Description

Obeticholic Acid Impurity 5 is a high-purity reference standard and a key process-related impurity in the synthesis of Obeticholic Acid. This compound is critical for pharmaceutical research and development, enabling precise analytical method development and quality control for the active pharmaceutical ingredient. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Obeticholic Acid drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release Testing: Serves as a system suitability component and an impurity marker in the routine QC testing of Obeticholic Acid to ensure it meets specified purity limits.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and characterization data as per ICH Q3A(R2) and Q3B(R2) requirements.
• Process Chemistry Research: Used in synthetic route optimization and impurity fate and tolerance studies to improve the manufacturing process of Obeticholic Acid.
• Stability Studies: Employed to monitor impurity levels in forced degradation and long-term stability studies of Obeticholic Acid formulations.

Basic Information

Product Name	Obeticholic Acid Impurity 5
CAS No.	130081-08-2
Molecular Formula	C26H44O4
Molecular Weight	420.63 g/mol
Synonyms	6α-Ethyl-3α,7α-dihydroxy-5β-cholan-24-oic Acid Impurity 5; INT-777 Impurity 5; 6-ECDCA Impurity 5; 6α-Ethylchenodeoxycholic Acid Impurity 5; OCA Impurity 5; 6α-Ethyl-3α,7α-dihydroxy-5β-cholanic Acid Related Compound 5
EINECS	Contact for details

Quality Control

Our Obeticholic Acid Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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