The toxicological analysis of lead impurities in traditional herbal medicinal product with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) from pharmacies in Poland: the impurity profile and comprehensive toxicological risk assessment

Abstract

Traditional herbal medicinal products (THMP) with Thymi herba (Thymus vulgaris L. and Thymus zygis L.) are very popular among the European population. The idea of our study was the toxicological analysis of lead impurities in THMP with Thymi herba obtained from Polish pharmacies. For this purpose, we prepared the impurity profiles and comprehensive toxicological risk assessment. The Pb impurity profiles show lead impurities in all samples investigated (in the range: 2.15–6.99 μg/L). The estimations of Pb impurities in the single dose (32.25–105.01 ng/single dose) and in the daily dose (64.50–210.00 ng/day) were based on the posology recommended by the manufacturers. All the results obtained meet the standards of the ICH Q3D (R1) guideline on elemental impurities according to the levels of Pb. It can be concluded that all investigated THMPs with Thymi herba available in Poland should not represent any health risk to adults.

Graphical Abstract

Keywords:

• Thymi herba
• Thymus vulgaris L
• Thymus zygis L
• Lead
• Toxicological Risk Assessment
• Traditional Herbal Medicinal Products

Acknowledgements

The authors wish to express their gratitude to BT (Department of Food Chemistry and Nutrition, Medical College, Jagiellonian University, Kraków, Poland) for excellent technical assistance.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

No external funding.