Abacavir Dinitroso Impurity | também denominada ABCRC-1 Dinitroso Impurity | é uma impureza relacionada ao processo de síntese do princípio ativo abacavir caracterizada por dois grupos nitroso. Esta impureza apresenta elevada reatividade química e potencial risco genotóxico | exigindo monitoramento e controle rigorosos durante desenvolvimento e produção. Métodos analíticos sensíveis como HPLC-UV acoplada a LC-MS/MS são recomendados para identificação | quantificação e estudo de degradação. Estratégias de controle incluem otimização da rota sintética | condições de reação que minimizem formação | etapas de purificação direcionadas e limites de especificação baseados em estudos toxicológicos e orientações regulatórias ICH. Fornece informação crítica para gestão de qualidade do API.
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