Nitrosamine Impurities in Pharmaceuticals: Regulatory Landscape and Challengesdoi:10.29090/psa.2024.03.24.1854MANUFACTURING processesNITROSOAMINESRAW materialsRISK assessmentDRUGSNitrosamines have drawn considerable attention due to their recognized health risks, notably their association with carcinog...
This article explores the significance of the FDA’s latest recommendations, explaining the nature of nitrosamine impurities, their root causes, and recommended strategies for mitigating their presence in pharmaceuticals. We also will discuss the implications of these recommendations for the glo...
The interaction between secondary/tertiary amines and nitrites or oxides of nitrogen results in the formation of nitrosamines. These precursors of nitrosamines can be found in many products and materials, including frequently used solvents, reagents, pharmaceuticals, OTC products, foodstuffs, tobacco, cosm...
ICH, M7 (R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk, Step 4 version (31 March 2017). EMA, EMA/526934/2019, Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines (Amsterdam, 23 June 2020). EMA...
N-Nitrosamine in Pharmaceuticals Waters - Your Analytical Sidekick in Supporting Risk Assessment, Confirmation and Control of N-nitrosamines in Pharmaceuticals. Ensuring strict control measures are essential to meet regulatory guidelines related to the potential presence of mutagenic impurities in medicines, ...
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Addressing Nitrosamine Analysis Challenges in Pharmaceuticals with the ATNARequest information Detecting nitrosamines in pharmaceutical products is essential for maintaining safety and ensuring regulatory compliance. Following high-profile recalls involving nitrosamine ...
nitrosamine impurities Robust, high throughput routine analysis Single compliance-ready software The use of some common solvents, such as DMF, in the manufacturing process can lead to false-positive results if the interfering compounds cannot be sufficiently se...
The U.S. Food and Drug Administration has been very instrumental in regulating the safety of pharmaceuticals, and its recent guidance towards controlling the impurities of nitrosamine in drugs further strengthens the commitment of this agency. Potentially carcinogenic compounds like nitrosamines may emerge...
ICH Guideline M7(R1) on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (2017) Google Scholar Johnson et al., 2021 G.E. Johnson, et al. Permitted daily exposure limits for noteworthy N-nitrosamines Environ. Mol. Mutagen., 62...