N-Nitroso vonoprazan

Limits of Nitrosamines
1

I am planning to develop a generic version of vonoprazan. As is well known, the FDA announced an acceptable intake limit of 96 ng/day for N-Nitroso-Vonoprazan, and this limit was derived using a read-across analysis with NDMA as a surrogate.

Could you explain why NDMA was selected as the surrogate compound in this read-across assessment?

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Dear Joann,

with a look, in the N-nitrosovoloprazan, the substitute group on the pyrrole ring is the -CH2N(NO)CH3 which is similar to NDMA.

Is notable, that the CPCA result to AI of 18ng/day. So, the choice of using NDMA as a surrogate molecule is a better alternative.

thanks

Christos

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