Product Number: D081041
English Name: Dotinurad Impurity 41
English Alias: (1,1-dioxidobenzo[d]thiazol-3(2H)-yl)(4-hydroxyphenyl)methanone
CAS Number: None
Molecular Formula: C₁₄H₁₁NO₄S
Molecular Weight: 289.31
As a sulfone impurity of dotinurad, the research advantages of this compound lie in:
Analyzing the by-product formation mechanism of oxidation reactions during dotinurad synthesis to optimize processes for controlling sulfone impurity generation;
Serving as a reference standard containing hydroxyl and sulfone groups to provide a standard substance for detecting polar impurities in drugs, assisting in evaluating drug purity;
Helping study the impact of sulfone and hydroxyl structures on drug stability and toxicological properties to provide a basis for formulating impurity control strategies.
Drug Development: Used as an impurity reference standard to identify and quantify Impurity 41 in dotinurad 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 LC-MS), ensuring sulfone impurity content meets pharmacopoeia requirements during production;
Stability Studies: Simulating oxidation pathways under drug storage conditions to assist in establishing storage conditions and shelf life.
Dotinurad, a uric acid transporter inhibitor for treating gout, involves sulfur oxidation reactions during synthesis, prone to generating sulfone or sulfoxide impurities. Dotinurad Impurity 41, as an impurity containing benzothiazole sulfone and hydroxyphenyl structures, may be formed during the oxidation step or subsequent purification. Its content directly affects drug quality. Since sulfone impurities may affect drug activity or cause safety issues, research on this impurity has become an important part of dotinurad quality control.
Current research focuses on:
Synthesis Process: Developing high-purity synthesis methods for sulfone impurities to solve the purification challenge of polar compounds and obtain reference standards;
Detection Technologies: Establishing highly sensitive detection methods for this polar impurity using reverse-phase HPLC combined with UV or mass spectrometry detectors;
Toxicological Evaluation: Studying the potential biological effects of sulfone and hydroxyl structures through in vitro cytotoxicity experiments;
Process Control: Analyzing the influence of oxidation reaction conditions (such as oxidant type, temperature) on impurity formation to optimize parameters for reducing its content
China
