N-Nitroso Osimertinib es el derivado nitrosamina de osimertinib y pertenece a una clase de impurezas de alta relevancia regulatoria, ya que las funciones N-nitroso pueden conferir riesgo mutagénico y potencial carcinogénico. Con fórmula molecular C28H32N8O3 y peso molecular de 528.61 g/mol, su estructura es coherente con la nitrosación del precursor amino terciario durante la síntesis, el almacenamiento o la exposición a agentes nitrosantes. Su evaluación a nivel de traza suele requerir métodos ortogonales de alta sensibilidad como LC-MS/MS y, cuando procede, LC-MS de alta resolución. En el contexto de ICH M7, se considera una impureza potencialmente reactiva con el ADN.
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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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