N-nitroso Vonoprazan AI 96 ng/day- FDA

Limits of Nitrosamines
#1

Dear Nitrosamines Exchange team,

I learnt that FDA has established a limit of 96 ng/day for N-nitroso vonoprazan based on below news. Can anyone help me to know how the limit has been derived, is it based on Read across or Toxicological data driven AI?

😎 Hemos creado el subgrupo LATAM
#2

SMILES: O=S(C3=CN=CC=C3)=O

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SMILES: O=S(C3=CN=CC=C3)=O

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Another potential Nitroso impurity
SMILES: O=NN(CC1=CNC(C2=CC=CC=C2F)=C1)C
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