jié)炎藥物，商品名Xeljanz，用于對(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。本產(chǎn)品是一種Janus激酶抑制劑，每日服用兩次。
2012年11月6日，美國(guó)食品藥品管理局(FDA)和輝瑞公司聯(lián)合宣布，枸櫞酸托法替尼獲準(zhǔn)用于對(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。
Xeljanz可作為單一治療或與氨甲喋呤或其他非生物疾病緩解性抗風(fēng)濕藥物(DMARD)聯(lián)合使用。該藥不應(yīng)與生物性DMARD或強(qiáng)免疫抑制劑(如硫唑嘌呤和環(huán)孢菌素)聯(lián)合使用。經(jīng)核準(zhǔn)的Xeljanz劑量為每日2次，每次5mg。
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(shū)，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~
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：托法替尼申報(bào)用雜質(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 | 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 | 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 |
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