N-Nitroso Abacavir Impurity 1 | también conocido como Abacavir Nitroso 1 | es una impureza N-nitroso relacionada con el proceso de síntesis y la nitrosación del precursor de abacavir. Presenta riesgos potenciales de genotoxicidad a niveles bajos | por lo que su monitorización y control es crítica. Se detecta y cuantifica mediante técnicas sensibles como LC-MS/MS y GC-MS tras extracción y validación de métodos HPLC. El entendimiento de vías de formación | condiciones que favorecen su generación y estrategias analíticas permite establecer límites reglamentarios | controles de proceso y criterios de estabilidad para garantizar la calidad del producto final.
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