Description

Dabigatran is a potent, competitive, and reversible direct thrombin inhibitor. This active pharmaceutical ingredient (API) is the key component in oral anticoagulant medications used to prevent and treat thromboembolic disorders. It is essential for pharmaceutical manufacturers developing anticoagulant therapies. The compound is identified by the CAS registry number 1246817-44-6.

Application

• Primary Pharmaceutical Ingredient: Core API for the production of oral anticoagulant drugs (e.g., Pradaxa®).
• Stroke Prevention: Used in medications for stroke prevention in patients with non-valvular atrial fibrillation.
• Venous Thromboembolism (VTE) Treatment: Formulated for the treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Post-Surgical Prophylaxis: Key component in drugs used to prevent blood clots following major orthopedic surgeries like hip or knee replacement.
• Research & Development: Serves as a critical reference standard and building block in cardiovascular and hematological research.
• Generic Drug Manufacturing: A vital raw material for companies producing bioequivalent generic versions of dabigatran etexilate.

Basic Information

Product Name	Dabigatran
CAS No.	1246817-44-6
Molecular Formula	C25H25N7O3
Molecular Weight	471.51 g/mol
Synonyms	BIBR 953; BIBR-953; Dabigatran free base; 3-[[2-[[[4-(Hexyloxycarbonylamino)iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-ylcarbonyl]pyridin-2-ylamino]propionic acid; Ethyl N-[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alaninate (non-salt form precursor)
EINECS	Contact for details

Quality Control

Our Dabigatran is manufactured under strict quality management systems, targeting high purity suitable for pharmaceutical applications. Quality is assured through comprehensive analytical testing including HPLC, NMR, and mass spectrometry. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure compliance with your specifications and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, 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 matches reference
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤1.0%
Heavy Metals	≤20 ppm

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