Abstract
The toxicological risk assessment (TRA) of elemental impurities (EI) in especially herbal medicinal products (HMP) is a significant challenge for pharmaceutical industry. In Europe, very popular are traditional HMP with valerian root (Valeriana officinalis L., radix) for relief of mild symptoms of mental stress and to aid sleep. The aim of our unique article is the comprehensive TRA of Cu, Mn, and Zn as EI in HMP with V. officinalis L., radix available in Polish pharmacies. This article is a continuation of our previously conducted studies about TRA of heavy metals (Pb and Cd) in these same samples. Investigated elements were determined by flame atomic absorption spectrometry (F AAS). The values of the correlation coefficients (R > 0.998) confirm the linearity of the applied instrument for precision and accuracy of results. The recoveries, LOD and LOQ values were acceptable. Our results show that all investigated HMP with valerian root available in Polish pharmacies contain Cu (0.16–0.23 mg/L), Mn (0.11–0.76 mg/L), and Zn (0.22–0.48 mg/L) at a very low level. Based on our estimation of EI including single dose (µg/20 mL) and estimated daily intake (µg/day), our results confirm the safety of all pharmaceuticals. To the best of our knowledge, the Cu, Mn, and Zn impurity profile in HMP with V. officinalis L., radix is described for the first time. The applied methodology and results are extremely important from regulatory toxicology point of view (ICH Q3D elemental impurities guideline for pharmaceuticals).
Highlights
The toxicological safety assessment of elemental impuri‐ ties (EI) in plants and herbs as raw materials applied in the pharmaceutical industry is a very important task, but it is a unique topic of scientific articles
Considering the fact that EI do not provide any therapeutic benefit to the patient, their contents in the final pharmaceutical/drug products are extremely important from a toxicological point of view and should be controlled within acceptable limits [1]
The step is evaluation of obtained results with acceptable limits. In this step the measured levels of EI in analyzed product are compared with permitted daily exposure (PDE) values for each ele‐ ment
Summary
The toxicological safety assessment of elemental impuri‐ ties (EI) in plants and herbs as raw materials applied in the pharmaceutical industry is a very important task, but it is a unique topic of scientific articles. Considering the fact that EI do not provide any therapeutic benefit to the patient, their contents in the final pharmaceutical/drug products are extremely important from a toxicological point of view and should be controlled within acceptable limits [1]. There exist potential sources of EI [2, 4] like impurities through interactions with processing equipment or container/closure systems and ingredients of the pharmaceutical/drug product. The step is evaluation of obtained results with acceptable limits. In this step the measured levels of EI in analyzed product are compared with permitted daily exposure (PDE) values for each ele‐ ment (based on ICH Q3D guideline [1, 2]). The last step is summary of toxicological risk assessment (TRA) based on earlier conducted evaluation process
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
