CEPHALOSPORINS: PHARMACOPEIA ANALYSIS IN THE CONTEXT OF HARMONIZATION OF THE REQUIREMENTS FOR THE QUALITY OF MEDICINES
Harmonization of requirements for standardization and quality control of medicines, including antibiotics, is one of the necessary conditions for the creation of effective and safe dosage forms, which is noted, in particular, in the decision of the Board of the Eurasian economic Commission №199 “on the concept of harmonization of Pharmacopoeia of the member States of the Eurasian economic Union” from 22.09.15. In modern conditions, characterized by the strengthening of the process of antibiotic resistance and the need to search for new classes and generations of antibiotics, there is a need to analyze the global pharmaceutical experience, which allows to optimize the activities to ensure the unity of requirements for the effectiveness and quality of antibiotics. The paper presents a comparative analysis of the data of national Pharmacopoeia (Russia, USA, Japan, UK, Belarus, Ukraine, International and European) on Pharmacopoeia methods of authentication, quantification, antimicrobial activity of cephalosporin preparations. It is established that national Pharmacopoeia differ both in the breadth of coverage of cephalosporin preparations, and in the methods of establishing their authenticity, antimicrobial activity and quantitative determination. In this regard, it is necessary to intensify the processes of development and implementation of unified methods of Pharmacopoeia analysis of cephalosporin drugs, taking into account the harmonization of requirements with the leading national Pharmacopoeia.