Modern methods for controlling and regulating impurities in pharmaceuticals

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Abstract

Introduction. The article is dedicated to modern principles of regulation and control of impurities in pharmaceutical products and active pharmaceutical substances, which is a crucial task for the pharmaceutical industry. The relevance of this research stems from the fact that the presence of impurities in pharmaceutical products can significantly affect their safety and efficacy, making the development of stringent control methods throughout the entire life cycle of a pharmaceutical product essential. Even small amounts of impurities can cause adverse effects or reduce the therapeutic value of drugs, as evidenced by historical examples.

The aim of the study is to analyze and systematize contemporary approaches to the detection and regulation of impurities in pharmaceutical products. The paper reviews current regulatory requirements, including guidelines from the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and regulatory documents of the Eurasian Economic Community, as well as national pharmacopeias of the Russian Federation, the United States of America, and the European Union.

Conclusion. Additionally, the article emphasizes the need for harmonization of standards and practices for impurity control, which is especially relevant in the context of the globalization of the pharmaceutical market. Harmonization not only enhances the safety and efficacy of pharmaceutical products but also improves patients' quality of life by reducing the risk of adverse effects associated with impurities. The article also explores prospects for further improvement of regulatory acts and the implementation of advanced technologies aimed at enhancing standardization and quality control in the pharmaceutical industry.

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About the authors

Nikolay A. Shulga

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Author for correspondence.
Email: shu.nik344@gmail.com
ORCID iD: 0000-0001-8717-6161

Postgraduate Student of the Department of Pharmaceutical and Toxicological Chemistry named after A.P. Arzamastsev of the Institute of Pharmacy named after A.P. Nelyubin

Russian Federation, Moscow

Anastasia G. Merkushova

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Email: anastasya@myrambler.ru
ORCID iD: 0009-0009-6791-2200

Student

Russian Federation, Moscow

Vladimir I. Gegechkori

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Email: gegechkori_v_i@staff.sechenov.ru
ORCID iD: 0000-0001-8437-1148

Candidate of Pharmaceutical Sciences, Associate Professor of the Department of Pharmaceutical and Toxicological Chemistry named after A.P. Arzamastsev of the Institute of Pharmacy named after A.P. Nelyubin

Russian Federation, Moscow

Dmitry V. Chugaev

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Email: chugaev_d_v@staff.sechenov.ru
ORCID iD: 0000-0001-5127-5088

Candidate of Pharmaceutical Sciences, Associate Professor of the Department of Pharmaceutical and Toxicological Chemistry named after A.P. Arzamastsev of the Institute of Pharmacy named after A.P. Nelyubin

Russian Federation, Moscow

Galina V. Ramenskaya

I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Email: ramenskaya_g_v@staff.sechenov.ru
ORCID iD: 0000-0001-8779-3573

Doctor of Pharmaceutical Sciences, Professor, Director of the Institute of Pharmacy named after A.P. Nelyubin

Russian Federation, Moscow

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