Pruebas de referencia y orientación normativa
Los promotores y solicitantes de medicamentos deben proponer especificaciones (es decir, atributos, procedimientos analíticos y criterios de aceptación) para los excipientes, las sustancias farmacéuticas y los productos farmacéuticos en sus solicitudes. Estas especificaciones deben cumplir las normas de calidad de la Farmacopea de los Estados Unidos/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 farmacéuticos acabados. 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.
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- Separation of L-Methionine, Pharmaceutical Secondary Standard; Certified Reference Material
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- Compendial methods from the USP (United States Pharmacopeia) are widely used in pharmaceutical drug product and raw materials testing. However, not all methods in the USP use modern technologies. In chromatographic methods, it is not uncommon that older brands of columns are specified. Therefore, the USP methods are under continuous revision to improve existing procedures or to allow the user to obtain better results.
- Elemental impurities in pharmaceutical drugs present a risk to human health and are regulated. Milli-Q® ultrapure water purification systems comply with the requirements for trace element analyses.
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Protocolos relacionados
- An MS-compatible alternative to the USP and EP methods, with improved specificity and reduced analysis time.
- Separation of Prednisolone, pharmaceutical secondary standard; traceable to USP, PhEur and BP
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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
Al explorar las tendencias y los principales desafíos a los que se enfrenta la comunidad de análisis farmacéuticos y control de calidad, surgieron cuatro puntos clave de esta encuesta
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