RT info:eu-repo/semantics/article T1 endotoxins from a pharmacopoeial point of view A1 Franco, Elvira A1 Garcia-Recio, Verónica A1 Jiménez, Pilar A1 Garrosa García, Manuel A1 Girbés, Tomás A1 Cordoba-Diaz, Manuel A1 Cordoba-Diaz, Damián K1 endotoxins K1 pyrogens K1 parental drug products K1 pharmacopoeial test K1 harmonization AB 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. PB MDPI SN 2072-6651 YR 2018 FD 2018 LK https://uvadoc.uva.es/handle/10324/64335 UL https://uvadoc.uva.es/handle/10324/64335 LA eng NO Toxins 2018, 10, 331 NO Producción Científica DS UVaDOC RD 13-mar-2025