Losartan Impurity 12 (CAS 2353190-33-5) | 5-(Azidomenzyl)-2-butyl-4-cloro-1H-imidazol | es una impureza relacionada con la síntesis y degradación de los derivados de losartán; su identificación y cuantificación son críticas para asegurar la calidad del producto farmacéutico. Se detecta y caracteriza mediante HPLC | LC-MS y RMN para evaluar identidad | pureza y perfiles de fragmentación. Esta impureza puede afectar la estabilidad y el cumplimiento de límites regulatorios conforme a las directrices ICH | por lo que se recomienda establecer controles de proceso | límites aceptables y estudios de degradación forzada junto con documentación analítica robusta para control en desarrollo y liberación de lotes.
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