Nitrosaminas em insumos farmacêuticos ativos
Autor(a) principal: | |
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Data de Publicação: | 2024 |
Tipo de documento: | Trabalho de conclusão de curso |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFSCAR |
Texto Completo: | https://repositorio.ufscar.br/handle/ufscar/19336 |
Resumo: | Since 1972, N-nitrosamines have been the subject of study in medication composition. However, in July 2018, the presence of the N-nitrosamine NDMA was identified in Valsartan, leading to the recall of this medication. Subsequently, in August 2018, there were also recalls of Losartan and Irbesartan. Following this milestone, studies on these organic compounds, characterized by the presence of an amine group linked to a nitroso group, have been constantly advancing, prompting regulatory revisions aimed at consumer safety. To prevent medication shortages, guidelines and resolutions have been developed to assist in assessing and controlling risks, considering acceptable limits for daily intake. Consequently, there was a need to understand the pathways of formation of these impurities during the manufacturing process of both pharmaceutics and medications. In this context, this study aimed to evaluate potential formation routes of these impurities and how we can establish their limits, assessing whether there is proper control over nitrosamines. |
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Rossoni, CarolinaCarneiro, Renato Lajarimhttp://lattes.cnpq.br/8065852319463976http://lattes.cnpq.br/0009229316865375https://orcid.org/0000-0002-6857-21902024-02-16T14:08:11Z2024-02-16T14:08:11Z2024-01-17ROSSONI, Carolina. Nitrosaminas em insumos farmacêuticos ativos. 2024. Trabalho de Conclusão de Curso (Graduação em Química) – Universidade Federal de São Carlos, São Carlos, 2024. Disponível em: https://repositorio.ufscar.br/handle/ufscar/19336.https://repositorio.ufscar.br/handle/ufscar/19336Since 1972, N-nitrosamines have been the subject of study in medication composition. However, in July 2018, the presence of the N-nitrosamine NDMA was identified in Valsartan, leading to the recall of this medication. Subsequently, in August 2018, there were also recalls of Losartan and Irbesartan. Following this milestone, studies on these organic compounds, characterized by the presence of an amine group linked to a nitroso group, have been constantly advancing, prompting regulatory revisions aimed at consumer safety. To prevent medication shortages, guidelines and resolutions have been developed to assist in assessing and controlling risks, considering acceptable limits for daily intake. Consequently, there was a need to understand the pathways of formation of these impurities during the manufacturing process of both pharmaceutics and medications. In this context, this study aimed to evaluate potential formation routes of these impurities and how we can establish their limits, assessing whether there is proper control over nitrosamines.Desde 1972, as N-nitrosaminas têm sido alvo de estudo na composição de medicamentos. Contudo, em julho de 2018, a presença da nitrosamina NMDA foi identificada em Valsartanas, o que resultou no recall desse medicamento. Posteriormente, em agosto de 2018, houve também o recall de losartana e irbesartana. A partir desse marco, os estudos a cerca desses compostos orgânicos, que são caracterizados pela presença de um grupo amina ligada a um grupo nitroso, vem avançando constantemente, gerando revisões de órgãos regulatórios, visando a segurança ao consumidor. Com o intuito de evitar a escassez de medicamentos, foram desenvolvidos guias e resoluções para ajudar na avaliação e controle dos riscos, considerando os limites aceitáveis de ingestão diária. Como consequência, houve a necessidade de compreender as rotas de formação dessas impurezas durante o processo de fabricação dos farmoquímicos e dos medicamentos. Nesse sentido, o presente trabalho teve por objetivo avaliar as possíveis rotas de formação dessa impureza e como podemos determinar seus limites e avaliar se há o controle correto das nitrosaminas.Não recebi financiamentoporUniversidade Federal de São CarlosCâmpus São CarlosQuímica - QUFSCarAttribution-NonCommercial-NoDerivs 3.0 Brazilhttp://creativecommons.org/licenses/by-nc-nd/3.0/br/info:eu-repo/semantics/openAccessNitrosaminasInsumo farmacêutico ativoMedicamentosNitrosaminesActive pharmaceutical ingredientMedicinesCIENCIAS EXATAS E DA TERRA::QUIMICA::QUIMICA ANALITICA::SEPARACAONitrosaminas em insumos farmacêuticos ativosNitrosamines in active pharmaceutical ingredientsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/bachelorThesisreponame:Repositório Institucional da UFSCARinstname:Universidade Federal de São Carlos (UFSCAR)instacron:UFSCARCC-LICENSElicense_rdflicense_rdfapplication/rdf+xml; charset=utf-8810https://repositorio.ufscar.br/bitstream/ufscar/19336/2/license_rdff337d95da1fce0a22c77480e5e9a7aecMD52ORIGINALCarolina Rossoni - TCC final.pdfCarolina Rossoni - TCC final.pdfTrabalho de conclusão de cursoapplication/pdf1466051https://repositorio.ufscar.br/bitstream/ufscar/19336/1/Carolina%20Rossoni%20-%20TCC%20final.pdf230ac8fbcf7a870d32c580d0930877c4MD51TEXTCarolina Rossoni - TCC final.pdf.txtCarolina Rossoni - TCC final.pdf.txtExtracted texttext/plain39311https://repositorio.ufscar.br/bitstream/ufscar/19336/3/Carolina%20Rossoni%20-%20TCC%20final.pdf.txtf7b6e6c0d0f0cb8ae503ed89a24034f0MD53ufscar/193362024-05-14 17:33:29.907oai:repositorio.ufscar.br:ufscar/19336Repositório InstitucionalPUBhttps://repositorio.ufscar.br/oai/requestopendoar:43222024-05-14T17:33:29Repositório Institucional da UFSCAR - Universidade Federal de São Carlos (UFSCAR)false |
dc.title.por.fl_str_mv |
Nitrosaminas em insumos farmacêuticos ativos |
dc.title.alternative.eng.fl_str_mv |
Nitrosamines in active pharmaceutical ingredients |
title |
Nitrosaminas em insumos farmacêuticos ativos |
spellingShingle |
Nitrosaminas em insumos farmacêuticos ativos Rossoni, Carolina Nitrosaminas Insumo farmacêutico ativo Medicamentos Nitrosamines Active pharmaceutical ingredient Medicines CIENCIAS EXATAS E DA TERRA::QUIMICA::QUIMICA ANALITICA::SEPARACAO |
title_short |
Nitrosaminas em insumos farmacêuticos ativos |
title_full |
Nitrosaminas em insumos farmacêuticos ativos |
title_fullStr |
Nitrosaminas em insumos farmacêuticos ativos |
title_full_unstemmed |
Nitrosaminas em insumos farmacêuticos ativos |
title_sort |
Nitrosaminas em insumos farmacêuticos ativos |
author |
Rossoni, Carolina |
author_facet |
Rossoni, Carolina |
author_role |
author |
dc.contributor.authorlattes.por.fl_str_mv |
http://lattes.cnpq.br/0009229316865375 |
dc.contributor.advisor1orcid.por.fl_str_mv |
https://orcid.org/0000-0002-6857-2190 |
dc.contributor.author.fl_str_mv |
Rossoni, Carolina |
dc.contributor.advisor1.fl_str_mv |
Carneiro, Renato Lajarim |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/8065852319463976 |
contributor_str_mv |
Carneiro, Renato Lajarim |
dc.subject.por.fl_str_mv |
Nitrosaminas Insumo farmacêutico ativo Medicamentos |
topic |
Nitrosaminas Insumo farmacêutico ativo Medicamentos Nitrosamines Active pharmaceutical ingredient Medicines CIENCIAS EXATAS E DA TERRA::QUIMICA::QUIMICA ANALITICA::SEPARACAO |
dc.subject.eng.fl_str_mv |
Nitrosamines Active pharmaceutical ingredient Medicines |
dc.subject.cnpq.fl_str_mv |
CIENCIAS EXATAS E DA TERRA::QUIMICA::QUIMICA ANALITICA::SEPARACAO |
description |
Since 1972, N-nitrosamines have been the subject of study in medication composition. However, in July 2018, the presence of the N-nitrosamine NDMA was identified in Valsartan, leading to the recall of this medication. Subsequently, in August 2018, there were also recalls of Losartan and Irbesartan. Following this milestone, studies on these organic compounds, characterized by the presence of an amine group linked to a nitroso group, have been constantly advancing, prompting regulatory revisions aimed at consumer safety. To prevent medication shortages, guidelines and resolutions have been developed to assist in assessing and controlling risks, considering acceptable limits for daily intake. Consequently, there was a need to understand the pathways of formation of these impurities during the manufacturing process of both pharmaceutics and medications. In this context, this study aimed to evaluate potential formation routes of these impurities and how we can establish their limits, assessing whether there is proper control over nitrosamines. |
publishDate |
2024 |
dc.date.accessioned.fl_str_mv |
2024-02-16T14:08:11Z |
dc.date.available.fl_str_mv |
2024-02-16T14:08:11Z |
dc.date.issued.fl_str_mv |
2024-01-17 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/bachelorThesis |
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bachelorThesis |
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publishedVersion |
dc.identifier.citation.fl_str_mv |
ROSSONI, Carolina. Nitrosaminas em insumos farmacêuticos ativos. 2024. Trabalho de Conclusão de Curso (Graduação em Química) – Universidade Federal de São Carlos, São Carlos, 2024. Disponível em: https://repositorio.ufscar.br/handle/ufscar/19336. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufscar.br/handle/ufscar/19336 |
identifier_str_mv |
ROSSONI, Carolina. Nitrosaminas em insumos farmacêuticos ativos. 2024. Trabalho de Conclusão de Curso (Graduação em Química) – Universidade Federal de São Carlos, São Carlos, 2024. Disponível em: https://repositorio.ufscar.br/handle/ufscar/19336. |
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https://repositorio.ufscar.br/handle/ufscar/19336 |
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Attribution-NonCommercial-NoDerivs 3.0 Brazil http://creativecommons.org/licenses/by-nc-nd/3.0/br/ info:eu-repo/semantics/openAccess |
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Attribution-NonCommercial-NoDerivs 3.0 Brazil http://creativecommons.org/licenses/by-nc-nd/3.0/br/ |
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openAccess |
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Universidade Federal de São Carlos Câmpus São Carlos Química - Q |
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Universidade Federal de São Carlos Câmpus São Carlos Química - Q |
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