西格列汀雜質西他列汀雜質申報

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：磷酸西格列汀（一水合物）（中文）、Sitagliptin phosphate monohydrate（英文）

別 名：磷酸西他列汀（一水合物）

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域，是優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合使用，在飲食和運動基礎上改善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西他列汀雜質申報所用全套雜質， 隨貨附CoA證書，HNMR，MS，HPLC圖譜，純度符合申報要求，西格列汀雜質西他列汀雜質為我司優勢雜質，長期備有庫存，發貨快。如需西格列汀雜質西他列汀雜質相關詳細信息，歡迎我司業務人員獲取

附：西格列汀雜質西他列汀雜質申報 雜質列表：

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