Informações adicionais sobre o Thioctic Acid EP Impurity B
Fármaco de origem
Thioctic Acid
Nome IUPAC
Alpha-hydro-omega-hydroxypoly[sulfanediyl(3-sulfanyl-8-oxooctane-1,8-diyl)] (mixture of thioctic acid polymers)
Sinônimos farmacopeicos
N/A
Outros sinônimos
N/A
Descrição
Thioctic Acid EP Impurity B corresponde a uma espécie oligomérica hidratada, contendo enxofre, associada à degradação do ácido lipóico e/ou à polimerização induzida pelo processo, representada pela notação empírica H2O[C8H14OS2]n e por uma massa da unidade repetitiva de 190.33 n, com contribuição terminal de água de 18.02. Deve ser entendida mais como uma família de oligômeros superiores do que como um composto único e definido. Sua formação é compatível com vias oxidativas, térmicas ou de acoplamento mediado por enxofre durante a fabricação ou o armazenamento. A caracterização exige tipicamente LC-MS/MS, LC-MS de alta resolução e, quando a volatilidade permite, GC-MS, além de resolução cromatográfica frente ao ácido tióctico monomérico e a outras impurezas sulfuradas.
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