Description

Rivaroxaban Nitroso Impurity 5 product with CAS: is also known as N-(3-Chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Rivaroxaban Nitroso Impurity 5 is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Rivaroxaban and its related formulations. Moreover,N-(3-Chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.

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