Hello Nitrosamines teams,
The N-Nitrosonicardipine impurity has been added to the FDA list with a AI 1500ng/d. We have requiered the synthesis of this impurity to 2 suppliers but they are not abble to produce it and proposed us to send a report describing the chemical tests done to synthetise it. As this impurity has been listed do you think that a standard reference is available ? Or it’s only based on the nicardipine structure ? Thanks in advance for your experience on this type of subject.
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This impurity cannot be formed; see the discussion in the related topic:
N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs
Therefore a detailed failure report (including NMR and mass spectra of the other products obtained) should be sufficient.
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Not the first time we have seen that. It may be a good idea for the regulatory agencies to add a vetting process.
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Sciandra,
Yes, this impurity cannot be formed due to the structural arrangements of the molecule. We got FDA acceptance for this communication. You can also proceed by this way.
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