Regadenoson Impurity NEW

Regadenoson Impurity;13276-52-3

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

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：C₁₀H₁₀Cl₂N₄O₄

• 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

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 IC₅₀ of 185.4 μM against H9c2 cardiac cells (Regadenoson IC₅₀=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.

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!