2615274-45-6N-Nitroso Adenine: Synthesis Attempts and Failure Report (NAP Test)

N‑Nitroso Adenine is the nitrosated derivative of adenine, a purine nucleobase. It may form when the exocyclic amino group (or other nitrosatable nitrogens) is exposed to nitrosating species such as nitrous acid (generated from nitrite under acidic conditions), making it relevant as a potential nitrosamine‑related impurity in adenine‑containing materials.

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

• Molecular Weight: 164.12 g/mol
• Molecular Formula: C5H4N6O
• IUPAC Name: 9-nitroso-9H-purin-6-amine
• CAS Number: 2615274-45-6
• Synonyms: N/A

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