2H-1,4-Benzoxazine-5,7-dicarboxylic acid, 6-(2-chlorophenyl)-3,4,6,7-tetrahydro-8-methyl-, 5-ethyl 7-methyl ester, 5-Ethyl 7-methyl 6-(2-chlorophenyl)-3,4,6,7-tetrahydro-8-methyl-2H-1,4-benzoxazine-5,7-dicarboxylate, 5-Ethyl 7-methyl 6-(2-chlorophenyl)-8-methyl-3,4,6,7-tetrahydro-2H-1,4-benzo[b][1,4]oxazine-5,7-dicarboxylate, Propofol EP Impurity D
Descripción
Amlodipine Impurity 1 (1222) | CAS 496024-43-2 | es una impureza estructuralmente identificada como 5-etil 7-metil 6-(2-clorofenil)-3 | 4 | 6 | 7-tetrahidro-8-metil-2H-1 | 4-benzoxazina-5 | 7-dicarboxilato | relevante en el control de calidad del amlodipino. Su presencia puede afectar pureza | estabilidad y perfil de degradación del ingrediente farmacéutico activo | por lo que es esencial su cuantificación mediante técnicas analíticas validadas como HPLC con detección UV o LC-MS. Se recomienda establecer límites basados en ICH Q3A y Q3B | incluir patrones de referencia y desarrollar métodos de separación robustos para minimizar riesgos en procesos sintéticos y etapas de purificación.
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