N-cyclohexyl-N-phenylnitrous amide;54955-24-7

Product Information

• Product Code：N031286

• English Name：N-cyclohexyl-N-phenylnitrous amide

• English Alias：N-cyclohexyl-N-phenylnitrous amide

• CAS No.：54955-24-7

• Molecular Formula：C??H??N?O

• Molecular Weight：204.27

Advantages

• 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.

Applications

• 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.

Background Description

Research Status

• 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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E-mail: anna@molcoo.com




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