N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA

N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA

The presence of N-nitrosamines - potentially carcinogenic compounds - is being reported for more than 50 years in pharmaceutical products. However, it only gained notorious prominence in 2018, when regulatory agencies became aware of the presence of N-nitrosodimethylamine in angiotensin II receptor antagonists, drugs that are known as sartans. It did not take long for N-nitrosamine impurities to be identified in other medicines, alerting government agencies and pharmaceutical industries to evaluate and control these impurities in their products to mitigate the risk. The sources of contamination can be numerous, including the use of contaminated raw material, formation in the synthesis of active pharmaceutical ingredients or during storage, the water used in the process, and the packaging material. This review article presents the timeline of the presence of N-nitrosamines in consuming products, toxicological aspects, legislation, and analytical methods. It provides relevant information on possible sources of contamination in the production and storage process that may explain the presence of these compounds considered a cohort of concern in pharmaceuticals.

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Main Authors: Aglio,Tharcilla de Castro, Diniz,Vinicíus, Matos,Maria Fernanda Araujo Vieira, Rosa,Paulo Pires Cesar, Rath,Susanne
Format: Digital revista
Language:Portuguese
Published: Sociedade Brasileira de Química 2022
Online Access:http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422022000800959
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spelling oai:scielo:S0100-404220220008009592022-10-24N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGAAglio,Tharcilla de CastroDiniz,VinicíusMatos,Maria Fernanda Araujo VieiraRosa,Paulo Pires CesarRath,Susanne N-nitrosamines pharmaceuticals nitrosating agents nitrosable amines DNA reactive impurities. The presence of N-nitrosamines - potentially carcinogenic compounds - is being reported for more than 50 years in pharmaceutical products. However, it only gained notorious prominence in 2018, when regulatory agencies became aware of the presence of N-nitrosodimethylamine in angiotensin II receptor antagonists, drugs that are known as sartans. It did not take long for N-nitrosamine impurities to be identified in other medicines, alerting government agencies and pharmaceutical industries to evaluate and control these impurities in their products to mitigate the risk. The sources of contamination can be numerous, including the use of contaminated raw material, formation in the synthesis of active pharmaceutical ingredients or during storage, the water used in the process, and the packaging material. This review article presents the timeline of the presence of N-nitrosamines in consuming products, toxicological aspects, legislation, and analytical methods. It provides relevant information on possible sources of contamination in the production and storage process that may explain the presence of these compounds considered a cohort of concern in pharmaceuticals.info:eu-repo/semantics/openAccessSociedade Brasileira de QuímicaQuímica Nova v.45 n.8 20222022-08-01info:eu-repo/semantics/articletext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422022000800959pt10.21577/0100-4042.20170894
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country Brasil
countrycode BR
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region America del Sur
libraryname SciELO
language Portuguese
format Digital
author Aglio,Tharcilla de Castro
Diniz,Vinicíus
Matos,Maria Fernanda Araujo Vieira
Rosa,Paulo Pires Cesar
Rath,Susanne
spellingShingle Aglio,Tharcilla de Castro
Diniz,Vinicíus
Matos,Maria Fernanda Araujo Vieira
Rosa,Paulo Pires Cesar
Rath,Susanne
N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
author_facet Aglio,Tharcilla de Castro
Diniz,Vinicíus
Matos,Maria Fernanda Araujo Vieira
Rosa,Paulo Pires Cesar
Rath,Susanne
author_sort Aglio,Tharcilla de Castro
title N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
title_short N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
title_full N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
title_fullStr N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
title_full_unstemmed N-NITROSAMINAS EM MEDICAMENTOS: UM PROBLEMA ATUAL, UMA REALIDADE ANTIGA
title_sort n-nitrosaminas em medicamentos: um problema atual, uma realidade antiga
description The presence of N-nitrosamines - potentially carcinogenic compounds - is being reported for more than 50 years in pharmaceutical products. However, it only gained notorious prominence in 2018, when regulatory agencies became aware of the presence of N-nitrosodimethylamine in angiotensin II receptor antagonists, drugs that are known as sartans. It did not take long for N-nitrosamine impurities to be identified in other medicines, alerting government agencies and pharmaceutical industries to evaluate and control these impurities in their products to mitigate the risk. The sources of contamination can be numerous, including the use of contaminated raw material, formation in the synthesis of active pharmaceutical ingredients or during storage, the water used in the process, and the packaging material. This review article presents the timeline of the presence of N-nitrosamines in consuming products, toxicological aspects, legislation, and analytical methods. It provides relevant information on possible sources of contamination in the production and storage process that may explain the presence of these compounds considered a cohort of concern in pharmaceuticals.
publisher Sociedade Brasileira de Química
publishDate 2022
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422022000800959
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AT matosmariafernandaaraujovieira nnitrosaminasemmedicamentosumproblemaatualumarealidadeantiga
AT rosapaulopirescesar nnitrosaminasemmedicamentosumproblemaatualumarealidadeantiga
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