Description

Obeticholic Acid Impurity 31 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of Obeticholic Acid, an important pharmaceutical agent. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and impurity profiling. Ensuring the integrity of this impurity standard is essential for accurate method validation and product safety assessments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Obeticholic Acid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing, optimizing, and validating chromatographic methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Obeticholic Acid.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and synthetic chemistry research related to Obeticholic Acid and its analogs.

Basic Information

Product Name	Obeticholic Acid Impurity 31
CAS No.	1312468-30-6
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Impurity 31; INT-747 Impurity 31; 6-ECDCA Impurity 31; OCA Impurity 31; 6α-Ethylchenodeoxycholic Acid Impurity 31; (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic Acid Related Compound 31
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 31 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing comprehensive test results for identity, purity, and impurities. We support compliance with ICH guidelines and relevant pharmacopeial standards.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.