Buspirone EP Impurity E, also described as Buspirone Open Ring Impurity, is a structurally defined process-related impurity of the azaspirodecanedione anxiolytic buspirone, CAS 257877-43-3. It corresponds to an open-chain amide-piperazine analogue formed by cleavage or incomplete annulation of the pyrimidinyl piperazinyl scaffold during synthesis or under degradative hydrolytic conditions. The compound has formula C21H33N5O3 and molecular weight 403.52 g/mol. Because of its low-level occurrence and close structural similarity to the parent drug, characterization commonly requires LC-MS/MS, high-resolution MS, and orthogonal RP-HPLC with UV or CAD detection for definitive identification and quantification.
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