La impureza N-Nitroso Osimertinib Cloro es un derivado nitrosado detectado en lotes de materia prima y productos intermedios que exige control riguroso debido a su potencial genotóxico. Caracterizada por la presencia del grupo nitroso y un átomo de cloro, su identificación y cuantificación se realizan preferentemente por cromatografía líquida acoplada a espectrometría de masas y técnicas de alta resolución que ofrecen sensibilidad y selectividad necesarias. Su inclusión en especificaciones está guiada por evaluaciones toxicológicas y normativa sobre impurezas genotóxicas. Programas de control de calidad, validación analítica y estudios de estabilidad son esenciales para gestionar niveles y asegurar conformidad regulatoria.
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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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The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
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