Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033 |
Resumo: | Introduction: Research, one of the core areas of health surveillance, has its importance justified by its search for answers to various health problems. Heparin, a biological product with anticoagulant and antithrombotic properties, has been related to adverse events between the years 2007–2008. Because of that, the official compendiums updated the monograph for raw material. However, there is a lack of monographs that evaluate the final product. Objective: The goal of this study is to propose a physicochemical method of analysis of the limits of galactosamine in total hexosamine from the finished product of porcine sodium heparin. Method: We developed an analytical method from the ionexchange high performance liquid chromatography with amperometric detection, with the appropriate evaluations of the system suitability for posterior analysis of three samples of porcine sodium heparin previously submitted to the sample preparation protocol through the Micro Bio-Spin column. Results: The samples were compared to the solution of the system suitability and raw material of porcine sodium heparin. We could detect the presence of galactosamine in one of the three analyzed samples in lower amounts than the limit stipulated by the American pharmacopeia. Conclusions: We concluded that the aforementioned method is efficient for the analysis of the finished product and that is the reason why it will be suggested to the Brazilian pharmacopeia. |
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Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samplesAnálise de limite de galactosamina em hexosaminas totais em amostras injetáveis de heparina sódica suínaHeparinQuality ControlHigh Pressure Liquid ChromatographyHealth SurveillanceHeparinaControle de QualidadeCromatografia Líquida de Alta PressãoVigilância SanitáriaIntroduction: Research, one of the core areas of health surveillance, has its importance justified by its search for answers to various health problems. Heparin, a biological product with anticoagulant and antithrombotic properties, has been related to adverse events between the years 2007–2008. Because of that, the official compendiums updated the monograph for raw material. However, there is a lack of monographs that evaluate the final product. Objective: The goal of this study is to propose a physicochemical method of analysis of the limits of galactosamine in total hexosamine from the finished product of porcine sodium heparin. Method: We developed an analytical method from the ionexchange high performance liquid chromatography with amperometric detection, with the appropriate evaluations of the system suitability for posterior analysis of three samples of porcine sodium heparin previously submitted to the sample preparation protocol through the Micro Bio-Spin column. Results: The samples were compared to the solution of the system suitability and raw material of porcine sodium heparin. We could detect the presence of galactosamine in one of the three analyzed samples in lower amounts than the limit stipulated by the American pharmacopeia. Conclusions: We concluded that the aforementioned method is efficient for the analysis of the finished product and that is the reason why it will be suggested to the Brazilian pharmacopeia.Introdução: A pesquisa, uma das vertentes da vigilância sanitária, tem sua importância justificada pela busca de respostas aos diversos prejuízos relativos à saúde. A heparina, produto biológico com propriedades anticoagulantes e antitrombóticas, esteve relacionada com eventos adversos entre 2007 e 2008. Diante do ocorrido, os compêndios oficiais atualizaram a monografia para matéria-prima. No entanto, há uma deficiência de monografias para avaliação do produto final. Objetivo: Propor método físico-químico de análise de limite de galactosamina em hexosaminas totais a partir do produto acabado de heparina sódica suína. Método: Foi desenvolvido método analítico a partir da cromatografia líquida de alta eficiência por troca iônica e detecção amperométrica, com as devidas avaliações de adequação do sistema para posterior análise de três amostras de heparina sódica suína, as quais foram previamente submetidas ao protocolo de preparo de amostra através da coluna Micro Bio-Spin™. Resultados: As amostras foram comparadas com a solução de adequação do sistema e matéria-prima de heparina sódica suína, sendo possível detectar presença de galactosamina em uma das três amostras analisadas em quantidade inferior ao limite estipulado pela Farmacopeia Americana. Conclusões: Conclui-se que o método é eficiente para análise do produto acabado e, por isso, será sugerido à Farmacopeia Brasileira.Instituto Nacional de Controle de Qualidade em Saúde2018-05-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/103310.22239/2317-269X.01033Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 2 (2018): May; 61-66Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 2 (2018): Puede; 61-66Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 2 (2018): Maio; 61-662317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033/447https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033/485Copyright (c) 2018 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessSantana, Andreza da Costa deMarinho, Anna Carolina MachadoLima, Patrícia Condé deLeitão, Ozéias de LimaFonseca, Debora AlvesTeixeira, Raíssa Laminda Conceição, Claudia MariaJacob, Silvana do Couto2023-06-27T15:10:49Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1033Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:10:49Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples Análise de limite de galactosamina em hexosaminas totais em amostras injetáveis de heparina sódica suína |
title |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
spellingShingle |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples Santana, Andreza da Costa de Heparin Quality Control High Pressure Liquid Chromatography Health Surveillance Heparina Controle de Qualidade Cromatografia Líquida de Alta Pressão Vigilância Sanitária |
title_short |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
title_full |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
title_fullStr |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
title_full_unstemmed |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
title_sort |
Galactosamine limit analysis in total hexosamines in injectable porcine sodium heparin samples |
author |
Santana, Andreza da Costa de |
author_facet |
Santana, Andreza da Costa de Marinho, Anna Carolina Machado Lima, Patrícia Condé de Leitão, Ozéias de Lima Fonseca, Debora Alves Teixeira, Raíssa Lamin da Conceição, Claudia Maria Jacob, Silvana do Couto |
author_role |
author |
author2 |
Marinho, Anna Carolina Machado Lima, Patrícia Condé de Leitão, Ozéias de Lima Fonseca, Debora Alves Teixeira, Raíssa Lamin da Conceição, Claudia Maria Jacob, Silvana do Couto |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Santana, Andreza da Costa de Marinho, Anna Carolina Machado Lima, Patrícia Condé de Leitão, Ozéias de Lima Fonseca, Debora Alves Teixeira, Raíssa Lamin da Conceição, Claudia Maria Jacob, Silvana do Couto |
dc.subject.por.fl_str_mv |
Heparin Quality Control High Pressure Liquid Chromatography Health Surveillance Heparina Controle de Qualidade Cromatografia Líquida de Alta Pressão Vigilância Sanitária |
topic |
Heparin Quality Control High Pressure Liquid Chromatography Health Surveillance Heparina Controle de Qualidade Cromatografia Líquida de Alta Pressão Vigilância Sanitária |
description |
Introduction: Research, one of the core areas of health surveillance, has its importance justified by its search for answers to various health problems. Heparin, a biological product with anticoagulant and antithrombotic properties, has been related to adverse events between the years 2007–2008. Because of that, the official compendiums updated the monograph for raw material. However, there is a lack of monographs that evaluate the final product. Objective: The goal of this study is to propose a physicochemical method of analysis of the limits of galactosamine in total hexosamine from the finished product of porcine sodium heparin. Method: We developed an analytical method from the ionexchange high performance liquid chromatography with amperometric detection, with the appropriate evaluations of the system suitability for posterior analysis of three samples of porcine sodium heparin previously submitted to the sample preparation protocol through the Micro Bio-Spin column. Results: The samples were compared to the solution of the system suitability and raw material of porcine sodium heparin. We could detect the presence of galactosamine in one of the three analyzed samples in lower amounts than the limit stipulated by the American pharmacopeia. Conclusions: We concluded that the aforementioned method is efficient for the analysis of the finished product and that is the reason why it will be suggested to the Brazilian pharmacopeia. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-05-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed article" "Artículo revisado por pares" "Artigo avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033 10.22239/2317-269X.01033 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033 |
identifier_str_mv |
10.22239/2317-269X.01033 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033/447 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1033/485 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
publisher.none.fl_str_mv |
Instituto Nacional de Controle de Qualidade em Saúde |
dc.source.none.fl_str_mv |
Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 2 (2018): May; 61-66 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 2 (2018): Puede; 61-66 Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 2 (2018): Maio; 61-66 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
collection |
Vigilância Sanitária em Debate |
repository.name.fl_str_mv |
Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br |
_version_ |
1797042045176512512 |