Dear Haresh,
the failing report of Veeprho is based on the nitrosation with NaNO2 and in specific conditions.
It is possible, this compound to be nitrosated under very harsh and special conditions which has no relation with the ‘‘realistic’’ stability conditions through the life-cycle of a drug product.
Furthermore, someone should have been sure about the validity of the reference standard which has been used for the quantification of the results. Sometimes, the simple NMR or MS spectra are not enough and more specific techniques are necessary (like HRMS, HSQC NMR etc).
My personal opinion is that the nitrosation of this amine in the final product would be very difficult, nearly impossible due to the very low nucleophilicity of the targeted nitrogen.
kind regards
Christos
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Synthesis of Nitroso Derivatives of Dihydropyridine Calcium Channel Blockers-New Pub
https://pubs.acs.org/doi/10.1021/acs.oprd.5c00153
Nifedipine, Felodipine, Clevidipine, Lacidipine, Nimodipine, and Nisoldipine are tested in the literature.
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