Buspirone EP Impurity N, also described as Buspirone Related Compound N, corresponds to CAS 257877-44-4 and has molecular formula C22H32N2O4 with molecular weight 388.50 g/mol. Structurally, it is a bis-spiro diketone dimer derived from two buspirone-like azaspiro[4.5]decane units linked through a butanediyl bridge, and is generally regarded as a process-related impurity rather than a hydrolytic degradant. Its occurrence may reflect coupling or over-alkylation events during synthesis of the azaspiro scaffold. Due to its structural similarity to the parent API, identification typically relies on LC-MS/MS and orthogonal LC-UV methods, with NMR confirmation when necessary.
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