N-nitroso-N-desmethylnacotin

Details:

N-nitroso-N-desmethylnacotin

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• Product Information

• Product Code：N031289

• English Name：N-nitroso-N-desmethylnacotin

• English Alias：(S)-6,7-dimethoxy-3-((R)-4-methoxy-6-nitroso-5,6,7,8-tetrahydro-[1,3]dioxolo[4,5-g]isoquinolin-5-yl)isobenzofuran-1(3H)-one

• CAS No.：Not provided (to be supplemented)

• Molecular Formula：C??H??N?O?

• Molecular Weight：428.39

• Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for nitroso impurity analysis of Naltrexone.

• 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 nitroso impurity in Naltrexone 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).

• Background Description

• Naltrexone, an opioid receptor antagonist, is used for treating opioid dependence and alcohol dependence. N-nitroso-N-desmethylnacotin, as a nitrosated impurity, may originate from side reactions between amino groups and nitrites during synthesis. Its nitroso, isoquinoline, and ester groups may affect drug stability, receptor binding, and safety. Due to the potential genotoxicity of nitroso compounds, global regulatory agencies impose