Description

Dabigatran Etexilate Mesylate is the mesylate salt form of the prodrug Dabigatran Etexilate, a direct thrombin inhibitor. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of anticoagulant medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of novel oral anticoagulants (NOACs) for the prevention of stroke and systemic embolism.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of finished dosage forms (e.g., capsules) for anticoagulant therapy.
• Reference Standard: Used as a certified reference material in analytical laboratories for quality control and method validation.
• Research & Development: Critical for preclinical and clinical studies investigating thrombosis, coagulation pathways, and new cardiovascular treatments.
• Generic Drug Manufacturing: Serves as the key starting material for companies producing generic versions of direct thrombin inhibitor medications.
• Formulation Development: Utilized in stability studies, excipient compatibility testing, and the development of novel drug delivery systems.

Basic Information

Product Name	Dabigatran Etexilate Mesylate
CAS No.	593282-20-3
Molecular Formula	C34H41N7O5 · CH4O3S
Molecular Weight	723.82 g/mol
Synonyms	Dabigatran Etexilate Methanesulfonate; BIBR 1048 MS; BIBR-1048MS; (3-{[(2-{[(4-{[(Hexyloxy)carbonyl]amino}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propyl)ethylcarbamate methanesulfonate; Ethyl N-[(2-{[4-({[(hexyloxy)carbonyl]amino}iminomethyl)phenyl]amino}methyl)-1-methyl-1H-benzimidazol-5-yl]-N-(pyridin-2-yl)-β-alaninate methanesulfonate
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Mesylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.