Description

Ursodeoxycholic Acid Ep Impurity M CAS NO 110107-03-4 is a high-purity reference standard used in the pharmaceutical quality control process. This compound is critical for ensuring the safety and efficacy of ursodeoxycholic acid (UDCA) drug substances and finished products by serving as a known impurity marker. It is an essential material for analytical laboratories in the pharmaceutical industry, particularly those involved in method development, validation, and routine batch release testing to comply with stringent pharmacopeial monographs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, UPLC, and LC-MS analysis in quality control laboratories.
• Method Development and Validation: Critical for developing and validating analytical methods to detect and quantify impurities in Ursodeoxycholic Acid (UDCA) APIs according to EP, USP, and other pharmacopeial guidelines.
• Stability Studies: Used to monitor impurity profiles in UDCA drug substances and products during forced degradation and long-term stability testing.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Employed in R&D to study the degradation pathways and metabolism of ursodeoxycholic acid.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability component and for the identification and quantification of specified impurities in routine batch analysis.

Basic Information

Item	Details
Product Name	Ursodeoxycholic Acid Ep Impurity M
CAS No.	110107-03-4
Molecular Formula	C24H40O4
Molecular Weight	392.57 g/mol
Synonyms	3α,7β-Dihydroxy-5β-cholan-24-oic Acid Impurity M; Chenodeoxycholic Acid 7-Epimer Impurity; 7-Epichenodeoxycholic Acid Related Compound M; UDCA Impurity M; Ursodiol Impurity M; 7β-Epimer of Chenodeoxycholic Acid; 5β-Cholan-24-oic acid-3α,7β-diol
EINECS	Contact for details

Quality Control

Every batch of Ursodeoxycholic Acid Ep Impurity M is manufactured and controlled under a strict quality management system. The product is characterized and qualified using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Specific Rotation	Contact for details

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