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托法替尼有哪些雜質(zhì)?托法替尼原研藥哪里買?

時間:2016/6/14閱讀:4472
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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。與當前多數(shù)其他RA治療藥物主要作用于細胞外靶點不同的是,托法替尼以細胞內(nèi)信號轉導通路為靶點,作用于細胞因子網(wǎng)絡的核心部分。托法替布(tofacitinib)對JAK3的抑制強度是對JAK1及JAK2的5~100倍。托法替布是開發(fā)用于類風濕性關節(jié)炎治療的*藥物(first-in-class drug),F(xiàn)DA于2012年11月6日批準了JAK抑制劑tofacitinib用于治療成人活動期及對甲氨蝶呤(MTX)反應不佳的中至重度類風濕關節(jié)炎(RA)患者. 
    FDA表示,中到重度的類風濕性關節(jié)炎病人,無法從常規(guī)口服治療藥物甲氨蝶呤(methotrexate)中獲益或無法耐受治療時,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準治療藥物合用。FDA批準Xeljanz一天兩次、每次5毫克的使用劑量。但是同時指出,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)相關詳細信息,歡迎我司業(yè)務人員獲取~

    雜質(zhì)結構式及更多其他雜質(zhì)對照品,歡迎進入我公司展臺詳細查詢。

我司可供應托法替尼原研藥/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
上市時間(美國FDA批準):2012/11/6
用途:僅供科研實驗使用。
適應癥: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節(jié)炎(RA)成人患者。

    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

 

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