La impureza H de Bacitracina EP, también denominada Bacitracina H3 y asociada al CAS 144572-55-4, es una variante lipopeptídica estrechamente relacionada dentro del perfil de impurezas del antibiótico peptídico tipo polimixina. Con fórmula molecular C65H96N16O17S y peso molecular de 1405,6 g/mol, representa microheterogeneidad derivada de la ensambladura peptídica no ribosomal, truncación de cadenas laterales o procesamiento enzimático durante la fermentación y la purificación posterior. Su asignación estructural suele requerir LC-MS/MS, espectrometría de masas de alta resolución y RP-HPLC ortogonal con UV y mapeo peptídico. Su caracterización es pertinente para el perfil de impurezas farmacopeico, ya que cambios secuenciales sutiles alteran el estado de carga, el comportamiento cromatográfico y la comparabilidad de la potencia.
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