Product Code：M091001
English Name：N-Nitroso Maprotiline
English Alias：N-(3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)propyl)-N-methylnitrous amide
CAS No.：204268-61-1
Molecular Formula：C₂₀H₂₂N₂O
Molecular Weight：306.40
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR, and HRMS, suitable for precise analysis of nitrosamine impurities in Maprotiline.
Stability Assurance：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <1% in acetonitrile solution within 3 months.
Quality Control Testing：Used for LC-MS/MS detection of N-nitroso impurities in Maprotiline API and formulations, controlling impurity content to meet ICH M7 standards (≤0.1 ppm).
Process Optimization Research：Monitors N-Nitroso Maprotiline generated from nitrosation side reactions during Maprotiline synthesis, reducing formation by adjusting reaction temperature (e.g., 0-5℃) and pH (weak alkaline conditions).
Method Validation：Serves as a standard for developing nitrosamine detection methods, verifying UPLC resolution (≥2.0) and LOD (0.005 ng/mL).
Maprotiline, a tetracyclic antidepressant, may contain N-nitroso compounds (such as N-Nitroso Maprotiline) with potential genotoxicity and carcinogenicity, formed by reactions between secondary amines and nitrosating agents during synthesis. With stricter control requirements from international regulatory agencies (FDA, EMA), studying such impurities has become crucial for ensuring Maprotiline safety.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.5 minutes, with LOD of 0.003 ng/mL for trace analysis.
Formation Mechanism：Originates from nitrosation of the amine group in Maprotiline under acidic conditions (pH <3). Adding nitrosamine inhibitors (e.g., ascorbic acid) or optimizing purification (e.g., SPE) reduces content by >80%.
Safety Evaluation：Preliminary toxicology shows positive Ames test results, indicating potential mutagenicity. Current standards limit it to ≤0.1 ppm, requiring continuous monitoring via accelerated and long-term stability studies.
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!
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E-mail: anna@molcoo.com
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