Description

Obeticholic Acid Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Obeticholic Acid, an active pharmaceutical ingredient used in treating primary biliary cholangitis. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies. Ensuring the integrity of this impurity standard is fundamental to guaranteeing the safety and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Obeticholic Acid Impurity 20 in drug substances and products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Obeticholic Acid to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Utilized to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic chemistry research, degradation pathway studies, and the development of purification processes for Obeticholic Acid.

Basic Information

Product Name	Obeticholic Acid Impurity 20
CAS No.	1620095-11-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Ethylchenodeoxycholic Acid Impurity 20; INT-777 Impurity 20; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Related Compound; OCA Impurity 20; 6-ECDCA Impurity 20; Obeticholic Acid Related Substance 20; 6α-Ethylchenodeoxycholic Acid Impurity
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 20 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines.

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 strictly light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and protected from all light exposure during storage and handling to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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