Comparative evaluation of pyrogens tests in pharmaceutical products

Detalhes bibliográficos
Autor(a) principal: Silveira,Rosimar L.
Data de Publicação: 2004
Outros Autores: Andrade,Simone S., Schmidt,Cleber A., Casali,Renata G., Dalmora,Sérgio L.
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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spelling 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
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