Salbutamol EP Impurity N (Formate Salt) | CAS 149222-15-1 | también conocida como Salbutamol BP Impurity N (Formate Salt) o Albuterol Dimer (Formate Salt) | es un dímero resultante de acoplamiento del salbutamol que se estabiliza como sal de formato. Esta impureza se origina por reacciones de acoplamiento oxidativo durante la síntesis o por degradación en condiciones acuosas y ácidas leves. Su identificación y cuantificación requieren técnicas analíticas avanzadas como LC-MS | HPLC con detectores UV y RMN para confirmar el peso exacto y la estructura. El control se realiza mediante límites especificados | estudios de estabilidad y procedimientos de purificación validados conforme a las guías EP | BP e ICH.
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