N-Nitroso Eltrombopag Impurity 3: Synthesis Attempts and Failure Report (NAP Test)

N-Nitroso Eltrombopag Impurity 3 is a proposed nitrosamine impurity related to an eltrombopag-associated impurity. The impurity is considered a potential nitrosation product of a nitrosatable amine-containing impurity/related substance 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 Eltrombopag Impurity 3 formation. Our findings revealed that N-Nitroso Eltrombopag Impurity 3 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 Eltrombopag Impurity 3 Technical Information

• Molecular Weight: 273.24 g/mol
• Molecular Formula: C13H11N3O4
• IUPAC Name: 2`-Hydroxy-3`-(1-nitrosohydrazinyl)-[1,1`-biphenyl]-3-carboxylic acid
• CAS Number: N/A
• Synonyms: N/A

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