Description

Dabigatran Etexilate n-Oxide is a key pharmaceutical intermediate and a specific oxidative metabolite of the direct thrombin inhibitor, dabigatran etexilate. This compound is of significant importance for analytical research, method development, and quality control within the pharmaceutical industry. It is primarily utilized by research institutions and pharmaceutical manufacturers involved in the development, production, and bioanalytical monitoring of anticoagulant therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of oxidative metabolites in pharmacokinetic and bioequivalence studies.
• Analytical Method Development: Used as a critical standard for developing and validating HPLC, LC-MS, and other chromatographic methods for impurity profiling and assay determination.
• Metabolite Research: Essential for in vitro and in vivo studies investigating the metabolic pathways, stability, and pharmacokinetics of dabigatran etexilate.
• Quality Control & Impurity Testing: Employed as a specified impurity standard to ensure the purity and safety of active pharmaceutical ingredients (APIs) and finished drug products according to ICH guidelines.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings with agencies such as the FDA and EMA.

Basic Information

Product Name	Dabigatran Etexilate n-Oxide
CAS No.	1381757-44-3
Molecular Formula	C34H41N7O6
Molecular Weight	643.74 g/mol
Synonyms	BIBR 1048 n-Oxide; Dabigatran Etexilate Metabolite; Dabigatran Etexilate N-Oxide; 3-[[2-[[[4-[[[(Hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl](pyridin-2-yl)amino]propanoic acid ethyl ester N-oxide; Ethyl 3-((2-((4-(N'-(hexyloxy)carbonyl)carbamimidoyl)phenylamino)methyl)-1-methyl-1H-benzo[d]imidazole-5-carbonyl)(pyridin-2-yl)amino)propanoate N-oxide
EINECS	Contact for details

Quality Control

Our Dabigatran Etexilate n-Oxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical research and development. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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