Multivariate Control Charts for Simultaneous Quality Monitoring of Isoniazid and Rifampicin in a Pharmaceutical Formulation Using a Portable Near Infrared Spectrometer
Autor(a) principal: | |
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Data de Publicação: | 2015 |
Outros Autores: | , , , |
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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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 |
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=S0103-50532015000100064 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532015000100064 |
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 |
eu_rights_str_mv |
openAccess |
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) instacron:SBQ |
instname_str |
Sociedade Brasileira de Química (SBQ) |
instacron_str |
SBQ |
institution |
SBQ |
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) |
repository.mail.fl_str_mv |
||office@jbcs.sbq.org.br |
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1750318176641482752 |