Impureza de capecitabina 14 (mistura de diastereômeros) é um subproduto sintético frequentemente detectado no perfil de impurezas durante síntese e purificação. Caracteriza-se por pares de diastereômeros com propriedades fisicoquímicas semelhantes que complicam separação e quantificação. Recomendam-se métodos analíticos validados como HPLC com detecção UV e LC-MS para determinação de conteúdo | além de RMN para confirmação estrutural. Estudos de estabilidade e ensaios de pureza ajudam a definir limites especificados conforme guidelines regulatórias. Fornecemos material de referência e dados analíticos para suporte a desenvolvimento de métodos | avaliação de risco e controle de qualidade em loteamento.
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