Capecitabine Impurity 5 é um subproduto identificado durante a síntese e purificação de princípios ativos relacionados à capecitabina | caracterizado por sua estrutura e propriedades físico-químicas distintas que exigem avaliação rigorosa. A presença desta impureza pode derivar de reações de desproteção incompletas | isomerização ou oxidação durante etapas de síntese e armazenamento. A quantificação é realizada por HPLC acoplado a detectores UV e LC-MS para confirmação de massa | complementada por RMN para elucidação estrutural. Seu controle é crítico para garantir conformidade com limites de impurezas especificados em diretrizes regulatórias ICH e para orientar estratégias de purificação | validação de métodos analíticos e estudos de qualificação.
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