
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 |
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)
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 |
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- Since: 2019-11-21
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