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西格列汀雜質(zhì)西他列汀雜質(zhì)申報

時間:2016/6/28閱讀:2425
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西格列汀雜質(zhì)西他列汀雜質(zhì)申報

磷酸西格列汀

西格列汀的藥用形式為磷酸西格列汀一水合物。

通用名:磷酸西格列?。ㄒ凰衔铮ㄖ形模itagliptin phosphate monohydrate(英文)

別 名:磷酸西他列?。ㄒ凰衔铮?/span>

化學名:7-[(3R)-3-ami-oxo-4-(2,4,5trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate

分子式:C16H15F6N5O·H3PO4·H2O

分子量:523.32

性 狀:白色到類白色結(jié)晶性非吸濕性粉末

溶解性:溶于水和DMF,微溶于甲醇,極微溶于乙醇、丙酮和乙腈。

 

適應(yīng)癥:

 西格列汀作為*上市的DPP-4抑制劑,拓展了降糖藥物的選擇領(lǐng)域,是優(yōu)化糖尿病治療策略的全新探索。西格列汀*的降糖療效與安全性,以及該藥改善胰島β細胞功能的作用,將得到越來越多基礎(chǔ)研究與臨床試驗的驗證,無疑為糖尿病患者長期有效控制血糖帶來了新希望。

單藥治療

本品配合飲食控制和運動,用于改善2 型糖尿病患者的血糖控制。

與二甲雙胍聯(lián)用

當單獨使用鹽酸二甲雙胍血糖控制不佳時,可與鹽酸二甲雙胍聯(lián)合使用,在飲食和運動基礎(chǔ)上改善2 型糖尿病患者的血糖控制。

 

深圳遠揚化學可提供西格列汀雜質(zhì)西他列汀雜質(zhì)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,西格列汀雜質(zhì)西他列汀雜質(zhì)為我司優(yōu)勢雜質(zhì),長期備有庫存,發(fā)貨快。如需西格列汀雜質(zhì)西他列汀雜質(zhì)相關(guān)詳細信息,歡迎我司業(yè)務(wù)人員獲取

 

附:西格列汀雜質(zhì)西他列汀雜質(zhì)申報 雜質(zhì)列表:

Sitagliptin

(R)-3-ami-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one

Sitagliptin Impurity 1

(R)-3-((tert-butoxycarbonyl)amino)-4-(3,4-difluorophenyl)butanoic acid

Sitagliptin Impurity 2

(R)-3-((tert-butoxycarbonyl)amino)-4-(2,4-difluorophenyl)butanoic acid

Sitagliptin Impurity 3

(R)-3-((tert-butoxycarbonyl)amino)-4-(2,5-difluorophenyl)butanoic acid

Sitagliptin Impurity 4

(S)-Sitagliptin N-Boc-Acid Impurity

(S)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoic acid

Sitagliptin Impurity 5

(R)-Sitagliptin N-Boc-Methyl-Ester Impurity

(R)-methyl 3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoate

Sitagliptin Impurity 6

(R)-Sitagliptin Methyl-Ester Impurity

(R)-methyl 3-amino-4-(2,4,5-trifluorophenyl)butanoate

Sitagliptin Impurity 7

2-Desfluoro Sitagliptin

(R)-3-amino-4-(3,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one

Sitagliptin Impurity 8

5-Desfluoro Sitagliptin

(R)-3-amino-4-(2,4-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one

Sitagliptin Impurity 9

4-Desfluoro Sitagliptin

(R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one

Sitagliptin Impurity 10

(R)-Sitagliptin N-Boc-Acid Impurity

(R)-3-((tert-butoxycarbonyl)amino)-4-(2,4,5-trifluorophenyl)butanoic acid

Sitagliptin Impurity 11

Sitagliptin N-Boc Impurity

(R)-tert-butyl (4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)carbamate

Sitagliptin Impurity 12

Sitagliptin (S)-Isomer

(S)-3-ami-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one

Sitagliptin Impurity 13

Sitagliptin Ketoamide Impurity

1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butane-1,3-dione

Sitagliptin Impurity 14

Sitagliptin Enamine Impurity

(Z)-3-ami-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-2-en-1-one

Sitagliptin Impurity 15

Sitagliptin Acid Impurity

(R)-3-amino-4-(2,4,5-trifluorophenyl)butanoic acid

Sitagliptin Impurity 16

3-Desamino-2,3-dehydro Sitagliptin

(E)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-2-en-1-one

Sitagliptin Impurity 17

3-Desamino-3,4-dehydro Sitagliptin

(E)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)but-3-en-1-one

 

 

 

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