Endotoxins from a Pharmacopoeial Point of View
by
Elvira Franco 1,2,†, Verónica Garcia-Recio 1,†
, Pilar Jiménez 3, Manuel Garrosa 4, Tomás Girbés 3, Manuel Cordoba-Diaz 1,2,* and Damián Cordoba-Diaz 1,2,*
Elvira Franco 1,2,†, Verónica Garcia-Recio 1,†, Pilar Jiménez 3, Manuel Garrosa 4, Tomás Girbés 3, Manuel Cordoba-Diaz 1,2,* and Damián Cordoba-Diaz 1,2,*
1
Pharmaceutics and Food Technology, Complutense University of Madrid, 28040 Madrid, Spain
2
University Institute of Industrial Pharmacy (IUFI), Complutense University of Madrid, 28040 Madrid, Spain
3
Area of Nutrition and Food Sciences, University of Valladolid, 47005 Valladolid, Spain
4
Area of Histology, Faculty of Medicine and INCYL, University of Valladolid, 47005 Valladolid, Spain
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Toxins 2018, 10(8), 331; https://doi.org/10.3390/toxins10080331
Received: 30 June 2018 / Revised: 3 August 2018 / Accepted: 14 August 2018 / Published: 16 August 2018
(This article belongs to the Special Issue Lipopolysaccharide: Bacterial Endotoxin)
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.
View Full-Text
▼
Show Figures
Figure 1
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited
- Supplementary File 1:
PDF-Document (PDF, 687 KB)
MDPI and ACS Style
Franco, E.; Garcia-Recio, V.; Jiménez, P.; Garrosa, M.; Girbés, T.; Cordoba-Diaz, M.; Cordoba-Diaz, D. Endotoxins from a Pharmacopoeial Point of View. Toxins 2018, 10, 331.
Show more citation formats
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.
Search more from Scilit
