Rivaroxaban N-Methylphthalimide Impurity is an aromatic imide-related process impurity associated with the rivaroxaban manufacturing route rather than a pharmacologically active moiety. The material, CAS 550-44-7, corresponds to C9H7NO2 with a molecular weight of 161.16 g/mol and is structurally consistent with N-alkylphthalimide formation from phthalic anhydride derivatives during synthetic protection or amination steps. Because such impurities may reflect incomplete conversion or side-reaction pathways, characterization typically relies on LC-MS/MS, high-resolution MS, and orthogonal HPLC or GC-MS confirmation. Its presence is evaluated within impurity profiling frameworks, including ICH Q3A and related structural elucidation practices.
References
Vimalesvaran, Kavitha, et al. “Role of Rivaroxaban in the Management of Atrial Fibrillation: Insights from Clinical Practice.” Vascular Health and Risk Management, vol. Volume 14, Jan. 2018, pp. 13–21, https://doi.org/10.2147/vhrm.s134394.
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