Rivaroxaban

Rivaroxaban Impurities

Rivaroxaban impurities include synthetic intermediates, process-related compounds, degradation products, and nitrosamine contaminants that may arise during synthesis, formulation, or storage. As a direct oral Factor Xa inhibitor used in the prevention and treatment of thromboembolic disorders, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Rivaroxaban EP Impurities

Pharmacopeial and non-pharmacopeial Rivaroxaban impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials include halogenated thiophene derivatives, oxazolidinone analogs, and morpholinyl-based variants, supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Rivaroxaban Related Compounds

Structurally related compounds and synthetic analogs associated with Rivaroxaban are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Rivaroxaban Impurity Reference Standards

Rivaroxaban impurity reference standards are provided with validated analytical data including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.