La impureza hidroxi de alogliptina es un subproducto de oxidación observado durante la síntesis y en estudios de estabilidad | relevante para el perfil de impurezas y el control de calidad analítico. Su caracterización estructural y cuantificación precisa se realizan mediante técnicas como HPLC | LC-MS y RMN para asegurar cumplimiento de especificaciones y límites de aceptación. La identificación temprana permite ajustar condiciones de proceso | agentes oxidantes y etapas de purificación para minimizar su formación. Estudios de degradación forzada y validación de métodos analíticos garantizan sensibilidad y selectividad adecuadas | apoyando la vigilancia continua del riesgo de impurezas en lote y en estabilidad.
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