La impureza Bacitracin Impurity 2 (CAS 668489-48-3) se describe como una impureza relacionada del proceso de fabricación que influye en el perfil de pureza y estabilidad del principio activo; su caracterización exige técnicas analíticas robustas como cromatografía líquida de alta resolución con detección UV | confirmación por espectrometría de masas de alta resolución y | cuando procede | ensayo por LC-MS/MS para cuantificación selectiva. Se asocia a vías de degradación oxidativa y a subproductos de síntesis | presenta un tiempo de retención reproducible frente al estándar y debe controlarse mediante límites de especificación validados | estudios de estabilidad y estrategias de control de proceso conforme a guías ICH.
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