Nitrosamine Impurities in Herbal Formulations: A Review of Risks and Mitigation Strategies

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.

Identification of Synthetic Impurities and Their Significance in Natural Products Quality Control

“…4 In conclusion, the diversity of impurities in natural products diverges substantially from those encountered in synthetic chemicals or analogues, as influenced by factors such as the synthetic pathway, extraction techniques, raw materials, solvents and intermediate products. 4,11 Expanding upon this innovative paradigm, the development of pioneering analytical methodologies such as HPLC, LC-MS/MS, inductively coupled plasma mass spectrometry, high-resolution mass spectrometry and gas chromatography-mass spectrometry for the identification and characterization of impurities in synthetic chemicals or analogues emerges as an efficacious strategy for addressing issues related to natural product adulteration and ensuring quality control. This groundbreaking approach holds considerable promise across diverse domains, encompassing quality control in the analysis of natural drugs, food assessment and the anticipation of potential toxicities.…”