RT info:eu-repo/semantics/article
T1 Endotoxins from a pharmacopoeial point of view
A1 Franco, Elvira
A1 García Recio, Verónica
A1 Jiménez López, María del Pilar
A1 Garrosa García, Manuel
A1 Girbés Juan, Tomás
A1 Córdoba Diaz, Manuel
A1 Córdoba Diaz, Damián
K1 Pyrogens
K1 Pirógenos
K1 Parenteral drug products
K1 Medicamentos vía parenteral
K1 3207.06 Endotoxinas
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 http://uvadoc.uva.es/handle/10324/40987
UL http://uvadoc.uva.es/handle/10324/40987
LA eng
NO Toxins, 2018, vol. 10, n. 8. 9 p.
NO Producción Científica
DS UVaDOC
RD 27-dic-2024