Endotoxins from a Pharmacopoeial Point of View

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Publication:
Endotoxins from a Pharmacopoeial Point of View

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toxins-10-00331-v3.pdf (1.01 MB)

Official URL

https://doi.org/10.3390/toxins10080331

Publication Date

2018-08-16

Authors

Franco Gil, Elvira

García Recio, Veronica

Jimenez López, Pilar

Garrosa, Manuel

Girbés Juan, Tomás

Córdoba Díaz, Manuel

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Google Scholar ID

Córdoba Díaz, Damián

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Publisher

MDPI

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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.

UCM subjects

Dietética y nutrición (Farmacia)

URI

https://hdl.handle.net/20.500.14352/12740

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