Comparative evaluation of pyrogens tests in pharmaceutical products
Autor(a) principal: | |
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Data de Publicação: | 2004 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Microbiology |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822004000100007 |
Resumo: | A comparison of methodologies for detection of pyrogens in pharmaceutical products was performed. The rabbit pyrogen test was optimized and the dose-response curve was obtained for the 2nd International Standard for bacterial endotoxins, establishing 13.81 EU/mL/kg as the concentration of endotoxin necessary to induce a temperature rise of 0.5ºC. The 0.5ºC cut-off was shown to give results that were more compatible with the pyrogenic doses for humans. The Limulus amoebocyte lysate test (LAL) was standardized with gel-clot and chromogenic endpoints, and used for the comparative evaluation of pharmaceutical products showing good agreement. The use of beta-glucan-reactive and non-reactive LAL reagents identified some products with false-positive results. The interference test was carried out and the specifications validated for some new products as the maximum valid dilution. The results emphasized the importance and limitations of the assays recommended for the evaluation of purity and quality control of parenteral medicinal products, improving the existing methodologies in the context of reduction and replacement in the use of animal models. |
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Brazilian Journal of Microbiology |
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Comparative evaluation of pyrogens tests in pharmaceutical productsbacterial endotoxinLimulus amoebocyte lysatepyrogensrabbit pyrogen testA comparison of methodologies for detection of pyrogens in pharmaceutical products was performed. The rabbit pyrogen test was optimized and the dose-response curve was obtained for the 2nd International Standard for bacterial endotoxins, establishing 13.81 EU/mL/kg as the concentration of endotoxin necessary to induce a temperature rise of 0.5ºC. The 0.5ºC cut-off was shown to give results that were more compatible with the pyrogenic doses for humans. The Limulus amoebocyte lysate test (LAL) was standardized with gel-clot and chromogenic endpoints, and used for the comparative evaluation of pharmaceutical products showing good agreement. The use of beta-glucan-reactive and non-reactive LAL reagents identified some products with false-positive results. The interference test was carried out and the specifications validated for some new products as the maximum valid dilution. The results emphasized the importance and limitations of the assays recommended for the evaluation of purity and quality control of parenteral medicinal products, improving the existing methodologies in the context of reduction and replacement in the use of animal models.Sociedade Brasileira de Microbiologia2004-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822004000100007Brazilian Journal of Microbiology v.35 n.1-2 2004reponame:Brazilian Journal of Microbiologyinstname:Sociedade Brasileira de Microbiologia (SBM)instacron:SBM10.1590/S1517-83822004000100007info:eu-repo/semantics/openAccessSilveira,Rosimar L.Andrade,Simone S.Schmidt,Cleber A.Casali,Renata G.Dalmora,Sérgio L.eng2004-11-16T00:00:00Zoai:scielo:S1517-83822004000100007Revistahttps://www.scielo.br/j/bjm/ONGhttps://old.scielo.br/oai/scielo-oai.phpbjm@sbmicrobiologia.org.br||mbmartin@usp.br1678-44051517-8382opendoar:2004-11-16T00:00Brazilian Journal of Microbiology - Sociedade Brasileira de Microbiologia (SBM)false |
dc.title.none.fl_str_mv |
Comparative evaluation of pyrogens tests in pharmaceutical products |
title |
Comparative evaluation of pyrogens tests in pharmaceutical products |
spellingShingle |
Comparative evaluation of pyrogens tests in pharmaceutical products Silveira,Rosimar L. bacterial endotoxin Limulus amoebocyte lysate pyrogens rabbit pyrogen test |
title_short |
Comparative evaluation of pyrogens tests in pharmaceutical products |
title_full |
Comparative evaluation of pyrogens tests in pharmaceutical products |
title_fullStr |
Comparative evaluation of pyrogens tests in pharmaceutical products |
title_full_unstemmed |
Comparative evaluation of pyrogens tests in pharmaceutical products |
title_sort |
Comparative evaluation of pyrogens tests in pharmaceutical products |
author |
Silveira,Rosimar L. |
author_facet |
Silveira,Rosimar L. Andrade,Simone S. Schmidt,Cleber A. Casali,Renata G. Dalmora,Sérgio L. |
author_role |
author |
author2 |
Andrade,Simone S. Schmidt,Cleber A. Casali,Renata G. Dalmora,Sérgio L. |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Silveira,Rosimar L. Andrade,Simone S. Schmidt,Cleber A. Casali,Renata G. Dalmora,Sérgio L. |
dc.subject.por.fl_str_mv |
bacterial endotoxin Limulus amoebocyte lysate pyrogens rabbit pyrogen test |
topic |
bacterial endotoxin Limulus amoebocyte lysate pyrogens rabbit pyrogen test |
description |
A comparison of methodologies for detection of pyrogens in pharmaceutical products was performed. The rabbit pyrogen test was optimized and the dose-response curve was obtained for the 2nd International Standard for bacterial endotoxins, establishing 13.81 EU/mL/kg as the concentration of endotoxin necessary to induce a temperature rise of 0.5ºC. The 0.5ºC cut-off was shown to give results that were more compatible with the pyrogenic doses for humans. The Limulus amoebocyte lysate test (LAL) was standardized with gel-clot and chromogenic endpoints, and used for the comparative evaluation of pharmaceutical products showing good agreement. The use of beta-glucan-reactive and non-reactive LAL reagents identified some products with false-positive results. The interference test was carried out and the specifications validated for some new products as the maximum valid dilution. The results emphasized the importance and limitations of the assays recommended for the evaluation of purity and quality control of parenteral medicinal products, improving the existing methodologies in the context of reduction and replacement in the use of animal models. |
publishDate |
2004 |
dc.date.none.fl_str_mv |
2004-06-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822004000100007 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1517-83822004000100007 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S1517-83822004000100007 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Microbiologia |
publisher.none.fl_str_mv |
Sociedade Brasileira de Microbiologia |
dc.source.none.fl_str_mv |
Brazilian Journal of Microbiology v.35 n.1-2 2004 reponame:Brazilian Journal of Microbiology instname:Sociedade Brasileira de Microbiologia (SBM) instacron:SBM |
instname_str |
Sociedade Brasileira de Microbiologia (SBM) |
instacron_str |
SBM |
institution |
SBM |
reponame_str |
Brazilian Journal of Microbiology |
collection |
Brazilian Journal of Microbiology |
repository.name.fl_str_mv |
Brazilian Journal of Microbiology - Sociedade Brasileira de Microbiologia (SBM) |
repository.mail.fl_str_mv |
bjm@sbmicrobiologia.org.br||mbmartin@usp.br |
_version_ |
1752122200066883584 |