Hi Anita,
You should evaluate each situation individually. Nitrosation does not occur only under ideal pH and temperature conditions; although these factors influence the reaction, nitrosation can still happen outside the optimal range. Because acceptable nitrosamine limits are extremely low, even trace amounts or minor reaction products may require extrapolation of limits.
Each case must be assessed carefully whenever amines and nitrites are present. Consider the amine structure and pKa. For predicting potential formation, the Ashworth et all (2023) article is very helpful, though its temperature assumptions can be limiting.
From a practical standpoint, I’ve seen nitrosamine formation in high pH products, both solid and liquid, and at various manufacturing temperatures. While higher temperatures typically increase formation, I have also observed it in steps controlled at room temperature.
The following topics from community might help
Construction of a modified Arrhenius equation for predicting drug nitrosation in solid dosage form -Pub - New Scientific Knowledge & Development - Nitrosamines Exchange
Berkeley Madonna Software for Nitrosation Kinetic Calculations - Risk Assessment Strategy / Tools & Technology - Nitrosamines Exchange