Impureza Diltiazem Sulphone N-oxide é um derivado oxidado observado no perfil de impurezas de diltiazem. Surge por oxidação do heteroátomo N e de resíduos sulfurados durante síntese | purificação ou armazenamento | exigindo controle estrito. A determinação analítica emprega HPLC com detecção UV para quantificação e LC-MS e RMN para confirmação estrutural | complementada por estudos de estabilidade sob condições aceleradas. Sua presença pode comprometer a pureza e o perfil de segurança do lote | justificando limites de aceitação baseados em ICH Q3A e investigações de vias de formação. Fornecemos material de referência e dados analíticos para suporte à caracterização e qualificação desta impureza.
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