Buspirone EP Impurity C, also designated Buspirone bispyrimidinylpiperazinyl butane impurity, is a structurally related process impurity of the anxiolytic piperazine derivative buspirone. CAS 257877-45-5 corresponds to the molecular entity C20H30N8 with a molecular weight of 382.51 g/mol. The compound represents an overalkylated or side-chain homologation product consistent with synthetic coupling or alkylation pathways rather than a primary oxidative degradant. Its polar, polybasic heteroaromatic framework demands orthogonal characterization by LC-MS/MS, high-resolution LC-MS, and, where feasible, NMR confirmation. In regulatory impurity profiling, such a species is evaluated as a specified organic impurity under pharmacopeial and ICH impurity-control expectations.
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