N-Nitroso Cyclophosphamide es una impureza nitrosamina relacionada con la nitrosación de precursores amínicos durante la síntesis | formulación o almacenamiento. Presenta preocupación toxicológica por su potencial genotóxico y carcinogénico | por lo que su presencia y niveles deben evaluarse conforme a ICH M7 y guías regulatorias aplicables. Su detección y cuantificación requiere métodos analíticos validados como LC-MS/MS o GC-MS con límites de detección y cuantificación adecuados. Las estrategias de control incluyen eliminación de agentes nitrosantes | control de pH | purificación específica y monitoreo de precursores. Establecer criterios de aceptación y programas de vigilancia garantiza la seguridad y calidad del producto farmacéutico.
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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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