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27. N-NITROSAMINES IN PHARMACEUTICALS: A CURRENT PROBLEM, AN OLD REALITY

Author

Aglio,Tharcilla de Castro, Diniz,Vinicíus, Matos,Maria Fernanda Araujo Vieira, Rosa,Paulo Pires Cesar, and Rath,Susanne

Subjects
N-nitrosamines, nitrosating agents, nitrosable amines, pharmaceuticals, DNA reactive impurities
Abstract

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.

Published
2022

30. Determinação de traços de enxofre organico e elementar, atraves de redução a sulfeto pelo niquel de Raney e detecção por voltametria de redissolução catodica

Author

Rath, Susanne, 1962, Aleixo, Luiz Manoel, 1945-2003, Universidade Estadual de Campinas. Instituto de Química, and UNIVERSIDADE ESTADUAL DE CAMPINAS

Subjects
Enxofre, Reações químicas, Voltametria
Abstract

Orientador : Luiz M. Aleixo Dissertação (mestrado) - Universidade Estadual de Campinas, Instituto de Quimica Mestrado

Published
2021

33. Effect of carboxylate compounds on the electrochemical behavior of dopamine at a mercury electrode

Author

Winter Eduardo, Carvalho Rosangela M. de, Kubota Lauro T., and Rath Susanne

Subjects
dopamine, electrochemical behavior, carboxylate compounds, mercury electrode, Chemistry, QD1-999
Abstract

The electrochemical oxidation of dopamine leads to deposition of polymeric films on the surfaces of solid state electrodes, decreasing the electrode activity. With a mercury electrode, the oxidation of dopamine occurs in the potential region of mercury oxidation. However, in the presence of carboxylic compounds the cyclic voltammogram of dopamine is different and presents a new electroactive product resulting from the oxidation of dopamine. This work describes preliminary results for the electrochemical behavior of dopamine at the Hg-electrode in the presence of acetate, citrate and EDTA.

Published
2003

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