Prucalopride Succinate Impurity - 1, CAS 1599434-55-5, is a structurally defined related substance of prucalopride, identified as 4-Amino-5-chloro-N-(1-(3-hydroxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide. With molecular formula C17H24ClN3O3 and molecular weight 353.84 g/mol, it represents an amino-chloro dihydrobenzofuran amide impurity consistent with synthetic intermediate carryover or regioselective transformation byproduct. Its presence may inform assessment of process robustness and impurity fate within the active substance. Quantification typically relies on LC-MS/MS and complementary LC-UV methods, with confirmatory high-resolution MS or NMR when structural assignment is required under impurity characterization expectations aligned with ICH M7 principles.
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