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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

N-Nitroso Rivaroxaban EP Impurity B

● Under Development

Catalogue No.:	VE0027972
CAS No.:	N/A
Mol. Formula:	C16H18N4O6
Mol. Weight:	362.34 g/mol

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Additional information on

Parent drug

Rivaroxaban

IUPAC Name

(R)-N-nitroso-N-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)acetamide

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=C1N(C2=CC=C(N3C(O[C@@]([H])(CN(N=O)C(C)=O)C3)=O)C=C2)CCOC1

InChI

InChI=1S/C16H18N4O6/c1-11(21)20(17-24)9-14-8-19(16(23)26-14)13-4-2-12(3-5-13)18-6-7-25-10-15(18)22/h2-5,14H,6-10H2,1H3/t14-/m1/s1

Description

N-Nitroso Rivaroxaban EP Impurity B is an N-nitroso-class degradation product identified during synthesis and stability studies of rivaroxaban active substance. This polar, low-level impurity exhibits typical nitrosamine reactivity and requires trace-level detection due to potential genotoxicity concerns. Analytical characterization employs sensitive LC-MS/MS, GC-MS after derivatization, and high resolution MS for confirmatory identification and quantification. Control strategies include nitrosation risk assessment, optimized quench steps, reagent selection, and validated cleaning procedures to minimize formation. Stability profiling under forced degradation and storage conditions informs specification setting and routine batch release testing to ensure consistent impurity control.