Milrinone Impurity 7 (2HCl Salt) es una impureza relacionada que puede generarse durante la síntesis | el tratamiento de salificación o la degradación por humedad y calor. Su identificación y cuantificación requieren técnicas analíticas robustas como HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. Esta impureza afecta la pureza del lote y puede influir en la estabilidad del producto; por ello se recomienda un control mediante optimización de etapas de purificación | ajuste de pH en la salificación y pruebas de estrés acelerado. Los límites de aceptación deben establecerse conforme a guías regulatorias y estudios toxicológicos | y documentarse en el plan de control de calidad.
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