Regadenoson Impurity NEW

Regadenoson Impurity;2004-07-1

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

Product Information

• Product Code：R013030

• English Name：Regadenoson Impurity 30

• English Alias：(2R,3R,4S,5R)-2-(2-amino-6-chloro-9H-purin-9-yl)-5-(hydroxymethyl)tetrahydrofuran-3,4-diol

• CAS No.：2004-07-1

• Molecular Formula：C₁₀H₁₂ClN₅O₄

• Molecular Weight：301.69

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 30 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 >35% by adjusting amination temperature (e.g., 60-70℃) and pH.

• 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 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nucleophilic substitution of 2,6-dichloropurine with glycosyl compounds in ammonia solution; optimizing reaction temperature and ammonia concentration inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 178.5 μM against H9c2 cardiac cells (Regadenoson IC₅₀=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 high temperature (40℃) and high humidity (75%RH) 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

NEW IN STOCK!

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