Description

Obeticholic Acid Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Obeticholic Acid, a pharmaceutical active ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control processes.

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: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency and purity.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability studies of Obeticholic Acid.
• Research & Development: Supports synthetic chemistry research, including route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Obeticholic Acid Impurity 4
CAS No.	61800-60-0
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6-Ethylchenodeoxycholic Acid; 6α-Ethylchenodeoxycholic Acid; 6-ECDCA; INT-767 Impurity; 3α,7α-Dihydroxy-6α-ethyl-5β-cholan-24-oic Acid; OCA Impurity 4; 6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 must be kept under inert atmosphere or desiccated conditions after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.