Product Information

Product Code: C125005

English Name: Chenodeoxycholic Acid Impurity 5

English Alias: (R)-methyl 4-((5R,7R,8R,9S,10S,13R,14S,17R)-7-acetoxy-10,13-dimethyl-3-oxohexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoate

CAS No.：60354-41-8

Molecular Formula: C??H??O?

Molecular Weight: 446.62

Advantages

High-Purity Reference Standard: As an impurity reference standard for Chenodeoxycholic Acid, it features a defined chemical structure and stable physicochemical properties, enabling qualitative and quantitative analysis of impurities in pharmaceutical quality control.

Structural Specificity: Its specific stereoconfiguration and functional groups (such as acetoxy and keto groups) accurately simulate impurities that may arise during drug synthesis or storage, ensuring the accuracy of detection methods.

Applications

Pharmaceutical R&D and Quality Control: Used for detecting impurity limits in Chenodeoxycholic Acid and its formulations, assisting in evaluating drug purity and safety to meet the impurity control requirements of pharmacopoeias and international guidelines (e.g., ICH).

Analytical Method Validation: Serves as a reference substance for developing and validating the specificity, sensitivity, and precision of analytical methods like HPLC and MS.

Background Description

Research Status

Detection Technology: Quantitative analysis of trace impurities using highly sensitive methods like UPLC-MS/MS.

Formation Mechanism: Research indicates it may originate from oxidation, acetylation, or ester bond hydrolysis of Chenodeoxycholic Acid, requiring targeted control in the production process.

Regulatory Requirements: Pharmacopoeias and guidelines worldwide specify limits for such impurities, promoting the widespread use of impurity reference standards in pharmaceutical R&D.