Nitrosamine

Abstract Atmospheric nitrogen oxides (NOx) have emerged as a potential contributor to nitrosamine formation in active pharmaceutical ingredients (APIs) containing...

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...