Determination of genotoxic impurities in pharmaceutical substances

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DOI: https://doi.org/10.29296/25419218-2020-07-02
Issue: 
7
Year: 
2020

O.V. Ananyina(1), M.D. Khorolsky(1, 2), G.V. Ramenskaya(1, 2), E.A. Zhukov(1), N.V. Maslennikova(1) (1)Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation; (2)I.M. Sechenov First Moscow State Medical University (Sechenov University), 8, Trubetskaya St., Build. 2, Moscow 119991, Russian Federation

The paper considers the approaches applied to determine impurities having potential genotoxicity in the pharmaceutical substances. This type of impurities is able to disrupt the structure of DNA, regardless of their concentration entering the body, as well as to tend to accumulate in tissues and organs. In view of the fact that the cases of detecting genotoxic impurities in pharmaceutical substances have become frequent, the literature sources describing the determination of the impurities in various matrices have been studied. The results of the investigation could divide the genotoxic impurities into two groups, based on their origin. The most commonly used methods for their identification have been defined for each group. Trends in the determination of genotoxic impurities as an aspect of quality control have been formulated.
Keywords: 
genotoxic impurities
purity
N-nitroso derivatives
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