Description

Cholic Acid Impurity (5-β-Cholane-3-α-7-β-24-Triol) is a high-purity reference standard and a key chemical impurity of cholic acid, a primary bile acid. This compound is critical for analytical method development and validation, ensuring the quality and safety of pharmaceutical products derived from or related to bile acids. It is primarily utilized by pharmaceutical R&D laboratories, quality control departments, and contract research organizations (CROs) specializing in steroidal and metabolic drug development.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in cholic acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Used to develop, validate, and calibrate chromatographic methods (e.g., HPLC, UPLC) for purity analysis in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance: Essential for routine batch testing in QC labs to monitor impurity profiles and ensure API specifications are met for GMP manufacturing.
• Metabolic Pathway Research: Acts as a specific intermediate or marker in biochemical and pharmacological studies of bile acid synthesis and metabolism.
• Regulatory Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.

Basic Information

Product Name	Cholic Acid Impurity (5-β-Cholane-3-α-7-β-24-Triol)
CAS No.	130593-75-8
Molecular Formula	C24H42O4
Molecular Weight	394.59 g/mol
Synonyms	5β-Cholane-3α,7β,24-triol; 3α,7β,24-Trihydroxy-5β-cholane; 24-Hydroxycholic Acid Impurity; Cholic Acid Related Compound; 7β-Hydroxy-3α,24-dihydroxy-5β-cholane; 5β-Cholan-24-oic acid, 3α,7β-dihydroxy-; (3α,5β,7β)-3,7,24-Trihydroxycholane
EINECS	Contact for details

Quality Control

Our Cholic Acid Impurity is manufactured under strict quality systems to ensure batch-to-batch consistency and reliability for critical analytical applications. Each lot undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR), purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the analytical results against predefined specifications.

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); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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