(3R,5R)-3,5-Dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-2-methylbutanoyl]oxy]- 1, 2, 6, 7, 8, 8a-hexahydronaphthalen-1-yl]heptanoic acid sodium salt
Sinônimos
Pravastatin BP Impurity A; 6′-epi Pravastatin; (6R)-Pravastatin
Descrição
A Impureza EP A da pravastatina, sal de sódio, CAS 81176-41-2, corresponde à 6′-epi pravastatina, o análogo epimérico em C-6′ do esqueleto de ácido hidroxilado das estatinas. Com fórmula molecular C23H35NaO7 e massa molar de 446.51 g/mol, trata-se de uma inversão estereoquímica no centro portador de hidroxila da cadeia lateral, sem alteração da composição elementar. A epimerização pode ocorrer durante a rota semissintética, sob estresse ácido ou térmico e em armazenamento prolongado em solução. A detecção e a quantificação normalmente exigem LC em fase reversa, LC-MS/MS e separação quiral para resolver a sobreposição entre isômeros e confirmar a atribuição da impureza.
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