Endotoxins from a Pharmacopoeial Point of View



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Franco Gil, Elvira and García Recio, Veronica and Jimenez López, Pilar and Garrosa, Manuel and Girbés Juan, Tomás and Córdoba Díaz, Manuel and Córdoba Díaz, Damián (2018) Endotoxins from a Pharmacopoeial Point of View. Toxins, 10 (8). p. 331. ISSN 2072-6651

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Official URL: https://doi.org/10.3390/toxins10080331


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.

Item Type:Article
Uncontrolled Keywords:endotoxins; pyrogens; parenteral drug products; pharmacopoeial test; harmonization
Subjects:Medical sciences > Pharmacy > Dietetics and nutrition
ID Code:70033
Deposited On:03 Feb 2022 12:01
Last Modified:04 Feb 2022 08:54

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