Abacavir Impurity 5 es una impureza relacionada con el proceso de síntesis y degradación del principio activo que requiere identificación y cuantificación precisas para asegurar la conformidad regulatoria. Su caracterización incluye determinación de masa exacta mediante LC-MS | perfil cromatográfico por HPLC | espectroscopía y estudios de degradación forzada para definir su origen y rutas de formación. Los métodos analíticos deben ser validados en términos de especificidad | límite de detección | límite de cuantificación | precisión y exactitud. El establecimiento de límites de aceptación y la monitorización en lotes permiten evaluar el impacto sobre la estabilidad y seguridad del producto final y optimizar controles de proceso.
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