Alogliptin Related Compound 20 es una impureza relacionada detectada en lotes de alogliptina cuya caracterización es esencial para el control de calidad. Se describe mediante perfil cromatográfico y masas observadas por LC-MS | y su identificación se confirma con técnicas espectroscópicas y comparación frente a estándares cuando están disponibles. Su cuantificación precisa mediante HPLC validado y métodos de degradación forzada permite establecer límites aceptables y evaluar su formación durante síntesis | purificación y almacenamiento. La trazabilidad de la ruta de formación y la evaluación del impacto sobre estabilidad y seguridad son críticas para definir criterios de liberación y medidas de mitigación en desarrollo farmacéutico.
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