Indomethacin Impurity 13 es una impureza relevante en el control de calidad de lotes farmacéuticos derivada de reacciones secundarias o degradación térmica durante síntesis y almacenamiento. Su identificación y cuantificación requieren técnicas analíticas robustas como HPLC con detección UV | LC-MS para determinación de masa y NMR para confirmación estructural. La caracterización completa del perfil de impurezas permite establecer límites de especificación | métodos de muestreo y procedimientos de mitigación en procesos de producción. Estudios de estabilidad forzados y validación analítica son esenciales para evaluar su formación | cinética y posible impacto sobre la seguridad y eficacia del producto final | facilitando cumplimiento regulatorio.
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