N-(4-Hydroxyphenethyl)-N-methylnitrous Amide;84605-04-9
Product Code：N031287
English Name：N-(4-Hydroxyphenethyl)-N-methylnitrous Amide
English Alias：N-(4-hydroxyphenethyl)-N-methylnitrous amide
CAS No.：84605-04-9
Molecular Formula：C₉H₁₂N₂O₂
Molecular Weight：180.20
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR, and HRMS, suitable for qualitative/quantitative analysis of nitrosamine impurities.
Controllable Stability：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol solution within 1 month.
Drug Safety Testing：Used for LC-MS/MS detection of N-nitroso impurities in related drugs, complying with ICH M7 guidelines for genotoxic impurities.
Process Optimization：Monitors nitrosation side reactions during drug synthesis to reduce impurity formation via condition adjustment.
This compound belongs to nitrosamines, potentially formed by reactions between amines and nitrosating agents during drug synthesis or storage. Nitrosamines pose genotoxic risks, and regulatory agencies (FDA, EMA) enforce strict limits, making research on such impurities crucial for drug quality control.
Current research focuses on developing detection methods (e.g., UPLC-MS/MS) and analyzing formation mechanisms of nitrosamine impurities. Studies show that process optimization or inhibitor addition can reduce their content, with toxicology indicating potential mutagenicity requiring limits below 0.1 ppm.
China
