Authors
Khorolskiy M. D.
Senior Laboratory Assistant, A.P. Arzamascev Chair for Pharmaceutical and Toxicological Chemistry1
Chaplenko A. A.
Expert, Biomedical Clinical Products Laboratory2
Vlasov A. M.
PhD, CPhyS, Assistant Professor, A.P. Arzamascev Chair for Pharmaceutical and Toxicological Chemistry1
Maslennikova N. V.
PhD, CPhyS, Head, Pharmacopoeia Laboratory2
Ramenskaya G. V.
Doctor of Physics, Director, Institute of Pharmacy1
1 - I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation
2 - Scientific Center for Expert Evaluation of Medicinal Products, Moscow, Russian Federation
Corresponding Author
Khorolskiy Mikhail; e-mail: mkhorolski@gmail.com
Conflict of interest
None declared.
Funding
The study had no sponsorship.
Abstract
In the review, the main sources of the nitrosamines formation in drugs were established, as well as the main mechanism of the toxic effect of this impurities group on the human body. The reason of the increased nitrosamines content in the group of sartan drugs is the use of nitrous acid in the manufacturing process. Nitrous acid interacts with common organic solvents, that contain an amino group, forming toxic compounds. Moreover, impurities of nitrosamines can be formed during the degradation of the principal or auxiliary substances. The results of the review are conclusions about the necessity of further studies of the formation pathways and the toxicity mechanism, besides the development of methods for their determination in pharmaceutical substances and drugs.
Key words
genotoxic impurities, nitrosamines, valsartan
DOI
References
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