Dear Team, I would appreciate your input and direction regarding the establishment of the N-Nitroso losartan limit. The API structure is provided below.
As an aromatic N-nitroso compound, not a nitrosamine, this is outside the scope of the CPCA and, it can be argued, due to the impossibility of the diazonium ion being formed (necessary for cohort-level potency [Snodin et al]) should be considered outside the cohort entirely.
See earlier discussions on similar structures, for example here on imidazoles: https://nitrosamines.usp.org/t/imidazole-is-a-secondary-amine/6118
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As per CPCA approach this compound fall under potency category 5 with AI 1500 ng/day.
It is outside CPCA, this kind of compounds are clearly indicated in EMA Q&A as not applicable.
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