Genotoxic impurities in pharmaceutical products – regulatory, toxicological and pharmaceutical considerations

Katarzyna Regulska; Marcin Michalak; Marek Murias; Beata Stanisz

doi:10.20883/medical.e502

Authors

Katarzyna Regulska Greater Poland Cancer Center https://orcid.org/0000-0002-9584-3128
Marcin Michalak Greater Poland Cancer Center https://orcid.org/0000-0001-5583-0368
Marek Murias Poznan University of Medical Sciences, Departament of Toxicology https://orcid.org/0000-0002-2903-4912
Beata Stanisz Poznan University of Medical Sciences, Departament of Pharmaceutical Chemistry https://orcid.org/0000-0003-4611-7039

DOI:

https://doi.org/10.20883/medical.e502

Keywords:

genotoxicity, impurities, legislation

Abstract

This article provides an overview of the most important aspects around the detecting and reporting of genotoxic impurities in the pharmaceutical industry. It focuses on relevant regulatory, toxicological, and pharmaceutical considerations. In this regard, the concept of Threshold of Toxicological Concern is explained and the most common genotoxic impurities are described. Furthermore, toxicological methods for genotoxic impurities screening are presented. Finally, the article emphasises several issues regarding further development.

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References

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