Pantoprazole Sulfone N-Oxide | 6-(Difluoromethoxy)-2-[[(3 | 4-dimethoxy-1-oxido-2-pyridinyl)methyl]sulfonyl]-1H-benzimidazole | CAS 953787-55-8 | é uma impureza relacionada ao pantoprazol | caracterizada pela presença do anel benzimidazol substituído com grupo difluorometoxi e um fragmento 3 | 4-dimetoxi-piridínil N-óxido sulfonilado. Esta entidade deve ser monitorada no perfil de impurezas por sua capacidade de surgir por oxidação ou reações de sulfonilação durante síntese | purificação ou armazenamento; a sua presença pode afetar a pureza e exigir investigação por organismos regulatórios. A caracterização exige técnicas ortogonais como LC-MS/HRMS | espectroscopia de RMN e HPLC com detectores UV e de massas | além de padrões de referência para quantificação | estudos de estabilidade e suporte à validação analítica.
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