RT Journal Article
T1 Endotoxins from a Pharmacopoeial Point of View
A1 Franco Gil, María Elvira
A1 García Recio, Veronica
A1 Jiménez López, Pilar
A1 Garrosa, Manuel
A1 Girbés Juan, Tomás
A1 Córdoba Díaz, Manuel
A1 Córdoba Díaz, Damián
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 2018-08-16
LK https://hdl.handle.net/20.500.14352/12740
UL https://hdl.handle.net/20.500.14352/12740
LA eng
NO Franco Gil, E., García Recio, V., Jiménez López, P. et al. «Endotoxins from a Pharmacopoeial Point of View». Toxins, vol. 10, n.o 8, agosto de 2018, p. 331. DOI.org (Crossref), https://doi.org/10.3390/toxins10080331.
DS Docta Complutense
RD 9 abr 2025