Product Details
| Product Name: Dabigatran etexilate mesylate | CAS No.: 211914-51-1 |
| Min. Order: 1kg | Purity: 99% |
| Supply Ability: 10000 | Release date: 2025/10/13 |
Property Description
Chemical Name：Dabigatran etexilate mesylate
CAS:211914-51-1
Synonyms：BIBR 1048 mesylate; Pradaxa (brand name)
Molecular Formula：C₃₄H₄₁N₇O₅ · CH₄O₃S
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)
| Test Parameter | Specification | Method (Commonly Used) |
|---|---|---|
| Appearance | White to off-white powder | Visual inspection (EP/JP/USP) |
| Identification | Complies 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 mesylate | HPLC (RP-HPLC, UV detection) |
| Water Content | ≤ 1.0% (Karl Fischer titration) | Karl Fischer titration |
| Residual Solvents | Meets 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 Substances | - Individual impurities: ≤ 0.5% - Total impurities: ≤ 1.5% | HPLC (gradient method) |
| Particle Size | As 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 Limits | - Total 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) | 3.0–5.0 | Potentiometric method |
| Specific Optical Rotation | +50° to +60° (if applicable) | Polarimetry |
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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China- Since: 2019-11-21
- Address: Room E020, 4th Floor (1-3), Building 5, International Enterprise Center, No.1 Guanshan Second Road,
INQUIRY
Ashley
+8618565342920
sales@chembj.net
+8618565342920
sales@chembj.net