N-Nitroso N-desmethyl Osimertinib; Synthesis Attempts and Failure Report (NAP Test)

N-Nitroso N-desmethyl Osimertinib is a proposed nitrosamine impurity related to N-desmethyl osimertinib, an osimertinib-related impurity/metabolite. The desmethyl impurity introduces or exposes a nitrosatable amine 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 N-desmethyl Osimertinib formation. Our findings revealed that N-Nitroso N-desmethyl Osimertinib does not readily undergo nitrosation under the expected conditions, significantly reducing concerns about its potential formation.

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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 N-desmethyl Osimertinib Technical Information

• Molecular Weight: 514.58 g/mol
• Molecular Formula: C27H30N8O3
• IUPAC Name: N-(2-((2-(dimethylamino)ethyl)(nitroso)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide
• CAS Number: N/A
• Synonyms: N/A

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