Description

Obeticholic Acid 3-o-β-D-Glucuronide is a key metabolite and pharmaceutical reference standard of obeticholic acid, a potent farnesoid X receptor (FXR) agonist. This high-purity compound is essential for advanced research, method development, and quality control in drug metabolism and pharmacokinetics (DMPK) studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) for the development and analysis of next-generation therapies for liver diseases.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified standard for the quantitative and qualitative analysis of obeticholic acid and its metabolites in biological matrices and finished drug products.
• Drug Metabolism & Pharmacokinetics (DMPK): Used in in vitro and in vivo studies to understand the metabolic pathway, bioavailability, and excretion profile of obeticholic acid.
• Bioanalytical Method Development: Essential for developing and validating sensitive HPLC, LC-MS, and LC-MS/MS methods for therapeutic drug monitoring and clinical trial sample analysis.
• Impurity Profiling: Employed as a known impurity or degradation product standard to ensure the purity and stability of obeticholic acid API according to ICH guidelines.
• Preclinical & Clinical Research: Supports investigative studies on the efficacy, safety, and mechanism of action of FXR-targeted therapies for conditions like primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH).

Basic Information

Item	Details
Product Name	Obeticholic Acid 3-o-β-D-Glucuronide
CAS No.	2270232-93-2
Molecular Formula	C32H48O10
Molecular Weight	592.72 g/mol
Synonyms	6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid 3-O-β-D-Glucuronide; INT-777 Glucuronide; OCA 3-O-Glucuronide; 6-ECDCA 3-O-Glucuronide; 6α-Ethylchenodeoxycholic Acid 3-O-β-D-Glucuronide; Obeticholic Acid 3-O-Glucuronide Metabolite; 6-ECDCA 3-Glucuronide
EINECS	Contact for details

Quality Control

Our Obeticholic Acid 3-o-β-D-Glucuronide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry environment. Due to its hygroscopic nature, the product should be allowed to equilibrate to room temperature in a desiccator before opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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