La impureza Thioctic Acid Impurity 15 (CAS 46353-61-1) es un derivado relacionado del ácido tioctico que aparece como subproducto de síntesis o degradación. Presenta propiedades fisicoquímicas próximas al principio activo | lo que dificulta su separación por cromatografía convencional y requiere métodos analíticos sensibles como HPLC con detección por MS | espectroscopía NMR y FTIR para confirmación estructural. Su monitoreo es imprescindible en control de calidad para cumplir límites de especificación y evaluar estabilidad durante procesos y almacenamiento. La gestión incluye optimización de condiciones de reacción | purificación reforzada y establecimiento de límites de aceptación y procedimientos de liberación basados en riesgos.
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