Description

Dabigatran Etexilate Tetrahydrate is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is the tetrahydrate salt form of the direct thrombin inhibitor prodrug, which is critical for the synthesis of advanced anticoagulant medications. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of novel oral anticoagulant (NOAC) therapies, where consistent quality and reliable supply are paramount.

Application

• Active Pharmaceutical Ingredient (API) for the manufacture of finished dosage forms of direct thrombin inhibitor anticoagulants.
• Pharmaceutical Intermediate in the synthesis of Dabigatran Etexilate mesylate, the active drug substance in commercial medications.
• Reference Standard for quality control and analytical method development in pharmaceutical laboratories.
• Research & Development of new anticoagulant therapies and drug delivery systems in academic and institutional settings.
• Process Development for scaling up production and optimizing synthetic routes in API manufacturing.
• Regulatory Submissions, providing high-purity material for stability studies and clinical trial batch production.

Basic Information

Product Name	Dabigatran Etexilate Tetrahydrate
CAS No.	916327-75-8
Molecular Formula	C34H41N7O5 • 4H2O
Molecular Weight	723.85 g/mol (Tetrahydrate)
Synonyms	BIBR 1048 Tetrahydrate; Dabigatran Etexilate Hydrate; Ethyl N-[(2-{[(4-{N'-[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl]-N-2-pyridinyl-β-alaninate tetrahydrate; BIBR-1048 Tetrahydrate; Dabigatran Etexilate (Tetrahydrate); Dabigatranetexilat Tetrahydrate; Pradaxa Intermediate
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Tetrahydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profile. Certificates of Analysis (COA) are provided, detailing results from HPLC, NMR, and other relevant pharmacopeial methods. We support compliance with cGMP, ICH Q7, and other relevant regulatory guidelines for API manufacturing.

Storage

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

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% (on anhydrous basis)
Water Content (KF)	9.0% - 11.0% (Theoretical for Tetrahydrate: ~10.0%)
Related Substances (HPLC)	Total impurities ≤2.0%; Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤20 ppm

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