Description

Obeticholic Acid Impurity 13 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 for primary biliary cholangitis. It serves as a key marker for ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient. This impurity standard is essential for analytical laboratories, pharmaceutical R&D departments, and quality assurance teams involved in method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Obeticholic Acid drug substance and drug products.
• Analytical Method Development and Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to monitor and control impurity levels according to ICH Q3A/B guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and during shelf-life studies.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient.

Basic Information

Product Name	Obeticholic Acid Impurity 13
CAS No.	1537866-49-1
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6-Ethylchenodeoxycholic Acid Impurity 13; INT-777 Impurity 13; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Related Compound; 6-ECDCA Impurity 13; OCA Impurity 13; (3α,5β,6α,7α)-6-Ethyl-3,7-dihydroxycholan-24-oic Acid Impurity; Obeticholic Acid Related Substance 13
EINECS	Contact for details

Quality Control

Every batch of Obeticholic Acid Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results for purity, impurities, and identification. We support compliance with ICH guidelines and cGMP standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term stability, storage at 2-8°C is recommended. 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 standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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