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Postion:Product Catalog >API>Blood System Drugs>Anticoagulant and Antiplatelet Drugs>Dabigatran etexilate mesylate
Dabigatran etexilate mesylate
  • Dabigatran etexilate mesylate
  • Dabigatran etexilate mesylate
  • Dabigatran etexilate mesylate
  • Dabigatran etexilate mesylate
  • Dabigatran etexilate mesylate

Dabigatran etexilate mesylate

Price $1
Package 1kg
Min. Order: 1kg
Supply Ability: 10000
Update Time: 2025-07-22

Product Details

Product Name: Dabigatran etexilate mesylate CAS No.: 211914-51-1
Min. Order: 1kg Purity: 99%
Supply Ability: 10000 Release date: 2025/07/22

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Property Description

Chemical Name:Dabigatran etexilate mesylate

 CAS:211914-51-1

Synonyms:BIBR 1048 mesylate; Pradaxa (brand name)

Molecular Formula:C??H??N?O? · CH?O?S

Molecular Weight:723.85 g/mol (salt form)

Appearance:White to off-white powder

Solubility:Slightly soluble in water; soluble in methanol and dimethyl sulfoxide (DMSO)

Melting Point:~120–125 °C (decomposes)

pKa:~4 (protonated amine), ~13 (ester group)

Partition Coefficient (LogP) ~3.3 (lipophilic)

Stability:Stable under recommended storage conditions (2–8°C, dry place)

Pharmacological Class:Direct thrombin inhibitor (anticoagulant)

Mechanism of Action:Inhibits free and clot-bound thrombin, preventing fibrin formation

Primary Use:Prevention of stroke and systemic embolism in atrial fibrillation; treatment/prevention of venous thromboembolism (VTE)

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Test ParameterSpecificationMethod (Commonly Used)
AppearanceWhite to off-white powderVisual inspection (EP/JP/USP)
IdentificationComplies with reference standard (e.g., IR, HPLC retention time, mass spec)HPLC, FTIR, MS
Assay (Purity)98.0%–102.0% (w/w) of dabigatran etexilate mesylateHPLC (RP-HPLC, UV detection)
Water Content≤ 1.0% (Karl Fischer titration)Karl Fischer titration
Residual SolventsMeets ICH Q3C limits (e.g., methanol ≤ 3000 ppm, DMSO ≤ 500 ppm)GC (Gas Chromatography)
Heavy Metals≤ 20 ppm (as per ICH Q3D)ICP-MS / AAS
Related SubstancesIndividual impurities: ≤ 0.5%
Total impurities: ≤ 1.5%
HPLC (gradient method)
Particle SizeAs per manufacturer’s specification (e.g., D90 ≤ 100 μm for tablet formulation)Laser diffraction
Dissolution≥ 80% dissolved in 30 min (pH-dependent, e.g., pH 1.2, 4.5, 6.8)USP Apparatus I/II
Microbial LimitsTotal aerobic count: ≤ 103 CFU/g
Pathogens: Absent (Salmonella, E. coli, etc.)
Microbial enumeration (USP <61>, <62>)
Melting Point~120–125°C (with decomposition)Differential Scanning Calorimetry (DSC)
pH (1% Solution)3.0–5.0Potentiometric method
Specific Optical Rotation+50° to +60° (if applicable)Polarimetry

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Company Profile Introduction

Wuhan Hao Rong Biotechnology Co., Ltd., located in East Lake high tech Development Zone, Wuhan, is a company specializing in the production and operation of chemical raw materials, flavors and fragrances, food additives, agrochemicals and other products. The company has first-class production equipment, advanced production technology, scientific management system, perfect detection means, and an excellent R & D team. The R & D center of the company has a technical team specialized in research and development, as well as a number of advanced detection, experiment and pilot equipment, and has established a good technical support relationship with a number of scientific research institutions, with strong technical force. The company has a wide range of products, in line with the quality of survival, service and development, customer-centric, integrity management philosophy, do our best to provide customers with quality and cheap raw materials. In addition, haorong also helps customers develop and implement customized system solutions. In these core areas of the chemical industry, haorong's core expertise covers chemicals and application technology, flexible asset management and customized services.

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  • Since: 2019-11-21
  • Address: Room E020, 4th Floor (1-3), Building 5, International Enterprise Center, No.1 Guanshan Second Road,
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