Dotinurad Impurity 72 NEW

Dotinurad Impurity 72;C15H13NO4S 

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WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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• Product Information

• Product Code：D081072

• English Name：Dotinurad Impurity 72

• English Alias：benzo[d]thiazol-3(2H)-yl(4-methoxyphenyl)methanone

• CAS No.：Not provided

• Molecular Formula：C₁₅H₁₃NO₂S

• Molecular Weight：271.33

• Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Dotinurad impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 72 in Dotinurad API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Dotinurad synthesis, reducing generation by >30% by adjusting condensation temperature (e.g., 60-70℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

• Background Description

• Dotinurad, a selective urate transporter 1 (URAT1) inhibitor, is used for treating hyperuricemia and gout by promoting uric acid excretion to reduce blood uric acid levels. Impurity 72, a process-related impurity in its synthesis, may originate from condensation side reactions between benzothiazole rings and methoxybenzoyl groups. Its thiazole ring, methoxy group, and ketone group may affect drug lipophilicity, metabolic stability, and efficacy. Strict impurity control for anti-gout drugs is critical to drug quality, making research on this impurity essential.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nucleophilic substitution of 4-methoxybenzoyl chloride with benzothiazol-3(2H)-one under alkaline catalyst (e.g., triethylamine); optimizing catalyst dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 185.7 μM against HK-2 cells (Dotinurad IC₅₀=10.5 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity conditions

NOTE！

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

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The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!