Lisinopril EP Impurity I (CAS 927819-64-5) | también conocida como N-Alkyl Lisinopril | es una impureza sintética observada en el proceso de fabricación de lisinoprilo. Químicamente relacionada con el principio activo | presenta modificaciones en la cadena alcalil que afectan su polaridad y comportamiento cromatográfico. Su identificación y cuantificación por HPLC-MS/MS y técnicas de espectrometría de masas es crítica para el control de calidad y el cumplimiento de límites de la Farmacopea Europea. La presencia de esta impureza puede indicar rutas secundarias de reacción o condiciones de síntesis subóptimas y requiere perfilado | límites especificados y estudios de estabilidad para garantizar seguridad y calidad del lote.
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