Impureza Dinitroso-Methyl piperazine Gatifloxacin (CAS 55556-94-0) | conocida también como 2-methyldinitrosopiperazine o 2-methyl-N | N’-dinitrosopiperazine | es un subproducto nitrosado relevante en el perfil de impurezas de Gatifloxacina. Su estructura N-nitrosada la categoriza como posible impureza genotóxica | por lo que requiere control riguroso a niveles traza. Se detecta y cuantifica mediante métodos analíticos sensibles como LC-MS/MS y GC-MS tras derivatización | con confirmación por NMR y HPLC cualitativa. Su formación está asociada a reacciones de nitrosación de aminas secundarias durante la síntesis o almacenamiento. Las estrategias de control incluyen optimización del proceso | agentes atrapantes de nitrosantes y procedimientos de purga y validación analítica.
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