Prucalopride Succinate Impurity - 4, also designated Prucalopride-N-Oxide or Prucalopride Impurity C, is a defined oxidative impurity associated with the prucalopride synthetic profile and handling history. With CAS 1900715-98-1, formula C18H26ClN3O4, and molecular weight 383.87 g/mol, it represents N-oxidation of the pyridine-like heteroaromatic nitrogen within the active substance scaffold. Formation is consistent with aerial oxidation, peroxidic stress, or impurity carryover during manufacture. Because N-oxide species may alter polarity and chromatographic behavior, characterization commonly requires LC-MS/MS, high-resolution LC-MS, and sometimes NMR confirmation.
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