Description

Obeticholic Acid Impurity 13 is a high-purity reference standard specifically identified as a process-related impurity of Obeticholic Acid. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control of the active pharmaceutical ingredient. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Obeticholic Acid and related drug substances.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Obeticholic Acid Impurity 13 in drug substance and drug product batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation pathways in Obeticholic Acid formulations.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., FDA, EMA) to establish impurity specifications and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Obeticholic Acid by identifying and controlling process-related impurities.

Basic Information

Product Name	Obeticholic Acid Impurity 13
CAS No.	2061908-14-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	6-Ethylchenodeoxycholic Acid Impurity 13; INT-747 Impurity 13; 3α,7α-Dihydroxy-6α-ethyl-5β-cholan-24-oic Acid Impurity 13; OCA Impurity 13; 6α-Ethylchenodeoxycholic Acid Related Compound 13; 6-ECDCA Impurity 13; Obeticholic Acid Related Substance 13
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against stringent in-house specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 2.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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