Description

Dabigatran Etexilate CAS NO 211915-06-9 is a direct thrombin inhibitor prodrug, representing a significant advancement in oral anticoagulant therapy. Its primary commercial value lies in its predictable pharmacokinetic profile, which reduces the need for routine coagulation monitoring compared to traditional therapies. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing anticoagulant medications targeting the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as the treatment and prevention of deep vein thrombosis and pulmonary embolism.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of novel oral anticoagulant (NOAC) medications.
• Stroke Prevention: Manufacture of drugs used for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
• Venous Thromboembolism (VTE) Treatment: Core component in anticoagulants for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• VTE Prophylaxis: Used in drugs for the primary prevention of venous thromboembolic events in patients who have undergone elective total hip or knee replacement surgery.
• Research & Development: Critical reference standard and building block in cardiovascular and hematological research for developing next-generation antithrombotic agents.
• Generic Drug Manufacturing: Sourcing of high-purity API for the production of bioequivalent generic versions of branded anticoagulant drugs following patent expiry.

Basic Information

Product Name	Dabigatran Etexilate
CAS No.	211915-06-9
Molecular Formula	C34H41N7O5
Molecular Weight	627.74 g/mol
Synonyms	Dabigatran Etexilate Mesylate; BIBR 1048; BIBR-1048; Dabigatran Etexilate Methanesulfonate; Ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-2-pyridinyl-β-alaninate; Pradaxa (Brand Name API); Dabigatran Etexilate Monomesylate
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical API applications. Quality is assured through rigorous in-process and final release testing, including identity confirmation, purity assay, and control of specified impurities. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results against agreed specifications. Our quality systems are designed to support customer requirements for GMP compliance and regulatory filings (e.g., DMF, CEP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Particle Size Distribution	Contact for details

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