Description

Obeticholic Acid Impurity A is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of Obeticholic Acid, an active pharmaceutical ingredient used in treating primary biliary cholangitis. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in method development, validation, and regulatory compliance. Ensuring the integrity of your impurity profiling directly impacts drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in quality control laboratories.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods for the quantification of impurities in Obeticholic Acid drug substance and finished products.
• Stability Studies: Employed as a marker to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of pharmaceutical formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and demonstrate control strategies.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits for Obeticholic Acid.

Basic Information

Product Name	Obeticholic Acid Impurity A
CAS No.	865244-30-0
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6α-Ethylchenodeoxycholic Acid Impurity A; 6-ECDCA Impurity A; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Impurity A; INT-777 Impurity A; OCA Impurity A; 6-EDCA Impurity A; 6α-Ethyl-5β-cholan-3α,7α-diol-24-oic Acid Impurity A
EINECS	Contact for details

Quality Control

Every batch of Obeticholic Acid Impurity A is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standards, ensuring high purity, accurate identification, and precise quantification. Certificates of Analysis (COA) are provided with each shipment, detailing results from tests including identification, assay, and related substance analysis by validated methods such as HPLC and NMR.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is light-sensitive (store away from light) and should be handled under inert conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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