Dabigatran Etexilate Mesylate|甲磺酸达比加群酯|872728-81-9

产品描述

等级：活性药物成分（API）

化学名称：N-[[2-[[[4-[[[[（己氧基）羰基]氨基亚甲基]苯基]氨基]甲基]-1-甲基- 1h -苯并咪唑-5- y

分子式：C35H45N7O8S

分子量：723.839

规格：EP，根据ChP/USP/EP建立的企业标准

外观：粉末

总杂质：不超过0.5%

纯度：不低于99%

残留溶剂：完全符合ICH Q3C要求

致突变杂质：完全符合ICH M8

亚硝胺评估：可用

粒度：普通级或研磨/筛分根据客户的要求。

储存：室温

生产能力：商用

标准包装：1kg/袋，5kg/袋，或根据客户要求

产品用途

达比加群是一种抗凝剂，用于治疗和预防房颤患者的血栓和中风。具体来说，它用于预防髋关节或膝关节置换术后的血栓形成，以及先前有血栓病史的患者。它被用作华法林的替代品，不需要通过血液测试进行监测。在7项不同研究的荟萃分析中，达比加群在预防缺血性卒中方面没有优于华法林；然而，与华法林相比，达比加群颅内出血的风险较低，但与华法林相比，其胃肠道出血的风险也较高。它是口服的。

常见的副作用包括出血和胃炎。其他副作用可能包括脊柱周围出血和过敏反应，如过敏反应。在严重出血的情况下，可以用解毒剂idarucizumab逆转。不建议在怀孕或哺乳期间使用。与华法林相比，它与其他药物的相互作用更少。它是一种直接凝血酶抑制剂。

达比加群于2010年在美国被批准用于医疗用途。它被列入世界卫生组织的基本药物清单。2020年，它是美国第306种最常用的处方药，处方数量超过100万。达比加群是一种通用药物。

联系方式

四川青木制药有限公司

四川省眉山市东坡区经济开发区东区顺江大道南段55号

国际营销部(International):

Email: sales@eastonpharma.cn 

Tel: 028-87827187

国内营销部(Mainland)：

李经理 13880480517   

杨经理 15982276454

Product Description

• Grade: Active Pharmaceutical Ingredient(API)

• Chemical Name: N-[[2-[[[4-[[[(HEXYLOXY)CARBONYL]AMINO]IMINOMETHYL]PHENYL]AMINO]METHYL]-1-METHYL-1H-BENZIMIDAZOL-5-Y

• Molecular Formula: C35H45N7O8S

• Molecular Weight:723.839

• Specification: EP, Enterprise Standard established according to      ChP/USP/EP

• Appearance: Powder

• Total impurities: not more than 0.5%

• Purity: not less than 99%

• Residual Solvents: fully comply with ICH Q3C

• Mutagenic impurities: fully comply with ICH M8

• Nitrosamine assessment: available

• Particle size: regular grade or milling/sieving according      to customer’s requirement.

• Storage: Room temperature

• Production capacity: Commercial

• Standard Package: 1kg/bag, 5kg/bag, or according to the      customer’s requirement

Applications 

• Dabigatran, sold under the brand      name Pradaxa among others, is an anticoagulant used to      treat and prevent blood clots and stroke in people      with atrial fibrillation. Specifically, it is used to prevent      blood clots following hip or knee replacement and in      those with a history of prior clots. It is used as an alternative      to warfarin and does not require monitoring by blood      tests. In a meta-analysis of 7 different studies, there was no      benefit of dabigatran over warfarin in preventing ischemic stroke;      however, dabigatran was associated with a lower hazard for intracranial      bleeding compared with warfarin but also had a higher risk of      gastrointestinal bleeding relative to warfarin. It is taken by mouth.

• Common side effects include bleeding      and gastritis. Other side effects may include bleeding      around the spine and allergic reactions such      as anaphylaxis. In cases of severe bleeding, it can be reversed      with the antidote, idarucizumab. Use is not recommended      during pregnancy or breastfeeding. Compared to      warfarin it has fewer interactions with other medications. It is      a direct thrombin inhibitor.

• Dabigatran was approved for medical use in the      United States in 2010. It is on the World Health Organization’s      List of Essential Medicines. In 2020, it was the 306th most commonly      prescribed medication in the United States, with more than 1 million      prescriptions. Dabigatran is available as a generic medication.

Contact Information

Sichuan Qingmu Pharmaceutical Co., Ltd.

Add: No. 55, South Shunjiang Avenue, East Economic Development Zone, Dongpo District, Meishan City, Sichuan, 620036, China

International Marketing Department: 

Email: sales@eastonpharma.cn 

Tel: 0086-28-87827187