2024-03-28T09:16:17Zhttp://uvadoc.uva.es/oai/requestoai:uvadoc.uva.es:10324/409872023-03-17T11:34:24Zcom_10324_1181com_10324_931com_10324_894col_10324_1387
Endotoxins from a pharmacopoeial point of view
Franco, Elvira
García Recio, Verónica
Jiménez López, María del Pilar
Garrosa García, Manuel
Girbés Juan, Tomás
Córdoba Diaz, Manuel
Córdoba Diaz, Damián
Producción Científica
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.
2020-06-03
2020-06-03
2018
info:eu-repo/semantics/article
Toxins, 2018, vol. 10, n. 8. 9 p.
2072-6651
http://uvadoc.uva.es/handle/10324/40987
10.3390/toxins10080331
eng
https://www.mdpi.com/2072-6651/10/8/331
info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc-nd/4.0/
© 2018 MDPI
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