N-nitroso Solifenacin

Please suggest CPCA score and limit for N-nitroso Solifenacin.

Dear Samir,

I believe that the limit should be 1500 ng/day, according to category 4.

Both nitrogen atoms are tertiary amino groups. They cannot form any nitrosamine.
Did you mean
(Solifenacin EP Impurity A Nitroso Impurity | SynZeal)

1 Like

Please try your best to be more specific and provide additional information when posting questions…


That compound is eagerly waiting to be hydrolized into a secondary amine…

1 Like

Hi Naiffer,

Noted your feedback.
Well understood.

Please note that we intend to know CPCA score and limit for N-nitroso Solifenacin EP impurity A.

1 Like

Hi Samir,
the CPCA score for this impurity (N-nitroso Solifenacin EP impurity A) is 4, so the AI=1500ng/day (Potency category 4).
you can confirm this also through the smart excel software

kind regards

1 Like