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550-44-7Rivaroxaban N-Methylphthalimide Impurity

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Catalogue No.:	VE009341
CAS No.:	550-44-7
Mol. Formula:	C9H7NO2
Mol. Weight:	161.16 g/mol

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Additional information on CAS 550-44-7

Parent drug

Rivaroxaban

IUPAC Name

2-Methylisoindole-1,3-dione

Synonyms

N/A

Smiles

O=C1N(C)C(C2=C1C=CC=C2)=O

Description

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. ‌