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MerkenNitrosamines
Rubrik: Wissenschaft
(Treffer aus pharmind, Nr. 03, Seite 399 (2020))
Nitrosamines / From Valsartan to Metformin – notorious impurities in drug products · Ganter W, Lehmann B · HWI pharma services GmbH, Rülzheim
Nitrosamines (or more precisely N-nitrosamines) refer to the chemical structure of a nitroso group bonded to a secondary amine (structural formula refer to Fig. 1 ). In June 2018, the EU authorities were notified of a previously undetected impurity, N-nitrosodimethylamine (NDMA), in the active pharmaceutical ingredient (API) valsartan, an angiotensin-II-receptor blocker [ 1 ]. This analytical finding was the start of a series of nitrosamine findings in medicinal products and has developed to a global drug quality issue with continuously growing impact on the manufacturing processes of API and medicinal products. On 5 July 2018, the European Commission (EC) started a ...
