托法替尼申報用雜質(zhì)

時間：2017/2/23閱讀：965

枸櫞酸托法替尼背景及作用機理：

枸櫞酸托法替尼是由美國輝瑞制藥公司開發(fā)一種治療類風濕關(guān)節(jié)炎藥物，商品名Xeljanz，用于對氨甲喋呤治療應答不充分或不耐受的中至重度活動性類風濕關(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用于對氨甲喋呤治療應答不充分或不耐受的中至重度活動性類風濕關(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濕藥物(DMARD)聯(lián)合使用。該藥不應與生物性DMARD或強免疫抑制劑(如硫唑嘌呤和環(huán)孢菌素)聯(lián)合使用。經(jīng)核準的Xeljanz劑量為每日2次，每次5mg。

深圳遠揚化學可提供托法替尼申報所用全套雜質(zhì)，隨貨附CoA證書，HNMR，MS，HPLC圖譜，純度符合申報要求，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)詳細信息，歡迎我司業(yè)務人員獲取~

除自主品牌雜質(zhì)對照品外，我司還代理英國NIBSC標準品，美國劍橋CIL同位素標準品，美國NIST標準物質(zhì)，歐洲標準局IRMM標準物質(zhì)，加拿大TRC標準品，TLC標準品，MOLCAN標準品，NRC標準品等，歡迎洽談。

附：托法替尼申報用雜質(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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