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Separation of Rivaroxaban and its Organic Impurities per USP Monograph
In this technical note, we report the separation of Rivaroxaban from its organic impurities per the USP monograph using a Luna™ Omega 3 µm C18 column as an alternative L1 column to a ZORBAX® Eclipse® 3.5 µm XDB-C18 column originally used to elucidate the monograph. The allowable adjustments pertaining to gradient separations are highlighted together with the necessary calculations that are required for the adjusted method conditions to remain compliant with the original monograph.
Separation of Rivaroxaban and its Organic Impurities per USP Monograph
In this technical note, we report the separation of Rivaroxaban from its organic impurities per the USP monograph using a Luna™ Omega 3 µm C18 column as an alternative L1 column to a ZORBAX® Eclipse® 3.5 µm XDB-C18 column originally used to elucidate the monograph. The allowable adjustments pertaining to gradient separations are highlighted together with the necessary calculations that are required for the adjusted method conditions to remain compliant with the original monograph.