NDMA analytics in metformin products: Comparison of methods and pitfalls
Matthias Fritzsche(Merck KGaA, Darmstadt (Germany)), Joerg Schlingemann(Merck KGaA, Darmstadt (Germany)), Judith Keitel(Merck KGaA, Darmstadt (Germany)), Christoph Saal(Merck KGaA, Darmstadt (Germany)), Mark Harrison(AstraZeneca (United Kingdom)), Anja Goettsche(Merck KGaA, Darmstadt (Germany)), Maic Seegel(Merck KGaA, Darmstadt (Germany)), Philipp Reifenberg(Merck KGaA, Darmstadt (Germany)), Phillip Krueger(Merck KGaA, Darmstadt (Germany)), Elodie Barrau(European Organisation for Rare Diseases), Stefan Leicht(Merck KGaA, Darmstadt (Germany)), Romane Baranowski(European Organisation for Rare Diseases), Brunhilde Guessregen(Merck KGaA, Darmstadt (Germany)), Tony Bristow(AstraZeneca (United Kingdom)), Nicholas O'Neill(AstraZeneca (United Kingdom)), Alexandra Cimelli(European Organisation for Rare Diseases), Emmanuel Desmartin(European Organisation for Rare Diseases), Sebastian Hickert(Merck KGaA, Darmstadt (Germany)), Annette Kirsch(Merck KGaA, Darmstadt (Germany)), Giorgio Blom(AstraZeneca (United Kingdom)), Bruno Mouton(Merck KGaA, Darmstadt (Germany))
Cited by 47
Related Papers
The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny
|Organic Process Research & Development|2023|82
Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite
|International Journal of Pharmaceutics|2022|68
Control of N-nitrosamine impurities in drug products: Progressing the current CPCA framework and supporting the derivation of robust compound specific acceptable intakes
|Regulatory Toxicology and Pharmacology|2024|13