達比加群酯雜質新藥申報用

時間：2017/2/24閱讀：1183

達比加群酯是zui前沿的新一代口服抗凝藥物直接凝血酶抑制劑(DTIs)，用于預防非瓣膜性房顫患者的卒中和全身性栓塞。達比加群酯可提供有效的、可預測的、穩(wěn)定的抗凝效果，同時較少發(fā)生藥物相互作用，無藥物食物相互作用，無需常規(guī)進行凝血功能監(jiān)測或劑量調整。

深圳遠揚化學可提供達比加群酯申報所用全套雜質，進口國產均有銷售，隨貨附CoA證書，HNMR，MS，HPLC圖譜，純度符合申報要求。另外，我司有自主實驗室，可提供達比加群酯雜質定制服務，如以上列表無您需要的雜質，我司詳詢（請點擊本頁標題下方，進入該公司展臺查看我司信息）。

Dabigatran	3-(2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid	C25H25N7O3	471.51
Dabigatran Impurity 1	ethyl 3-(2-(iminomethyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C20H21N5O3	379.41
Dabigatran Impurity 2	3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid	C32H37N7O5	599.68
Dabigatran Impurity 3	ethyl 3-(1-methyl-3-oxo-N-(pyridin-2-yl)-1,2,3,4-tetrahydroquinoxaline-6-carboxamido)propanoate	C20H22N4O4	382.41
Dabigatran Impurity 4	methyl 3-(2-(hydroxymethyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C19H20N4O4	368.39
Dabigatran Impurity 5	3-(2-(chloromethyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid	C18H17ClN4O3	372.81
Dabigatran Impurity 6	diethyl 3,3'-((2,2'-(oxybis(methylene))bis(1-methyl-1H-benzo[d]imidazole-5,5'-carbonyl))bis(pyridin-2-ylazanediyl))dipropanoate	C40H42N8O7	746.32
Dabigatran Impurity 7	hexyl (imino(4-(((1-methyl-5-(pyridin-2-ylcarbamoyl)-1H-benzo[d]imidazol-2-yl)methyl)amino)phenyl)methyl)carbamate	C29H33N7O3	527.62
Dabigatran Impurity 8	(Z)-3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoic acid	C32H37N7O5	599.68
Dabigatran Impurity 9	ethyl 3-(2-(((4-(((hexyloxy)carbonyl)carbamoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C34H40N6O6	628.72
Dabigatran Impurity 10	(Z)-ethyl 3-(2-(((4-(N'-((hexan-2-yloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C34H41N7O5	627.73
Dabigatran Impurity 11	(Z)-ethyl 3-(2-(((4-(N'-((hexan-3-yloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C34H41N7O5	627.73
Dabigatran Impurity 12	ethyl 3-(1,2-dimethyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C20H22N4O3	366.41
Dabigatran Impurity 13	ethyl 3-(1-methyl-2-oxo-N-(pyridin-2-yl)-2,3-dihydro-1H-benzo[d]imidazole-5-carboxamido)propanoate	C19H20N4O4	368.39
Dabigatran Impurity 14	(Z)-ethyl 2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carboxylate	C26H33N5O4	479.57
Dabigatran Impurity 15	ethyl 3-(2-(((4-cyanophenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C27H26N6O3	482.53
Dabigatran Impurity 16	ethyl 3-(2-(((4-(ethoxy(imino)methyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate hydrochloride	C29H32N6O4·HCl	565.06
Dabigatran Impurity 17	(Z)-methyl 3-(2-(((4-(N'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C33H39N7O5	613.71
Dabigatran Impurity 18	(Z)-hexyl (amino(4-(((5-((3-amino-3-oxopropyl)(pyridin-2-yl)carbamoyl)-1-methyl-1H-benzo[d]imidazol-2-yl)methyl)amino)phenyl)methylene)carbamate	C32H38N8O4	598.70
Dabigatran Impurity 19	ethyl 3-(2-(((4-carbamoylphenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate	C27H28N6O4	500.55
Dabigatran Impurity 20	ethyl 3-(2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate hydrochloride	C27H29N7O3·HCl	536.03
Dabigatran Impurity 21	ethyl 3-(3-amino-4-(methylamino)-N-(pyridin-2-yl)benzamido)propanoate	C18H22N4O3	342.39
Dabigatran Impurity 22	ethyl 3-(3-(2-((4-cyanophenyl)amino)acetamido)-4-(methylamino)-N-(pyridin-2-yl)benzamido)propanoate	C27H28N6O4	500.55

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