Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Lab/Research institutions
Tel: +86-173-20513646
Mobile: 17320513646
Tel: +86-173-20513646
Fax:
Province/state: Hu Bei
City: Wuhan
Street: Company address: Room 005, 15th Floor, Building D2, Phase III, Software New Town, No. 8 Huacheng Avenue, East Lake High-tech Development Zone, Wuhan, Hubei Province, China
MaxCard:
CAS NO.13276-52-3
1(10.0-10000)Milligram
Advantages
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Regadenoson impurity analysis and quality control.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Regadenoson Impurity;13276-52-3
Product Information
Product Code:R013031
English Name:Regadenoson Impurity 31
English Alias:(2S,3R,4S,5R)-2-(2,6-dichloro-9H-purin-9-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol
CAS No.:13276-52-3
Molecular Formula:C??H??Cl?N?O?
Molecular Weight:321.12
Advantages
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Regadenoson impurity analysis and quality control.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Applications
Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 31 in Regadenoson API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research:Monitors impurity formation during Regadenoson synthesis, reducing generation by >30% by adjusting chlorination 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
Regadenoson, a selective A2A adenosine receptor agonist, is used for myocardial perfusion imaging to assess coronary blood flow. Impurity 31, a process-related impurity in its synthesis, may originate from chlorinated condensation side reactions between purine rings and glycosyl compounds. Its chlorine atoms, purine ring, and polyol groups may affect drug hydrophilicity, stability, and receptor binding efficiency. Strict impurity control for cardiovascular drugs is critical to patient safety, making research on this impurity essential 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 7 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism:Formed by condensation of 2,6-dichloropurine with glycosyl derivatives under acidic catalyst (e.g., p-toluenesulfonic acid); optimizing catalyst dosage and reaction pH (e.g., adjusting to neutral) inhibits side reactions.
Safety Evaluation:In vitro cytotoxicity shows IC?? of 185.4 μM against H9c2 cardiac cells (Regadenoson IC??=7.6 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 and its potential impact on the main drug.