1.Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review
P.R.Vikram HEMANTH ; Kumar Pramod TEGGINAMATH ; Kumar GUNJAN ; M.Beeraka NARASIMHA ; Deka RAJASHREE ; Suhail Mohammed SHEIK ; Jat SANDEEP ; Bannimath NAMITHA ; Padmanabhan GAYATIRI ; S.Chandan RAVANDUR ; Kumar PRAMOD ; Gurupadayya BANNIMATH
Journal of Pharmaceutical Analysis 2024;14(5):639-652
The presence of N-nitroso compounds,particularly N-nitrosamines,in pharmaceutical products has raised global safety concems due to their significant genotoxic and mutagenic effects.This systematic review investigates their toxicity in active pharmaceutical ingredients(APIs),drug products,and phar-maceutical excipients,along with novel analytical strategies for detection,root cause analysis,refor-mulation strategies,and regulatory guidelines for nitrosamines.This review emphasizes the molecular toxicity of N-nitroso compounds,focusing on genotoxic,mutagenic,carcinogenic,and other physiological effects.Additionally,it addresses the ongoing nitrosamine crisis,the development of nitrosamine-free products,and the importance of sensitive detection methods and precise risk evaluation.This compre-hensive overview will aid molecular biologists,analytical scientists,formulation scientists in research and development sector,and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.
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