Metoprolol EP Impurity C sal maleato | también referida como Bisoprolol EP Impurity L o Metoprolol Related Compound C | es 4-(2-hidroxi-3-(isopropilamino)propoxi)benzaldehído maleato. Esta impureza aldehídica se genera por degradación oxidativa o por reacciones secundarias durante la síntesis y puede alterar el perfil de pureza del principio activo. Presenta mayor polaridad y solubilidad relativa por el contraión maleato y muestra reactividad típica de aldehídos que exige evaluación cuantitativa. Se recomienda control mediante HPLC-UV complementado con LC-MS y RMN para identificación y cuantificación | establecer límites conforme a ICH Q3A y aplicar medidas de proceso para minimizar su formación.
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