Nitroso lisinopril

Dear nitrosamine team,

We have received a notification letter from lisinopril API supplier, including Deletion of N-nitroso-lisinopril control in specification for the final substance .

This is according to latest EMA acceptance intake guidance.

Do i need to perform any evaluation before accepting the notification?

Thank you

Dear sbasaleh,
do they have justify their action?
Did they share with you batch analysis results which could justify the omitting if this control? (results <10% of the specification limit).
kind regards

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Dear all,
in the latest revision of the EMA Acceptables Intakes (1st May 2024), N-nitroso Lisinipril has been reclassified as Non-Mutagenic Impurity (NMI). The justification was:

Limit derived using structure-activity-relationship and physicochemical features of N-nitroso-lisinopril, N-nitroso-quinapril and N-nitroso-quinaprilat

We could agree or not (e.g. why only nitroso-Lisinopril and not all the ACE inibhithors with a similar structure?), but this remains an official EMA decision.


Dear Giovanni,
you are absolute right, thank you.
And this justification is, hopefully, a first step for the justification of higher limits for a lot of NDSRIs