Description

Ursulcholic is a high-purity bile acid derivative, also known as Ursodeoxycholic Acid EP Impurity C. This compound is of significant importance as a key reference standard and intermediate in pharmaceutical research and development, particularly for quality control and analytical purposes. It is primarily needed by manufacturers and R&D laboratories in the pharmaceutical and biotechnology sectors working on hepatoprotective and metabolic drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ursodeoxycholic Acid (UDCA) active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Research: Serves as a critical component in method development and validation for HPLC, UPLC, and other chromatographic techniques within quality control laboratories.
• Process Chemistry Intermediate: Employed as a synthetic building block or intermediate in the research-scale production of specialized bile acid analogs and derivatives.
• Metabolic Pathway Studies: Utilized in biochemical and pharmacological research to study bile acid metabolism, transport, and related biological mechanisms.
• Impurity Profiling: Essential for creating impurity profiles and setting specifications for UDCA according to pharmacopeial standards (EP, USP).

Basic Information

Product Name	Ursulcholic
CAS No.	88426-32-8
Molecular Formula	C24H40O4
Molecular Weight	392.57 g/mol
Synonyms	Ursodeoxycholic Acid EP Impurity C; 3α,7β-Dihydroxy-5β-cholan-24-oic Acid; Ursodeoxycholic Acid Impurity C; 7β-Epimer of Chenodeoxycholic Acid; UR-982; (3α,5β,7β)-3,7-Dihydroxycholan-24-oic Acid; 3α,7β-Dihydroxy-5β-cholanoic Acid
EINECS	Contact for details

Quality Control

Our Ursulcholic is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR) and purity assessment by HPLC, to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary 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). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%

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