Endotoxins from a Pharmacopoeial Point of View.
Toxins (Basel)
; 10(8)2018 08 16.
Article
de En
| MEDLINE
| ID: mdl-30115887
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 pyrogenicitythat 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.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Pharmacopées comme sujet
/
Pyrogènes
/
Dosage biologique
/
Endotoxines
Limites:
Animals
/
Humans
Langue:
En
Journal:
Toxins (Basel)
Année:
2018
Type de document:
Article
Pays d'affiliation:
Espagne