Hello all,
we all aware about Nitroso Betahistine, but i would like to know if anyone has worked on Nitroso Betahistine Impurity C?
Structure of both the NDSRIs are pasted below.
Do we need to evaluate Nitroso Impurity C in our formulation?
@Chirag do you have solid evidence of existence of these structures or simply reference from a vendor website?
The potential of nitrosation of impurity C needs to be evaluated theoretically, as a tertiary amine. As an impurity of a much more reactive secondary amine/Betahistine, it is not expected to raise a risk to form the nitroso derivative in the drug product.
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