AI limit for N-Nitroso Losartan

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:


Thank you so much sir @David

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.