Salcaprozate Impurity 2 (CAS 2037-95-8) | identificado también como 1 | 3-benzoxazina-2 | 4-diona | es una impureza heterocíclica que puede originarse por ciclización intramolecular de intermedios durante la síntesis | afectando perfiles de pureza y estabilidad del lote; su presencia exige controles analíticos específicos. Se describe por señales características en NMR | fragmentación en LC-MS y retención definida en HPLC con detección UV o MS | lo que permite cuantificación y rastreabilidad. El establecimiento de límites de especificación | métodos de eliminación en purificación y procedimientos de liberación conformes a guías regulatorias es esencial para mitigar su impacto en la calidad del principio activo.
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