Lisinopril EP Impurity H (CAS 138247-43-5) es una impureza estructuralmente relacionada con lisinopril que suele originarse por desprolinización parcial o formación de aductos aminoácidos durante la síntesis o almacenamiento; su identificación y cuantificación son críticas para el control de calidad farmacéutico. Caracterización por HPLC con detección UV | LC-MS y RMN permite confirmar masa molecular y patrones de fragmentación | establecer tiempo de retención y determinar límites de aceptación en especificaciones y monografías EP. La evaluación de su perfil toxicológico | estabilidad y comportamiento en procesos de purificación guía la mitigación de riesgos regulatorios y la implementación de procedimientos de liberación robustos.
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