Description

Dabigatran Etexilate Mesylate is the mesylate salt form of the direct thrombin inhibitor prodrug, dabigatran etexilate. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished anticoagulant medications. It is primarily required by pharmaceutical manufacturers engaged in the research, development, and commercial production of oral anticoagulant therapies.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of oral anticoagulant capsules and tablets.
• Reference Standard in analytical laboratories for quality control and method validation.
• Pharmaceutical Research & Development for studying pharmacokinetics, metabolism, and new drug delivery systems.
• Generic Drug Manufacturing for producing bioequivalent versions of branded anticoagulant products.
• Clinical Trial Material supply for Phase I-III studies of thrombin inhibitor therapies.

Basic Information

Product Name	Dabigatran Etexilate Mesylate
CAS No.	872728-81-9
Molecular Formula	C34H41N7O5 • CH4O3S
Molecular Weight	723.86 g/mol
Synonyms	Dabigatran Etexilate Methanesulfonate; BIBR 1048 MS; Dabigatran Etexilate Mesilate; (3-{[(2-{[(4-{[(Hexyloxy)carbonyl]amino}phenyl)carbonyl]amino}-5-{[N-(pyridin-2-yl)-β-alanyl]amino}phenyl)carbonyl]pyridin-2-ylamino}propyl)ethyl ester methanesulfonate; BIBR-1048 Mesylate; Dabigatranetexilat Mesilate; Dabigatran Etexilate Mesylate Salt
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate Mesylate is manufactured under strict quality management systems. Each batch is tested to ensure compliance with relevant pharmacopeial standards (such as USP/EP) and internal specifications for identity, purity, and potency. A comprehensive Certificate of Analysis (COA) documenting all test results is provided with every shipment to guarantee traceability and regulatory compliance for our global pharmaceutical partners.

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 in a dry environment to maintain stability and purity.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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