N-cyclohexyl-N-phenylnitrous amide;54955-24-7
Product Code：N031286
English Name：N-cyclohexyl-N-phenylnitrous amide
English Alias：N-cyclohexyl-N-phenylnitrous amide
CAS No.：54955-24-7
Molecular Formula：C₁₂H₁₆N₂O
Molecular Weight：204.27
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), and HRMS, suitable for precise analysis of nitrosamine impurities.
Stability Assurance：Stable for 24 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in acetonitrile solution within 3 months.
Drug Safety Testing：Used for LC-MS/MS detection of nitrosamine impurities in related drugs, complying with ICH M7 guidelines for genotoxic impurity control (≤0.1 ppm).
Process Risk Assessment：Monitors N-cyclohexyl-N-phenylnitrous amide generated from nitrosation side reactions during drug synthesis, reducing impurity levels by optimizing reaction conditions (e.g., avoiding sodium nitrite excess, controlling acidic pH).
Method Validation：Serves as a standard for developing nitrosamine detection methods, verifying sensitivity (LOD down to 0.01 ng/mL) and specificity.
N-nitroso compounds (such as N-cyclohexyl-N-phenylnitrous amide) are prioritized for control by regulatory agencies (FDA, EMA) due to potential genotoxicity and carcinogenicity. These impurities can form during synthesis via reactions between secondary amines and nitrosating agents or accumulate under storage conditions. With the implementation of ICH M7, detection and control of such impurities have become critical for drug quality.
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 0.005 ng/mL for trace analysis.
Formation Mechanism：Originates from the reaction of cyclohexylamine and aniline derivatives with nitrite 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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