Description

Dabigatran Etexilate Benzenesulfonate is a key pharmaceutical intermediate and the active pharmaceutical ingredient (API) of the direct thrombin inhibitor, dabigatran etexilate mesylate. This compound is critical for the synthesis of novel oral anticoagulant (NOAC) medications used to prevent stroke and systemic embolism. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the development and production of advanced anticoagulant therapies. Consistent quality and reliable supply are paramount for ensuring the safety and efficacy of the final drug product.

Application

• Active Pharmaceutical Ingredient (API) Synthesis: Primary intermediate in the commercial manufacturing of Dabigatran Etexilate Mesylate, the API for Pradaxa®.
• Pharmaceutical Research & Development: Used in preclinical and clinical studies for developing new anticoagulant formulations and generics.
• Process Chemistry & Scale-Up: Serves as a critical building block for process optimization and pilot-scale production in CDMO facilities.
• Reference Standard: Employed as a high-purity analytical standard for quality control and regulatory testing in pharmaceutical labs.
• Drug Product Formulation Development: Utilized in studies focusing on the stability, bioavailability, and final dosage form development of dabigatran-based drugs.

Basic Information

Product Name	Dabigatran Etexilate Benzenesulfonate
CAS No.	1019206-65-5
Molecular Formula	C34H41N7O5 • C6H6O3S
Molecular Weight	723.85 g/mol
Synonyms	Dabigatran Etexilate Besylate; BIBR 1048 Benzenesulfonate; Ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-2-pyridinyl-β-alaninate benzenesulfonate; Dabigatran Etexilate BS; Dabigatran Etexilate Benzenesulphonate; Dabigatran Etexilate Benzenesulfonic Acid Salt
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Benzenesulfonate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and impurity profiles, 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. We support compliance with cGMP, ISO, and other relevant regulatory standards for pharmaceutical intermediates.

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 under dry, inert conditions to maintain stability and prevent degradation. The storage area should be well-ventilated and separate from incompatible materials.

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%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤1.0%
Heavy Metals	≤20 ppm

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