O-Dealquilado Belumosudil sulfato é uma impureza de processo crítica que resulta da desalcilaçao O durante etapas de síntese, degradação térmica ou exposição a condições oxidativas. Caracteriza-se por massa molecular e padrões de fragmentação distintos detectáveis por LC-MS e por um deslocamento de pico em HPLC com detecção UV. Sua presença pode comprometer a pureza do lote, alterar perfil farmacocinético e exigir investigação toxicológica dependendo do nível. Boas práticas recomendam rastreamento no perfil de impurezas, validação de métodos analíticos específicos como HPLC e LC-MS, estabelecimento de limites conforme ICH Q3A e implementação de controles de processo e purificação para minimizar formação.
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