Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer

Detalhes bibliográficos
Autor(a) principal: Costa,Fernanda S. L.
Data de Publicação: 2015
Outros Autores: Pedroza,Ricardo H. P., Porto,Dayanne L., Amorim,Marcelo V. P., Lima,Kássio M. G.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Journal of the Brazilian Chemical Society (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532015000100064
Resumo: One of the keys to maintain high manufacturing quality improvement is the use of control charts. In this work, multivariate control charts based on significant principal component (PC) scores and net analytical signal (NAS) were developed to simultaneously monitor the quality of two active pharmaceutical ingredients (API) (isoniazid and rifampicin) in pharmaceutical formulation (laboratory samples and production samples) using a portable near infrared spectrometer. The limits for both multivariate charts were estimated using the quality specifications from the pharmaceutical formulation (± 5% of the nominal content of each API). The use of these multivariate control charts has provided a simple and powerful tool to evaluate the content of pharmaceutical formulations based on isoniazid and rifampicin capsules combined with near infrared spectroscopy. The procedure is rapid and adjustable for monitoring the production of the pharmaceutical preparations produced at UFRN/Brazil toward the process analytical technology (PAT) for the treatment of pulmonary tuberculosis.
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spelling Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometermultivariate control chartprincipal component analysisnet analyte signalprocess analyte technologynear infrared spectroscopyOne of the keys to maintain high manufacturing quality improvement is the use of control charts. In this work, multivariate control charts based on significant principal component (PC) scores and net analytical signal (NAS) were developed to simultaneously monitor the quality of two active pharmaceutical ingredients (API) (isoniazid and rifampicin) in pharmaceutical formulation (laboratory samples and production samples) using a portable near infrared spectrometer. The limits for both multivariate charts were estimated using the quality specifications from the pharmaceutical formulation (± 5% of the nominal content of each API). The use of these multivariate control charts has provided a simple and powerful tool to evaluate the content of pharmaceutical formulations based on isoniazid and rifampicin capsules combined with near infrared spectroscopy. The procedure is rapid and adjustable for monitoring the production of the pharmaceutical preparations produced at UFRN/Brazil toward the process analytical technology (PAT) for the treatment of pulmonary tuberculosis.Sociedade Brasileira de Química2015-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532015000100064Journal of the Brazilian Chemical Society v.26 n.1 2015reponame:Journal of the Brazilian Chemical Society (Online)instname:Sociedade Brasileira de Química (SBQ)instacron:SBQ10.5935/0103-5053.20140214info:eu-repo/semantics/openAccessCosta,Fernanda S. L.Pedroza,Ricardo H. P.Porto,Dayanne L.Amorim,Marcelo V. P.Lima,Kássio M. G.eng2015-02-03T00:00:00Zoai:scielo:S0103-50532015000100064Revistahttp://jbcs.sbq.org.brONGhttps://old.scielo.br/oai/scielo-oai.php||office@jbcs.sbq.org.br1678-47900103-5053opendoar:2015-02-03T00:00Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)false
dc.title.none.fl_str_mv Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
title Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
spellingShingle Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
Costa,Fernanda S. L.
multivariate control chart
principal component analysis
net analyte signal
process analyte technology
near infrared spectroscopy
title_short Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
title_full Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
title_fullStr Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
title_full_unstemmed Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
title_sort Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
author Costa,Fernanda S. L.
author_facet Costa,Fernanda S. L.
Pedroza,Ricardo H. P.
Porto,Dayanne L.
Amorim,Marcelo V. P.
Lima,Kássio M. G.
author_role author
author2 Pedroza,Ricardo H. P.
Porto,Dayanne L.
Amorim,Marcelo V. P.
Lima,Kássio M. G.
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Costa,Fernanda S. L.
Pedroza,Ricardo H. P.
Porto,Dayanne L.
Amorim,Marcelo V. P.
Lima,Kássio M. G.
dc.subject.por.fl_str_mv multivariate control chart
principal component analysis
net analyte signal
process analyte technology
near infrared spectroscopy
topic multivariate control chart
principal component analysis
net analyte signal
process analyte technology
near infrared spectroscopy
description One of the keys to maintain high manufacturing quality improvement is the use of control charts. In this work, multivariate control charts based on significant principal component (PC) scores and net analytical signal (NAS) were developed to simultaneously monitor the quality of two active pharmaceutical ingredients (API) (isoniazid and rifampicin) in pharmaceutical formulation (laboratory samples and production samples) using a portable near infrared spectrometer. The limits for both multivariate charts were estimated using the quality specifications from the pharmaceutical formulation (± 5% of the nominal content of each API). The use of these multivariate control charts has provided a simple and powerful tool to evaluate the content of pharmaceutical formulations based on isoniazid and rifampicin capsules combined with near infrared spectroscopy. The procedure is rapid and adjustable for monitoring the production of the pharmaceutical preparations produced at UFRN/Brazil toward the process analytical technology (PAT) for the treatment of pulmonary tuberculosis.
publishDate 2015
dc.date.none.fl_str_mv 2015-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.5935/0103-5053.20140214
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
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dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Sociedade Brasileira de Química
publisher.none.fl_str_mv Sociedade Brasileira de Química
dc.source.none.fl_str_mv Journal of the Brazilian Chemical Society v.26 n.1 2015
reponame:Journal of the Brazilian Chemical Society (Online)
instname:Sociedade Brasileira de Química (SBQ)
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instname_str Sociedade Brasileira de Química (SBQ)
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reponame_str Journal of the Brazilian Chemical Society (Online)
collection Journal of the Brazilian Chemical Society (Online)
repository.name.fl_str_mv Journal of the Brazilian Chemical Society (Online) - Sociedade Brasileira de Química (SBQ)
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