Impureza Diltiazem EP Impurity D (forma base libre) | CAS 86408-45-9 | también conocida como Diltiazem Related Compound D | N-desmetil diltiazem o N-monodemetildiltiazem | representa una degradación y metabolito crítico en el perfil de impurezas del principio activo diltiazem. Su monitorización mediante técnicas analíticas validadas como HPLC con detección UV o LC-MS es esencial para garantizar cumplimiento de especificaciones farmacéuticas y límites de impurezas. Se describen criterios de identificación | retención | espectrometría de masas y pureza por área. El control robusto de lotes | límites de aceptación y métodos de cuantificación permiten mitigar riesgos de estabilidad y seguridad derivados de esta impureza.
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