Description

Obeticholic Impurity 12 is a high-purity chemical reference standard used in the analytical profiling and quality control of Obeticholic Acid, a pharmaceutical agent. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Obeticholic Acid API and its formulations.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release: Essential for routine QA/QC testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Obeticholic Acid to minimize the formation of this impurity.

Basic Information

Product Name	Obeticholic Impurity 12
CAS No.	1885104-64-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Ethylchenodeoxycholic Acid Impurity 12; INT-747 Impurity 12; 6-ECDCA Impurity 12; OCA Impurity 12; Obeticholic Acid Related Compound 12; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Impurity 12; (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic Acid Impurity 12
EINECS	Contact for details

Quality Control

Our Obeticholic Impurity 12 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

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

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