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:
1(10.0-10000)Milligram
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.
N-nitroso-N-desmethylnacotin
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