Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review

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外文摘要：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.

外文关键词：

CarcinogenicityGenotoxicityMutagenicityMolecular toxicityNitrosamine impuritiesNitrosamine drug substance-related impurities

作者：

Hemanth P.R.Vikram、Tegginamath Pramod Kumar、Gunjan Kumar、Narasimha M.Beeraka、Rajashree Deka、Sheik Mohammed Suhail、Sandeep Jat、Namitha Bannimath、Gayatiri Padmanabhan、Ravandur S.Chandan、Pramod Kumar、Bannimath Gurupadayya

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作者单位：

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,India

Department of Pharmaceutics,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,India

Department 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,USA

Animal Physiology and Biochemistry Laboratory,Department of Zoology,Gauhati University,Guwahati,781014,India

Department of Pharmacology,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,India

Department of Pharmaceutical Analysis,National Institute of Pharmaceutical Education and Research(NIPER)-Guwahati,Changsari,781101,India

Department of Pharmacology,University of Galway,Galway,H91 TK33,Ireland

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出版年：

2024

DOI：

10.1016/j.jpha.2023.12.009

药物分析学报(英文)

西安交通大学

药物分析学报(英文)

影响因子：0.244

ISSN：2095-1779

年,卷(期)：2024.14(5)