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Título
Endotoxins from a pharmacopoeial point of view
Autor
Año del Documento
2018
Editorial
MDPI
Descripción
Producción Científica
Documento Fuente
Toxins, 2018, vol. 10, n. 8. 9 p.
Resumen
A pyrogen is a substance that causes fever after intravenous administration or inhalation. Gram negative endotoxins are the most important pyrogens to pharmaceutical laboratories. In the International, United States, Japanese and European Pharmacopoeias, there are two official methods to evaluate pyrogenicity—that is, the bacterial endotoxin test, and the pyrogen test. The main objective of this review is to compare the monographs of each test among the different Pharmacopeias, to detect similarities and differences. The former can be considered fully harmonized, and only non-significant differences were detected. The latter, which is the only available assay for some products and formulations to demonstrate apyrogenicity, shows large differences, which should be considered.
Materias Unesco
3207.06 Endotoxinas
Palabras Clave
Pyrogens
Pirógenos
Parenteral drug products
Medicamentos vía parenteral
ISSN
2072-6651
Revisión por pares
SI
Version del Editor
Propietario de los Derechos
© 2018 MDPI
Idioma
eng
Tipo de versión
info:eu-repo/semantics/publishedVersion
Derechos
openAccess
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