托法替尼申報(bào)用雜質(zhì)

時(shí)間：2017/2/23閱讀：980

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輝瑞制藥公司開發(fā)一種治療類風(fēng)濕關(guān)節(jié)炎藥物，商品名Xeljanz，用于對氨甲喋呤治療應(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，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)勢雜質(zhì)，長期備有庫存，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)對照品外，我司還代理英國NIBSC標(biāo)準(zhǔn)品，美國劍橋CIL同位素標(biāo)準(zhǔn)品，美國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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