Maralixibat Impurity 1 (CAS 228113-63-1) es una impureza relacionada con el proceso detectada en fases de síntesis y en controles de calidad del principio activo; su presencia en niveles traza exige evaluación y establecimiento de límites de especificación claros para garantizar la seguridad y estabilidad del lote. El perfil de impurezas se monitoriza mediante métodos analíticos validados como HPLC y LC-MS y, cuando procede, caracterización estructural por RMN. El control incluye estrategias de reducción en proceso, muestreo dirigido y análisis de degradación forzada para entender su formación y su potencial impacto toxicológico, cumpliendo requisitos regulatorios y de calidad.
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