Nitrosamine

Abstract This work presents a method optimization strategy for determining nitrite ions in pharmaceutical excipients. After derivatization, nitrite ions were...

Abstract Rigorous control of N-nitrosamine impurities within drug products is essential due to their potential carcinogenicity. Nitrosamines are often formed through...

Abstract Between 2018 and 2021, losartan was the most often recalled product (24% of total recalls) followed by metformin tablets...

Join our inspiring expert talk on nitrites/nitrosamines:  Description: Since 2018, nitrosamines have gone from an unexpected impurity issue to a...

Abstract Following the discovery of N-nitrosamines in a range of medicinal products, regulatory agencies have required marketing authorization holders to undertake...

Frankfurt, Germany, 02 October, 2024 The future of excipients is here: Meet DFE Pharma at CPHI DFE Pharma invites you to...

Abstract The presence of N-nitrosamine impurities and nitrosamine drug substance-related impurities (NDSRIs) in medicines poses a significant challenge not only for...

Abstract To prevent contamination by nitrosamine drug substance-related impurities (NDSRIs) in solid dosage forms, the modeling of drug nitrosation reactions...

See this article by Vikram Thermo: A Sudden Jolt: When the Medicine Became the Risk In July 2018, the pharmaceutical...

Abstract Nitrosamine impurities have provoked numerous global medicine recalls due to their possible presence during drug manufacturing or storage. Regarding...