Citalopram Impurity 16 (sal de oxalato) | CAS 1217846-85-9 | es una impureza de proceso caracterizada por su formación durante etapas de síntesis y aislamiento del principio activo. Como sal de oxalato presenta propiedades fisicoquímicas y cristalográficas que afectan su identificación y cuantificación en lotes de materia prima | por lo que su perfil debe definirse mediante técnicas analíticas como HPLC | LC-MS y RMN para establecer límite de aceptación y criterios de degradación. El control robusto de esta impureza es esencial para evaluar la calidad del material intermedio y del producto final y para diseñar procedimientos analíticos validados que aseguren conformidad con especificaciones regulatorias.
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