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Toxins 2018, 10(8), 331; https://doi.org/10.3390/toxins10080331

Endotoxins from a Pharmacopoeial Point of View

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
These authors contributed equally to this work.
*
Authors to whom correspondence should be addressed.
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)
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Abstract

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
Keywords: endotoxins; pyrogens; parenteral drug products; pharmacopoeial test; harmonization endotoxins; pyrogens; parenteral drug products; pharmacopoeial test; harmonization
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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.

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