N-Nitroso Dabigatran Etexilate
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：N031070
English Name：N-Nitroso Dabigatran Etexilate
English Alias：ethyl 3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate
CAS No.：2892260-29-4
Molecular Formula：C₃₄H₄₀N₈O₆
Molecular Weight：656.73
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for nitroso impurity analysis of Dabigatran Etexilate.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of nitroso impurity in Dabigatran Etexilate API and formulations, meeting ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during synthesis, reducing generation by >40% by adjusting nitrosation temperature (e.g., 0-5℃) and pH.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Dabigatran Etexilate, a direct thrombin inhibitor, is used to prevent thromboembolic events in non-valvular atrial fibrillation patients. N-Nitroso Dabigatran Etexilate, as a nitrosated impurity, may originate from side reactions between amino groups and nitrites during synthesis. Its nitroso, carbamimidoyl, and benzimidazole groups may affect drug stability, anticoagulant activity, and safety. Due to the potential genotoxicity of nitroso compounds, global regulatory agencies impose strict control, making research on this impurity crucial for ensuring drug quality.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution separates impurities within 12 min, with LOD of 0.005 ng/mL for trace analysis.
Formation Mechanism：Formed by nitrosation of Dabigatran Etexilate intermediates with nitrites under acidic conditions (e.g., pH < 4); optimizing reaction pH and nitrite dosage inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 172.5 μM against HUVEC cells (Dabigatran Etexilate 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 different humidity, light, and temperature 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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