Nitrosamine impurity test

[Jeeva_Rajan]

Hi, Nitrosamine impurity formation, required conditions DMF, amines , nitrous acid, sodium nitrate .

In our process we are using DMF solvent only , Its intermediate products,
It’s required to perform NDMA, NDEA test.

[Awad (Dr. Ahmed Mohamed Awad)]

https://www.fda.gov/media/130801/download

https://www.fda.gov/media/131868/download

[Jeeva_Rajan]

Thank you,