Endotoxins from a Pharmacopoeial Point of View
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 py...
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| Format: | Article |
| Language: | English |
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MDPI AG
2018-08-01
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| Series: | Toxins |
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| Online Access: | http://www.mdpi.com/2072-6651/10/8/331 |
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| author | Elvira Franco Verónica Garcia-Recio Pilar Jiménez Manuel Garrosa Tomás Girbés Manuel Cordoba-Diaz Damián Cordoba-Diaz |
| author_facet | Elvira Franco Verónica Garcia-Recio Pilar Jiménez Manuel Garrosa Tomás Girbés Manuel Cordoba-Diaz Damián Cordoba-Diaz |
| author_sort | Elvira Franco |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T00:27:06Z |
| format | Article |
| id | doaj.art-c3b6e8e2f509452ca69400b4f37e7a22 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-04-13T00:27:06Z |
| publishDate | 2018-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-c3b6e8e2f509452ca69400b4f37e7a222022-12-22T03:10:34ZengMDPI AGToxins2072-66512018-08-0110833110.3390/toxins10080331toxins10080331Endotoxins from a Pharmacopoeial Point of ViewElvira Franco0Verónica Garcia-Recio1Pilar Jiménez2Manuel Garrosa3Tomás Girbés4Manuel Cordoba-Diaz5Damián Cordoba-Diaz6Pharmaceutics and Food Technology, Complutense University of Madrid, 28040 Madrid, SpainPharmaceutics and Food Technology, Complutense University of Madrid, 28040 Madrid, SpainArea of Nutrition and Food Sciences, University of Valladolid, 47005 Valladolid, SpainArea of Histology, Faculty of Medicine and INCYL, University of Valladolid, 47005 Valladolid, SpainArea of Nutrition and Food Sciences, University of Valladolid, 47005 Valladolid, SpainPharmaceutics and Food Technology, Complutense University of Madrid, 28040 Madrid, SpainPharmaceutics and Food Technology, Complutense University of Madrid, 28040 Madrid, SpainA 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.http://www.mdpi.com/2072-6651/10/8/331endotoxinspyrogensparenteral drug productspharmacopoeial testharmonization |
| spellingShingle | Elvira Franco Verónica Garcia-Recio Pilar Jiménez Manuel Garrosa Tomás Girbés Manuel Cordoba-Diaz Damián Cordoba-Diaz Endotoxins from a Pharmacopoeial Point of View Toxins endotoxins pyrogens parenteral drug products pharmacopoeial test harmonization |
| title | Endotoxins from a Pharmacopoeial Point of View |
| title_full | Endotoxins from a Pharmacopoeial Point of View |
| title_fullStr | Endotoxins from a Pharmacopoeial Point of View |
| title_full_unstemmed | Endotoxins from a Pharmacopoeial Point of View |
| title_short | Endotoxins from a Pharmacopoeial Point of View |
| title_sort | endotoxins from a pharmacopoeial point of view |
| topic | endotoxins pyrogens parenteral drug products pharmacopoeial test harmonization |
| url | http://www.mdpi.com/2072-6651/10/8/331 |
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