Rivaroxaban Impurity 60, CAS 73825-95-3, is a defined organic process impurity associated with the synthetic manufacture of rivaroxaban and structurally characterized as a non-nitrosamine heteroaromatic species. Its empirical formula, C19H14N2O5, and molecular weight of 350.33 g/mol indicate a neutral, oxygen-rich aromatic framework that may arise from coupling, cyclization, or over-oxidation events during route synthesis or storage. Because trace-level specification requires discrimination from closely related analogues, assessment commonly relies on LC-MS/MS, high-resolution LC-MS, and orthogonal HPLC-UV methods. In regulatory impurity profiling, such entities are evaluated for impurity fate, degradation behavior, and potential qualification under ICH Q3A and ICH M7 principles.
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