Description

Tauro Obeticholic Acid is a potent, semi-synthetic bile acid derivative and a key pharmaceutical intermediate. This compound is of significant commercial and therapeutic interest due to its role as the active metabolite of Obeticholic Acid, a farnesoid X receptor (FXR) agonist. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of advanced therapies for chronic liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Critical synthesis precursor for the production of Obeticholic Acid and related therapeutic agents.
• Metabolite Reference Standard: Used in bioanalytical laboratories for pharmacokinetic and pharmacodynamic studies to quantify drug metabolism.
• Hepatology Research: Serves as a vital tool in preclinical and clinical research targeting FXR pathways for liver disease treatment.
• Process Development & Scale-up: Employed in process chemistry for optimizing manufacturing routes and ensuring consistent API quality.
• Formulation Studies: Utilized in developing stable and bioavailable dosage forms for new drug candidates.
• Quality Control & Regulatory Submissions: Acts as a certified reference material for analytical method validation and regulatory compliance dossiers.

Basic Information

Product Name	Tauro Obeticholic Acid
CAS No.	863239-61-6
Molecular Formula	C₂₆H₄₅NO₆S
Molecular Weight	499.71 g/mol
Synonyms	6α-Ethylchenodeoxycholic Acid 3α-Sulfate Taurine Conjugate; INT-777; 6-ECDCA Taurine Conjugate; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid N-(2-Sulfoethyl)amide; Obeticholic Acid Taurine Conjugate; Tauroursodeoxycholic Acid Ethyl Derivative; Taurine-conjugated 6α-Ethylchenodeoxycholic Acid
EINECS	Contact for details

Quality Control

Our Tauro Obeticholic Acid is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and stringent control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with cGMP and ICH guidelines for pharmaceutical intermediates.

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 (e.g., nitrogen atmosphere) for long-term storage to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.