N-Nitroso Famotidine EP Impurity A: Synthesis Attempts and Failure Report (NAP Test)

N‑Nitroso Famotidine EP Impurity A is a proposed nitrosamine impurity derived from Famotidine EP Impurity A (a specified related substance in pharmacopeial profiling of famotidine). It contains (or is formed from) a nitrosatable nitrogen that may undergo N‑nitrosation in the presence of nitrosating agents such as nitrite/nitrous acid under acidic conditions.

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 Famotidine EP Impurity A formation. Our findings revealed that N-Nitroso Famotidine EP Impurity A 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 Famotidine EP Impurity A Technical Information

• Molecular Weight: 287.37 g/mol
• Molecular Formula: C8H13N7OS2
• IUPAC Name: (Z)-3-(((2-((diaminomethylene)amino)thiazol-4-yl)methyl)thio)-N’-nitrosopropanimidamide
• CAS Number: N/A
• Synonyms: N/A

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