N-Nitroso Finerenone: Synthesis Attempts and Failure Report (NAP Test)

N‑Nitroso Finerenone is a proposed nitrosamine impurity related to finerenone, a non‑steroidal mineralocorticoid receptor antagonist. It represents a potential N‑nitroso derivative that could form if a nitrosatable nitrogen within finerenone‑related structures is exposed to nitrosating agents (e.g., nitrite/nitrous acid), most commonly under acidic conditions during processing or in gastric‑like environments.

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 Finerenone formation. Our findings revealed that N-Nitroso Finerenone 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 Finerenone Technical Information

• Molecular Weight: 407.43 g/mol
• Molecular Formula: C21H21N5O4
• IUPAC Name: (S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1-nitroso-1,4-dihydro-1,6-naphthyridine-3-carboxamide
• CAS Number: N/A
• Synonyms: N/A

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