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西格列汀杂质西他列汀杂质申报

磷酸西格列汀

西格列汀的药用形式为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）

别 名：磷酸西他列汀（一水合物）

化学名：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 状：白色到类白色结晶性非吸湿性粉末

溶解性：溶于水和DMF，微溶于甲醇，极微溶于乙醇、丙酮和乙腈。

适应症：

 西格列汀作为*上市的DPP-4抑制剂，拓展了降糖药物的选择领域，是优化糖尿病治疗策略的全新探索。西格列汀*的降糖疗效与安全性，以及该药改善胰岛β细胞功能的作用，将得到越来越多基础研究与临床试验的验证，无疑为糖尿病患者长期有效控制血糖带来了新希望。

单药治疗

本品配合饮食控制和运动，用于改善2 型糖尿病患者的血糖控制。

与二甲双胍联用

当单独使用盐酸二甲双胍血糖控制不佳时,可与盐酸二甲双胍联合使用，在饮食和运动基础上改善2 型糖尿病患者的血糖控制。

深圳远扬化学可提供西格列汀杂质西他列汀杂质申报所用全套杂质， 随货附CoA证书，HNMR，MS，HPLC图谱，纯度符合申报要求，西格列汀杂质西他列汀杂质为我司优势杂质，长期备有库存，发货快。如需西格列汀杂质西他列汀杂质相关详细信息，欢迎我司业务人员获取

附：西格列汀杂质西他列汀杂质申报 杂质列表：

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