Buspirone EP Impurity D, also designated Buspirone Bispyrimidinylpiperazinylbutyl Ether Impurity (Free Base), CAS 2724726-67-2, is a structurally related process impurity of the anxiolytic azaspirodecanedione buspirone. The molecular formula C24H38N8O and molecular weight 454.6 g/mol indicate a highly nitrogenated ether species consistent with side-chain coupling or alkylation during synthesis or under forcing conditions. Its non-aromatic heterocyclic framework may complicate chromatographic resolution and requires orthogonal characterization by LC-MS/MS, high-resolution MS, and, when needed, NMR confirmation. Because it is not a nitrosamine, ICH M7 genotoxic impurity concerns are limited to structure-based assessment rather than class-based alerts.
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