Dotinurad Impurity68 NEW

Dotinurad Impurity 68

Product Information

• Product Code: D081068

• English Name: Dotinurad Impurity 68

• English Alias: 3-nitroso-2,3-dihydrobenzo[d]thiazole 1,1-dioxide

• CAS No.：39884-80-5

• Molecular Formula: C₇H₆N₂O₃S

• Molecular Weight: 198.20

Advantages

• High-purity reference standard suitable for qualitative and quantitative analysis of drug impurities, ensuring the accuracy and reliability of test results.

• Well-defined structure with traceable synthesis routes, meeting the strict requirements of drug R&D, quality control, and regulatory submissions.

Applications

• Primarily used for impurity analysis of the gout treatment drug Dotinurad, serving as a reference standard in detection methods such as HPLC and LC-MS to monitor impurity residues in the drug production process.

• Supports pharmaceutical quality research to help pharmaceutical companies comply with the impurity limit requirements of domestic and international regulatory agencies (e.g., FDA, EMA, NMPA).

Background Description

Research Status

1. Development of analytical methods: Establishing specific and sensitive detection methods (such as UPLC-MS/MS) to achieve precise determination of trace impurities.

2. Toxicological evaluation: Assessing the potential toxicity of the impurity through in vitro and in vivo tests to provide data support for setting safety thresholds.

3. Process optimization: Studying the formation mechanism of impurities and reducing their generation through improved synthesis routes or purification processes to ensure the controllability of the drug production process.

4. Compliance with international standards: Referencing international guidelines such as ICH Q3A/B/C to classify impurities and set limits, promoting the international registration process of drugs.