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Safety Assessment of the Trace Element Impurities Ni and Cr in Pharmaceutical Herbal Products for Teething from Polish Pharmacies

  • Kamil JurowskiEmail author
  • Mirosław Krośniak
  • Maria Fołta
  • Barbara Tatar
  • Michael Cole
  • Wojciech Piekoszewski
Article
  • 29 Downloads

Abstract

Control of elemental impurities (EIs) in pharmaceutical herbal products is currently important but not a very popular topic in modern toxicological analysis. The occurrence and concentration of EIs in the pharmaceutical herbal products should be controlled and meet the standards of directive International Conference on Harmonisation’s Q3D Guideline on Elemental Impurities. An interesting area of interest is measuring EIs including toxic and allergic metals in pharmaceutical herbal products for teething. The aim of this article was determination of Ni and Cr impurities in pharmaceutical herbal products for teething available in Polish pharmacies. Justifications were (1) herbs as an important source of EIs and (2) infants may be particularly sensitive to the toxic effects of metals because they tend to absorb a higher fraction of an oral dose. The analysis was carried out using microwave-assisted wet digestion with concentrated nitric acid and electrothermal atomisation atomic absorption spectrometry. The safety assessment involved a triple approach: (1) level of Ni and Cr impurities in pharmaceutical samples; (2) level of Ni and Cr impurities including one-time administration of teething gels and (3) daily intake of metals. In all three cases, the results indicate that the standards of directive ICH Q3D are met for Ni and Cr. Overall, it can be concluded that none of the teething gels represents a health hazard to infants.

Keywords

Elemental impurities Safety assessment Nickel Chromium Teething gels Infants 

Abbreviations

AAS

Atomic absorption spectrometry technique

CRM

Certified reference material

ET AAS

Electrothermal atomisation atomic absorption spectrometry

EIs

Elemental impurities

IARC

International Agency for Research on Cancer;

ICH Q3D

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

PDE

Permitted daily exposure

SD

Standard deviation

US EPA

The United States Environmental Protection Agency

WHO

World Health Organisation

Notes

Compliance with Ethical Standards

This article does not contain any studies with human participants or animals performed by any of the authors.

Conflict of Interest

The authors declare that they have no conflict of interest

Supplementary material

12011_2019_1643_MOESM1_ESM.docx (21 kb)
Supplementary Material 1 (DOCX 21 kb)
12011_2019_1643_MOESM2_ESM.docx (22 kb)
Supplementary Material 2 (DOCX 22 kb)
12011_2019_1643_MOESM3_ESM.docx (28 kb)
Supplementary Material 3 (DOCX 28 kb)

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Faculty of Health PromotionKraków Higher School of Health PromotionKrakówPoland
  2. 2.Department of Food Chemistry and Nutrition, Medical CollegeJagiellonian UniversityKrakówPoland
  3. 3.Faculty of Science and TechnologyAnglia Ruskin UniversityCambridgeUK
  4. 4.Department of Analytical Chemistry, Faculty of ChemistryJagiellonian University in KrakówKrakówPoland
  5. 5.School of BiomedicineFar Eastern Federal UniversityVladivostokRussia

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