Silodosin Impurity NEW

Product Information

Product Number: S013014

English Name: Silodosin Impurity 14

English Alias: (R)-5-(2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)-1H-indole-7-carboxamide

CAS Number: None

Molecular Formula: C₂₂H₂₄F₃N₃O₃

Molecular Weight: 435.44

Advantages

Analyzing the by-product formation mechanism of amination and etherification reactions during silodosin synthesis to optimize processes for controlling chiral impurity generation;

Serving as a chiral reference standard containing trifluoroethoxy and indole ring structures to provide a standard substance for detecting complex chiral impurities in drugs, improving the accuracy of enantiomer separation and detection;

Helping study the impact of trifluoro substituents and indole ring structures on drug stability and toxicological properties to provide a scientific basis for formulating impurity control strategies.

Applications

Drug Development: Used as a chiral impurity reference standard to identify and quantify Impurity 14 in silodosin preparations, evaluating the stereochemical purity of APIs and formulations;

Quality Control: Acting as a standard substance to validate the sensitivity of chiral HPLC or supercritical fluid chromatography (SFC) and other detection methods, ensuring chiral impurity content meets pharmacopoeia requirements during production;

Stability Studies: Simulating ether bond cleavage or amide hydrolysis pathways under drug storage conditions to assist in establishing storage conditions and shelf life.

Background Description

Research Status

Chiral Synthesis Processes: Developing highly stereoselective impurity synthesis methods to obtain single-configuration reference standards through chiral catalysts or resolution techniques;

Detection Technologies: Establishing high-resolution enantiomer separation and detection methods using chiral stationary phase HPLC or LC-MS combined techniques;

Toxicological Evaluation: Studying the impact of (R)-configuration on potential drug toxicity through in vitro cytotoxicity experiments;

Process Control: Analyzing the influence of parameters such as amination reaction temperature and solvent polarity on stereoselectivity to optimize conditions for reducing chiral impurity generation.