Norfloxacin EP Impurity C (Ditrifluoroacetate) é uma impureza identificada no perfil de pureza de norfloxacina | caracterizada como sal de ditrifluoroacetato formado durante etapas de síntese e purificação. Apresenta massa molecular e padrão de fragmentação detectáveis por espectrometria de massas | deslocamento químico específico em 1H e 13C NMR e tempo de retenção distinto em HPLC com fase reversa. Sua presença pode afetar a estabilidade do lote e a conformidade com limites analíticos | exigindo métodos validados para quantificação | limites de aceitação e estratégias de limpeza cromatográfica. Fornecemos dados analíticos e material de referência para suporte ao controle de qualidade.
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