International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines

Recalls of some batches of metformin have occurred due to the detection of N -nitrosodimethylamine (NDMA) in amounts above the acceptable intake (AI) of 96 ng per day. Prior to the recalls, an international regulatory laboratory network had been monitoring drugs for nitrosamine impurities with each...

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Bibliographic Details
Published in:	The AAPS journal Vol. 24; no. 3; p. 56
Main Authors:	Keire, David A., Bream, Robert, Wollein, Uwe, Schmaler-Ripcke, Jeannette, Burchardt, Annette, Conti, Massimiliano, Zmysłowski, Adam, Keizers, Peter, Morin, Justin, Poh, Jalene, George, Mark, Wierer, Michael
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 21.04.2022 Springer
Subjects:	Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Diabetes therapy Dimethylnitrosamine - analysis Humans Independent regulatory commissions Metformin Metformin - analysis Nitrosamines - analysis Nitrosoamines Pharmacology/Toxicology Pharmacy Research Article Type 2 diabetes Valsartan metformin drug supply nitrosamines NDMA International regulatory laboratories
ISSN:	1550-7416, 1550-7416
Online Access:	Get full text
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