Description

Obeticholic Acid Impurity 2 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 medication used to treat primary biliary cholangitis. It serves as a key marker for identifying and quantifying process-related impurities, ensuring the final drug product meets stringent regulatory purity standards. Researchers and quality assurance professionals in pharmaceutical development and contract manufacturing organizations rely on this impurity standard for method validation and batch release testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Obeticholic Acid Impurity 2 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Release Testing: Essential for in-process control and final release testing of Obeticholic Acid to ensure compliance with ICH Q3A/B guidelines and regulatory filings.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides necessary data for impurity identification reports required by agencies such as the FDA and EMA in New Drug Applications (NDAs).
• Contract Research and Manufacturing (CRO/CMO): Supports outsourcing partners in providing compliant analytical services and manufacturing for Obeticholic Acid.

Basic Information

Item	Details
Product Name	Obeticholic Acid Impurity 2
CAS No.	915038-27-6
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6-Ethylchenodeoxycholic Acid Impurity 2; INT-767 Impurity 2; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Related Compound; OCALIVA Impurity 2; 6-ECDCA Impurity 2; (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Obeticholic Acid Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with ICH guidelines and can supply materials suitable for regulatory submission purposes.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.