Forced Degradation and the NAP test

Dear all,
I read so much now I forget where I have seen things, so I am hoping someone can help.
I am sure I read about quenching the excess Sodium Nitrite when carrying out the NAP test in the forced formation of nitrosamines, to give time for sample prep etc. afterwards, but I can’t find the reference any more. Any suggestions?

Modified NAP test.pdf (1.6 MB)

Here are some insights


While assessing the risk, if you end up with lower, or medium level risk, the immediate question is confirmatory testing?.

To avoid the confirmatory testing, it is better to conduct NAPs test & provide greater level of assurance to the assessed risk.

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@MarkS , there are so many articles, and the updating dynamics are truly impressive. Sometimes, we find ourselves wondering, ‘where did I read this?’ Isn’t that true?!

@vsnu999 already shared an example, and I have another one to add: Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs).

I hope you can find the information you’re looking for.