How much Amine and Nitrating agent "Stoichiometric Ratio" required for formation of Nitrosamine impurities?

Risk Assessment Strategy / Tools & Technology
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Hi,

During the chemical reaction, how much Amine (2 and 3) and Nitrating agent “Stoichiometric ratio” is required for formation of Nitrosamine impurities like NDMA, NDEA, NDSRIs, etc. in Drug Substance and Drug Product.

The answer to the above question will help in identifying the risk of forming Nitrosamine Impurities and whether analysis is required.

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For Information Ideal Example:How to Find the Number of Moles Needed to React | Sciencing

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Dear @DinkarGagare,
I would like to refer to S.S.Mirvish’s article Sci-Hub | JNCI: Journal of the National Cancer Institute | 10.1093/jnci/44.3.633
According to it, to form 1 mole of nitrosamine, 1 mole of amine and 1 mole of N2O3 need to react with each other. But to form 1 mole of N2O3, e.g. 2 moles of nitrite anions need to react with each other.

To sum up, in the usual case, at pH>1, to form 1 mole of nitrosamine, you need 1 mole of amine and 2 moles of nitrite anions. So, the maximum amount of nitrosamine that can be formed under given circumstances will be dictated by the amount of available amine, or amount of available nitrite divided by 2, whichever is lower.

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Thanks for reply, further i will check and update same.