Keywords

• O-(3,5-dichloro-4-methoxybenzoyl)-N-phenylhydroxylamine
• Dotinurad Impurity
• 428458-98-4

Quick Details

• ProName: Dotinurad Impurity;428458-98-4
• CasNo: 428458-98-4
• Molecular Formula: C14H11Cl2NO2
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

• 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.

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Details

Dotinurad Impurity;428458-98-4

Product Information

• Product Code：D081070

• English Name：Dotinurad Impurity 70

• English Alias：3,5-dichloro-4-methoxy-N-phenylbenzamide

• CAS No.：428458-98-4

• Molecular Formula：C??H??Cl?NO?

• Molecular Weight：296.15

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 70 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 amidation temperature (e.g., 50-60℃) 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 uric acid transporter 1 (URAT1) inhibitor, is used for treating hyperuricemia and gout. Impurity 70, as a process-related impurity in Dotinurad synthesis, may originate from side reactions between chlorobenzoyl chloride and aniline. Its chlorine atoms, methoxy, and benzamide groups may affect drug solubility, stability, and target binding. With stricter requirements for gout drug impurities, studying this impurity is crucial for ensuring drug quality.

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 condensation of 3,5-dichloro-4-methoxybenzoyl chloride with aniline under alkaline conditions (e.g., triethylamine/dichloromethane system); optimizing base dosage and reaction temperature inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 186.5 μM against HEK293 cells (Dotinurad IC??=8.7 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.