El perfil de impurezas del (S)-Fenilefrina clorhidrato (CAS 939-38-8) se centra en la identificación y cuantificación de impurezas relacionadas | enantiómeras y productos de degradación generados durante la síntesis y el almacenamiento. De especial relevancia es la presencia del enantiómero R y subproductos de oxidación que pueden comprometer la pureza y la seguridad. El control se realiza mediante HPLC quiral para la determinación enantiomérica | LC-MS y RMN para la caracterización estructural | y ensayos de estrés para definir vías de degradación. Las especificaciones | alineadas con ICH Q3A y Q3B | establecen límites | estrategias de mitigación y requisitos de monitorización de solventes residuales y metales traza.
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