N-Nitroso Darolutamide Benzamide Impurity; Synthesis Attempts and Failure Report (NAP Test)

N-Nitroso Darolutamide Benzamide Impurity is a proposed nitrosamine impurity related to a darolutamide benzamide impurity/related substance. The impurity is considered a potential nitrosation product of a nitrosatable amine-containing impurity that, in the presence of nitrosating agents (e.g., nitrite/nitrous acid) under acidic conditions, could form the corresponding N-nitroso derivative.

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 N-Nitroso Darolutamide Benzamide Impurity formation. Our findings revealed that N-Nitroso Darolutamide Benzamide Impurity 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.

N-Nitroso Darolutamide Benzamide Impurity Technical Information

• Molecular Weight: 445.86 g/mol
• Molecular Formula: C19H20ClN7O4
• IUPAC Name: N-((S)-1-(3-(3-carbamoyl-4-chlorophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxyethyl)-1-nitroso-1H-pyrazole-3-carboxamide
• CAS Number: N/A
• Synonyms: N/A

Need a Sample Synthesis Failure Report? Contact us