Hyoscine Butylbromide EP Impurity G (sal bromuro) | CAS 92714-23-3 | es una impureza detectada en etapas de síntesis y formulación del butilbromuro de hioscina; también referida como Apobuscopan y como (9-butyl-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.0(2 | 4)]nonan-7-yl) 2-phenylprop-2-enoate bromide. Requiere perfilado analítico detallado mediante HPLC | LC-MS y RMN para identificación estructural | cuantificación y evaluación de productos de degradación. Su control dentro de especificaciones farmacéuticas y guías ICH es crítico para garantizar seguridad y estabilidad del lote. Se recomiendan límites de aceptación | procedimientos validados y documentación completa de control de calidad.
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