Contamination and Impurities
Regulatory Consultations

Rivaroxaban Oxazolidine Open-Ring acid Impurity

Technical Data

CAS Number

482305-98-6

Alternate CAS#

721401-53-2 (R-Isomer)

Molecular Formula

C₁₈H₂₀ClN₃O₄S

Molecular Weight

409.89 g/mol

IUPAC Chemical Name

5-chloro-N-(2-hydroxy-3-((4-(3-oxomorpholino)phenyl)amino)propyl)thiophene-2-carboxamide

Synonyms

Thiophene-2-carboxamide, 5-chloro-N-(2-hydroxy-3-((4-(3-oxomorpholino)phenyl)amino)propyl); Rivaroxaban Amide impurity

USP Name

N/A

EP Name

N/A

Appearance Specifications

Off-white to pale beige solid

Storage Condition

Refrigerator, under inert atmosphere

Material Type

Impurity standard

Melting Point

NA

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