Description

Obeticholic Acid-[D4] is a high-purity, deuterium-labeled stable isotope analog of the primary bile acid FXR agonist, obeticholic acid. This compound is an essential internal standard for the precise quantification of obeticholic acid and its metabolites in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Bioanalytical Internal Standard: Serves as a critical reference standard in LC-MS/MS and GC-MS assays for the accurate measurement of obeticholic acid in plasma, serum, and tissue samples.
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies: Enables reliable tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Identification and Profiling: Aids in the structural elucidation and quantification of drug metabolites, supporting metabolic pathway analysis.
• Method Development and Validation: Used as a certified reference material to establish specificity, accuracy, and precision in new analytical methods for regulatory submissions.
• Drug Impurity Testing: Can be employed as a marker in stability studies and impurity profiling of obeticholic acid drug substances and products.
• Isotope Dilution Mass Spectrometry (IDMS): Provides the highest accuracy in quantitative analysis due to its nearly identical chemical properties to the analyte.

Basic Information

Product Name	Obeticholic Acid-[D4]
CAS No.	2025364-15-0
Molecular Formula	C26H40D4O4
Molecular Weight	424.65 g/mol
Synonyms	6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid-d4; 6-ECDCA-d4; INT-747-d4; OCA-d4; 6α-Ethylchenodeoxycholic Acid-d4; Deuterated Obeticholic Acid; [D4]-Obeticholic Acid
EINECS	Contact for details

Quality Control

Our Obeticholic Acid-[D4] is manufactured under strict quality systems to ensure the highest isotopic purity and chemical integrity required for sensitive mass spectrometry applications. Each batch is characterized by advanced spectroscopic methods (NMR, HRMS) and undergoes rigorous HPLC analysis to confirm chemical and isotopic purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific data including assay, isotopic enrichment, and chromatographic purity, supporting compliance with GLP and ISO 17025 standards.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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