Description

Dabigatran Acyl-β-D-Glucuronide is a major pharmacologically active metabolite of the direct thrombin inhibitor, dabigatran etexilate. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug development and analytical chemistry.

Application

• Reference Standard for Bioanalysis: Serves as a certified reference material (CRM) for the quantification of dabigatran and its metabolites in biological matrices (plasma, serum, urine) using LC-MS/MS and HPLC methods.
• Pharmacokinetic & Metabolism Studies: Essential for investigating the metabolic pathways, clearance mechanisms, and exposure-response relationships of dabigatran etexilate in preclinical and clinical research.
• Impurity Profiling and Characterization: Used to identify, qualify, and control this specific glucuronide conjugate as a potential impurity or degradation product in dabigatran etexilate active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Submission Support: Provides vital data for regulatory filings (e.g., FDA, EMA) to demonstrate understanding of the drug's metabolic fate and to validate analytical procedures.
• In-vitro Enzyme Assay Development: Employed in studies to assess the activity of UDP-glucuronosyltransferase (UGT) enzymes and potential drug-drug interactions.

Basic Information

Product Name	Dabigatran Acyl-β-D-Glucuronide
CAS No.	1015167-40-4
Molecular Formula	C34H41N7O14
Molecular Weight	771.73 g/mol
Synonyms	Dabigatran Acyl Glucuronide; Dabigatran O-Acyl-β-D-Glucuronide; BIBR 1048 Acyl Glucuronide; (3-{(2-{[(4-{[(Hexyloxy)carbonyl]amino}phenyl)carbonyl]amino}-5-{[2-(pyridin-2-ylamino)ethyl]carbamoyl}phenyl)aminomethyl}phenyl) β-D-Glucopyranosiduronic Acid; Dabigatran Ester Glucuronide; Dabigatran Metabolite; 1-O-{3-[({2-[(4-{[(Hexyloxy)carbonyl]amino}benzoyl)amino]-5-[(2-{[(pyridin-2-yl)amino]ethyl})carbamoyl]phenyl})carbamimidoyl]phenyl} β-D-Glucopyranuronic Acid
EINECS	Contact for details

Quality Control

Our Dabigatran Acyl-β-D-Glucuronide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC (purity), LC-MS/MS (identity confirmation), and NMR spectroscopy, to ensure compliance with research-grade standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH guidelines

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