Pruebas de referencia y orientación normativa
Los promotores y solicitantes de autorización de medicamentos deben proponer especificaciones (es decir, atributos, procedimientos analíticos y criterios de aceptación) para los excipientes, las sustancias farmacéuticas y los medicamentos en sus solicitudes.
Estas especificaciones deben cumplir las normas de calidad de la Farmacopea de los Estados Unidos o el Formulario nacional (USP/NF), la Farmacopea británica (BP), la Farmacopea europea (EP) o la Farmacopea japonesa (JP).
Las pruebas de referencia de las farmacopeas son protocolos normalizados para muchas materias primas y productos acabados farmacéuticos. Las pruebas y el cumplimiento de estas normas detalladas en los métodos de referencia constituyen un requisito básico para la fabricación, la liberación y la distribución mundiales de principios y especialidades farmacéuticos.
Hable hoy con un experto y obtenga más ayuda sobre las pruebas de referencia y el cumplimiento de los requisitos normativos.
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- This paper illustrates the setting up of a Lopinavir assay following European pharmacopoeia guidelines (10.2), and using a shorter column packed with smaller particles. The described assay saves valuable time and improves separation efficiency, which typically translates to better method performance.
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Destacados
Desde el desarrollo hasta la liberación del fármaco, este PDF interactivo describe una gama de filtros y reactivos fiables y uniformes para el protocolo de análisis de disolución
En esta presentación se ofrece una visión general de alto nivel de los valores específicos de las normas farmacopeicas.
Aprenda estrategias para mejorar la productividad y reducir los costes en sus análisis farmacéuticos con la adaptación del método U/HPLC.
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