The EU Response to the Presence of Nitrosamine Impurities in Medicines.
carcinogenicity
human medicines
linear extrapolation
metformin
nitrite (NaNO2)
nitrosamines
ranitidine
sartans
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2021
2021
Historique:
received:
24
09
2021
accepted:
12
10
2021
entrez:
6
12
2021
pubmed:
7
12
2021
medline:
7
12
2021
Statut:
epublish
Résumé
The unexpected detection of nitrosamine impurities in human medicines has recently seen global regulators act to understand the risks of these contaminations to patients and to limit their presence. Over 300 nitrosamines are known, many of which are highly potent mutagenic carcinogens. Regulators first became aware of the presence of nitrosamines in EU medicines in 2018, with reports of detection of
Identifiants
pubmed: 34869504
doi: 10.3389/fmed.2021.782536
pmc: PMC8641785
doi:
Types de publication
Journal Article
Langues
eng
Pagination
782536Informations de copyright
Copyright © 2021 Ruepp, Frötschl, Bream, Filancia, Girard, Spinei, Weise and Whomsley.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
Molecules. 2020 Nov 13;25(22):
pubmed: 33202951