General Information

Rivaroxaban Impurities and Rivaroxaban  

Daicel Pharma provides synthesis for Rivaroxaban impurity standards such as 5-chloro-N-methylthiophene-2-carboxamide, Rivaroxaban impurity B, Rivaroxaban Metabolite 5, Rivaroxaban EP impurity H, Rivaroxaban EP impurity F, Rivaroxaban EP impurity B, RVX III Impurity 5, and more. These impurities are crucial for Rivaroxaban quality, efficiency, safety, and stability. Furthermore, Daicel offers a custom synthesis of Rivaroxaban impurities and delivers them globally according to the client’s requirements.

Rivaroxaban [CAS: 366789-02-8] is a monocarboxylic acid amide and is an anticoagulant. Rivaroxaban is the first orally active direct factor Xa inhibitor. It prevents stroke and venous embolism.

Rivaroxaban: Use and Commercial Availability 

Rivaroxaban prevents venous thromboembolic events (VTE) in patients with total hip or knee replacement surgery; to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation; to treat deep vein thrombosis (DVT) and pulmonary embolism (PE); and to reduce the risk of recurrent DVT and or PE. This drug is available under the tradename of Xarelto.

Rivaroxaban Structure and Mechanism of Action

The chemical name of Rivaroxaban is 5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide. Its chemical formula is C₁₉H₁₈ClN₃O₅S, and its molecular weight is approximately 435.9 g/mol.

Rivaroxaban selectively blocks the active site of Factor Xa and helps in the blood coagulation process.

Rivaroxaban Impurities and Synthesis

Rivaroxaban is an anticoagulant medication used to prevent blood clot formation. Like many pharmaceutical compounds, it may contain impurities that can impact its quality and efficacy. They can include related compounds, process-related, and potential genotoxic impurities. The synthesis¹ of Rivaroxaban involves a complex multi-step process, including the reaction of various intermediates with reagents, followed by purification steps to isolate the active pharmaceutical ingredient.

Daicel Pharma provides a Certificate of Analysis (CoA) of Rivaroxaban impurity standards such as 5-chloro-N-methylthiophene-2-carboxamide, Rivaroxaban impurity B, Rivaroxaban Metabolite 5, Rivaroxaban EP impurity H, Rivaroxaban EP impurity F, Rivaroxaban EP impurity B, RVX III Impurity 5, and more. Our CoA is from a cGMP-compliant analytical facility and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity. If requested, we give additional characterization data, such as 13C-DEPT. Daicel Pharma can provide unknown Rivaroxaban impurities or degradation products.