Description

Obeticholic Acid is a potent and selective farnesoid X receptor (FXR) agonist, representing a significant advancement in targeted therapeutic agents. This high-purity compound is critical for pharmaceutical research and development, offering a key building block for novel treatments. It is primarily utilized by pharmaceutical companies, research institutions, and CROs/CMOs engaged in developing therapies for chronic liver diseases and metabolic disorders.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of prescription medications targeting primary biliary cholangitis (PBC).
• Pharmaceutical Reference Standard for quality control, method development, and validation in analytical laboratories.
• Biochemical Research for studying FXR receptor pathways, bile acid metabolism, and liver function.
• Preclinical and Clinical Development as a key intermediate in the synthesis of new chemical entities for metabolic and liver diseases.
• Process Chemistry for scale-up and optimization of synthetic routes in a GMP environment.

Basic Information

Product Name	Obeticholic Acid
CAS No.	459789-99-2
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6α-Ethylchenodeoxycholic Acid; 6-ECDCA; INT-747; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid; Cholbam Impurity; OCA
EINECS	Contact for details

Quality Control

Our Obeticholic Acid is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH guidelines and relevant pharmacopeial standards.

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 spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%

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