Probucol Impurity16 NEW

Product Information

• Product Number: P063016

• English Name: Probucol Impurity 16

• English Alias: ethyl 3,5-di-tert-butyl-4-hydroxybenzenesulfonate

• CAS Number: None

• Molecular Formula: C₁₆H₂₆O₄S

• Molecular Weight: 314.44

Advantages

• Analyzing the by-product formation mechanism of sulfonation or esterification reactions during probucol synthesis to optimize processes for controlling sulfonate ester impurity generation;

• Serving as a reference standard containing ester and sulfonic acid groups to provide a standard substance for detecting mixed lipophilic and polar impurities in drugs, improving detection accuracy;

• Helping study the impact of ester and sulfonic acid groups on drug stability and in vivo metabolism to provide a scientific basis for formulating impurity control strategies.

Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 16 in probucol preparations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity of detection methods (e.g., HPLC or GC-MS), ensuring sulfonate ester impurity content meets pharmacopoeia requirements during production;

• Stability Studies: Simulating ester hydrolysis or sulfonation pathways under drug storage conditions to assist in establishing storage conditions and shelf life.

Background Description

Research Status

• Synthesis Process: Developing high-purity synthesis methods for sulfonate ester impurities to solve the separation challenges in ester compound purification;

• Detection Technologies: Establishing highly sensitive detection methods for this impurity using reverse-phase HPLC combined with evaporative light scattering detector (ELSD) or mass spectrometry (MS);

• Toxicological Evaluation: Studying the potential biological effects of ester and sulfonic acid groups through in vitro cytotoxicity experiments;

• Process Control: Analyzing the influence of parameters such as sulfonation reaction temperature and esterification reagent dosage on impurity formation to optimize processes for reducing its content.