Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic reviewOA
Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review
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.
Hemanth P.R.Vikram;Ravandur S.Chandan;Pramod Kumar;Bannimath Gurupadayya;Tegginamath Pramod Kumar;Gunjan Kumar;Narasimha M.Beeraka;Rajashree Deka;Sheik Mohammed Suhail;Sandeep Jat;Namitha Bannimath;Gayatiri Padmanabhan
Department of Pharmaceutical Chemistry,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,India||Xenone Healthcare Pvt.Ltd.,New Delhi,110076,IndiaDepartment of Pharmaceutical Chemistry,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,IndiaDepartment of Pharmaceutical Analysis,National Institute of Pharmaceutical Education and Research(NIPER)-Guwahati,Changsari,781101,IndiaDepartment of Pharmaceutics,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,IndiaXenone Healthcare Pvt.Ltd.,New Delhi,110076,IndiaDepartment of Human Anatomy,I.M.Sechenov First Moscow State Medical University(Sechenov University),Moscow,119991,Russian Federation||Department of Pharmacology,Raghavendra Institute of Pharmaceutical Education and Research(RIPER),Ananthapuramu,515721,India||Herman B.Wells Center for Pediatric Research,Department of Pediatrics,Indiana University School of Medicine,Indianapolis,IN,46202,USAAnimal Physiology and Biochemistry Laboratory,Department of Zoology,Gauhati University,Guwahati,781014,IndiaDepartment of Pharmacology,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,IndiaDepartment of Pharmacology,University of Galway,Galway,H91 TK33,Ireland
CarcinogenicityGenotoxicityMutagenicityMolecular toxicityNitrosamine impuritiesNitrosamine drug substance-related impurities
《药物分析学报（英文）》 2024 (005)
639-652 / 14
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