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)
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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…
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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.
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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
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