Description

Obeticholic Acid Impurity 32 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of Obeticholic Acid, a drug used to treat primary biliary cholangitis. It is essential for laboratories and manufacturers requiring precise impurity profiling and method validation to ensure drug safety and regulatory compliance. This impurity standard supports activities in research, process development, and quality assurance within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Obeticholic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Utilized as a marker to track impurity formation and degradation pathways in stability testing of Obeticholic Acid under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways by identifying and quantifying process-related impurities.

Basic Information

Product Name	Obeticholic Acid Impurity 32
CAS No.	1831863-02-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	OCA Impurity 32; 6α-Ethylchenodeoxycholic Acid Impurity 32; INT-747 Impurity 32; 6-ECDCA Impurity 32; (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic Acid Related Compound 32; Obeticholic Acid Related Substance 32
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 32 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm its suitability as a reference standard. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profile, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%

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