Abstract
Nitrosamines are a class of chemical compounds that have been found to be
impurities in a variety of pharmaceutical products. These impurities have raised
concerns due to their potential carcinogenic effects. Recent studies have
identified nitrosamines as impurities in a number of pharmaceutical products
including angiotensin II receptor blockers (ARBs) and proton pump inhibitors
(PPIs). The presence of nitrosamines in these products has led to recalls and
market withdrawals. In addition to pharmaceuticals, nitrosamines have also been
found in some herbal medicines particularly those containing traditional Chinese
medicinal ingredients. The presence of nitrosamines in herbal formulations poses
a significant risk to public health and highlights the need for quality control
and regulations in the herbal drug industry. The present review article aims to
discuss nitrosamine impurities (NMI) prominent causes, risks and scientific
strategies for preventing NMI in herbal formulations. The primary objective of
this study is to examine the origins of nitrosamine contamination in herbal
formulations, the risks associated with these contaminants, and the methods for
reducing them. The significance of thorough testing and examination before
releasing herbal products to the public is also emphasized. In conclusion, the
presence of nitrosamines is not limited to pharmaceutical products and poses a
significant threat to the safety of herbal drugs as well. Adequate testing and
extensive research are crucial for producing and distributing herbal medicines
to the general population.
Key words
carcinogenicity - herbal formulations - nitrosamine impurities - quality control -
synthetic phyto active constituents
