Description

Dabigatran Ethyl Acoh Salt is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) salt form. It is the key precursor in the synthesis of Dabigatran Etexilate, a direct thrombin inhibitor used as an oral anticoagulant. This compound is essential for pharmaceutical manufacturers and research institutions developing and producing next-generation anticoagulant therapies. Its consistent quality and purity are critical for ensuring the safety and efficacy of the final drug product.

Application

• Primary Pharmaceutical Intermediate: For the synthesis of Dabigatran Etexilate, the active ingredient in anticoagulant medications.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a direct input in the production of finished dosage forms under Good Manufacturing Practice (GMP) conditions.
• Research & Development: Used in pharmacological studies, bioavailability research, and the development of new anticoagulant formulations.
• Analytical Reference Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods.
• Process Chemistry & Scale-Up: Critical for process optimization and scaling from laboratory to commercial production batches.

Basic Information

Product Name	Dabigatran Ethyl Acoh Salt
CAS No.	429658-95-7
Molecular Formula	C25H25N7O3 • C2H6O
Molecular Weight	627.69 g/mol
Synonyms	Dabigatran Ethanolate; BIBR 953 ZW Ethanolate; Ethyl 3-[(2-{[(4-{[(hexyloxy)carbonyl]amino}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino]propanoate ethanolate; Dabigatran Ethyl Alcoholate; Dabigatran Ethanol Solvate; BIBR-953 Ethanolate
EINECS	Contact for details

Quality Control

Our Dabigatran Ethyl Acoh Salt is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality is assured through a comprehensive battery of analytical tests including HPLC for purity, residual solvent analysis, and identification by IR and NMR. A Certificate of Analysis (COA) is provided with each batch, detailing all specifications and results. Our quality management system supports compliance with cGMP, ICH Q7, and other relevant regulatory guidelines for API 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 original container should be kept sealed in a desiccator when not in use.

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)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% 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.