N-nitroso-Duloxetine recall back in the news!

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I completely agree.
I am also curious about how stability evolves, not only for nitrosamine, but also for the other impurities, given that ascorbic acid contributes a degree of acidity and duloxetine is not stable in an acidic environment.
Jaume

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I found that in a recall of Duloxetine, an acceptable limit of 12.5 ppm had been set. If the MDD is 120 mg, this corresponds to 1500 ng. Currently, the CDER page does not display an interim limit for N-nitroso-Duloxetine, and the acceptable limit is listed as 100 ppm. What do you all think?

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