Impureza Milrinona 1 (CAS 99462-32-5) es un subproducto identificado durante la síntesis y el desarrollo del perfil de impurezas de milrinona. Su presencia se controla mediante técnicas analíticas como HPLC y espectrometría de masas para garantizar cumplimiento con especificaciones de calidad. Esta impureza puede formarse por reacciones secundarias o degradación | por lo que su cuantificación y seguimiento en estudios de estabilidad son críticos. Disponibilidad de un estándar de referencia facilita validación de métodos | determinación de límites de aceptación y evaluación del impacto en la pureza global del lote. Documentación analítica y control de proceso minimizan su aparición.
Referencias
Ayres, J. K., & Maani, C. V. (2022, September 6). Milrinone. Retrieved November 4, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK532943/
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