Nitrosamines crisis in pharmaceuticals-Insights on toxicological implications,root causes and risk assessment:A systematic review
10.1016/j.jpha.2023.12.009
- Author:
P.R.Vikram HEMANTH
1
,
2
;
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
Author Information
1. Department of Pharmaceutical Chemistry,JSS College of Pharmacy Mysuru,JSS Academy of Higher Education and Research(JSSAHER),Mysuru,570015,India
2. Xenone Healthcare Pvt.Ltd.,New Delhi,110076,India
- Keywords:
Carcinogenicity;
Genotoxicity;
Mutagenicity;
Molecular toxicity;
Nitrosamine impurities;
Nitrosamine drug substance-related impurities
- From:
Journal of Pharmaceutical Analysis
2024;14(5):639-652
- CountryChina
- Language:Chinese
-
Abstract:
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.
