Información adicional sobre el Thioctic Acid EP Impurity B
Fármaco de origen
Thioctic Acid
Nombre IUPAC
Alpha-hydro-omega-hydroxypoly[sulfanediyl(3-sulfanyl-8-oxooctane-1,8-diyl)] (mixture of thioctic acid polymers)
Sinónimos farmacopeicos
N/A
Otros sinónimos
N/A
Descripción
Thioctic Acid EP Impurity B corresponde a una especie oligomérica hidratada que contiene azufre y está relacionada con la degradación del ácido lipoico y/o con la polimerización inducida por el proceso, representada por la notación empírica H2O[C8H14OS2]n y una masa de unidad repetitiva de 190.33 n, con contribución terminal de agua de 18.02. Debe considerarse más una familia de oligómeros superiores que un compuesto único definido. Su formación es coherente con vías oxidativas, térmicas o de acoplamiento mediadas por azufre durante la fabricación o el almacenamiento. La caracterización suele requerir LC-MS/MS, LC-MS de alta resolución y, cuando la volatilidad lo permite, GC-MS, junto con resolución cromatográfica frente al ácido tióctico monomérico y otras impurezas azufradas.
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