2-Methyl-5-nitro-1-nitroso-1H-imidazole: Synthesis Attempts and Failure Report (NAP Test)

2-Methyl-5-Nitro-1-Nitroso-1H-Imidazole is a nitrosated derivative of imidazole-based compounds, containing both nitro and nitroso functional groups that raise potential concerns about nitrosamine formation and stability under specific conditions.

EMA Guidance on Nitrosamines

According to EMA guidelines, if repeated synthesis attempts fail to detect the formation of nitrosamine impurities, it is likely that the impurity either does not exist or poses an extremely low risk.

Nitrosation

We conducted multiple nitrosation assays under rigorous forced conditions (NAP tests), to evaluate the risk of 2-Methyl-5-nitro-1-nitroso-1H-imidazole formation. Our findings revealed that 2-Methyl-5-nitro-1-nitroso-1H-imidazole does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.

Request Synthesis Failure Report Quote

Our synthesis failure report provides a detailed account of the findings from our synthesis attempts and rigorous testing, demonstrating the non-formation of the nitroso impurity. It offers a comprehensive overview of the evaluated conditions and the resulting data.

2-Methyl-5-nitro-1-nitroso-1H-imidazole Technical Information

• Molecular Weight: – 156.1 g/mol
• Molecular Formula: – C4H4N4O3
• IUPAC Name: – 2-Methyl-5-nitro-1-nitroso-1H-imidazole
• CAS Number: N/A
• Synonyms: N/A

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