Rivaroxaban EP Impurity H

Development and validation of stability indicating UPLC method for the determination of Rivaroxaban in bulk and finished products and identification of degradation products by LCMS
By Ali, Syed Mastan; Ramachandran, D.
From Journal of Applicable Chemistry (Lumami, India) (2021), 10(3), 291-301
 
Validated LC-​MS​/MS method for the determination of three genotoxic impurities in rivaroxaban drug substance
By Korlakunta, Vijaya Gouri; Dasari, Vijaya Bharathi; Sharma, Hemant Kumar; Nowduri, Annapurna; Bonige, Kishore Babu; Chavakula, Ramadas
From European Journal of Biomedical and Pharmaceutical Sciences (2020), 7(8), 492-500
 
Development of a stability-​indicating HPLC method and a dissolution test for rivaroxaban dosage forms
By Souri, Effat; Mottaghi, Siavash; Zargarpoor, Mohammad; Ahmadkhaniha, Reza; Jalalizadeh, Hassan
From Acta Chromatographica (2016), 28(3), 347-361

Rivaroxaban EP Impurity H is chemically 4,5-dichloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide (as per EP); (S)-4,5-Dichloro-N-({2-oxo-3-[4-(3-oxomorpholino)phenyl]oxazolidin-5-yl}methyl)thiophene-2-carboxamide (as per USP). It is also known as Rivaroxaban USP Related Compound H. Rivaroxaban EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Rivaroxaban EP Impurity H can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Rivaroxaban.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.