Empagliflozin Methyl Impurity, CAS 333359-90-3, é uma variante estrutural relacionada ao processo do esqueleto da empagliflozina, na qual a substituição metil altera a arquitetura do éter arílico. Com fórmula molecular C20H23ClO6 e massa molecular de 394.85 g/mol, trata-se de uma impureza clorada do tipo oxiglicosídica, formada tipicamente por reações secundárias durante etapas de eterificação ou alquilação na síntese do princípio ativo. Sua avaliação exige caracterização ortogonal por LC-MS/MS, MS de alta resolução e RMN, com separação cromatográfica geralmente por HPLC de fase reversa. No contexto regulatório, é tratada como impureza de processo não mutagênica.
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