Rivaroxaban N-Nitroso Amide Impurity D5

SZ CAT No:	SZ-R017D04
CAS No	NA
Mol.F.	C18H14D5ClN4O5S
Mol.Wt.	443.9
Inv. Status	Under Synthesis

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Chemical Name: 5-Chloro-N-(2-hydroxy-3-(nitroso(4-(3-oxomorpholino)phenyl)amino)propyl-1,1,2,3,3-d5)thiophene-2-carboxamide

Shipping Temperature: Ambient

HSN Code: 38229010

Country of Origin: India

Smiles: O=C1COCCN1C2=CC=C(N(N=O)C([2H])([2H])C([2H])(O)C([2H])([2H])NC(C3=CC=C(Cl)S3)=O)C=C2

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 N-Nitroso Amide Impurity D5 is chemically 5-Chloro-N-(2-hydroxy-3-(nitroso(4-(3-oxomorpholino)phenyl)amino)propyl-1,1,2,3,3-d5)thiophene-2-carboxamide. Rivaroxaban N-Nitroso Amide Impurity D5 is supplied with detailed characterization data compliant with regulatory guideline. Rivaroxaban N-Nitroso Amide Impurity D5 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.

Rivaroxaban N-Nitroso Amide Impurity D5

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