Nitrosamine

Abstract Nitrites in pharmaceutical excipients are a known critical factor for the formation of nitrosamine impurities. The origin and variability...

Abstract This work focused on N-nitroso-fluoxetine, a N-nitrosamine drug substance-related impurity (NDSRI) formed in fluoxetine-containing products via nitrosation pathways. N-nitroso-fluoxetine...

Abstract The generation of N-nitrosamine compounds (NOCs) in drugs presents a critical regulatory challenge owing to their potential mutagenicity and exceptionally...

Abstract We developed a headspace gas chromatography method with flame ionization detection (HSGC-FID) for trace nitrite determination in pharmaceutical excipients....

Abstract Nitrosamines were first identified in the 1950s as carcinogenic contaminants in food, tobacco, and industrial chemicals. Among them, N-nitrosodimethylamine...

MEGGLE introduced an interactive, science-based tool designed to help you assess nitrosamine formation risk and optimize acceptable nitrite limits in...

Understanding the Risks Associated with Nitrosamines Nitrosamines have become a major concern in the pharmaceutical industry since their detection in...

Abstract The recovery of solvents in pharmaceutical manufacturing offers substantial sustainability benefits but raises concerns about the potential carryover of...

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...