La impureza N-Nitroso Rivaroxaban Open-Ring Acid Impurity | también referida como Rivaroxaban Nitrosamine Impurity I | es una nitrosamina de anillo abierto que puede formarse por nitrosación durante síntesis o degradación del principio activo. Se caracteriza por la presencia de un fragmento ácido abierto y requiere monitoreo específico en el perfil de impurezas. Su identificación y cuantificación se logra mediante HPLC acoplada a MS/MS | espectrometría de alta resolución y confirmación por RMN. Las estrategias de control incluyen optimización del proceso | etapas de purificación dedicadas | límites en especificación y estudios de degradación acelerada para prevenir su formación y acumulación.
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To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
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