Standardization and quality control of medicinal products is the major purpose of pharmacopoeial analysis. The Russian State Pharmacopoeia celebrated 250 years in 2015 and its background is inexorably associated with the solution to the mentioned problem. The implementation of the XIII edition of the State Pharmacopoeia is an important step to guarantee the quality of medicinal products on the Russian pharmaceutical market and their compliance with international standards, since leading national scientists and experts actively participated in the development of its general monographs and individual monographs.

The article describes the history of the European Pharmacopoeia, which is a unique source of pharmacopoeial drug quality standards, not only for the European part of the continent, but for the entire pharmaceutical world. The European Pharmacopoeia has gained the status of a collection of reliable quality standards for medicines and their constituent components. These standards are the basis for the safe use of high-quality and affordable medicines by patients. The texts of the European Pharmacopoeia together with the certification procedures guarantee the quality of pharmaceutical substances. They give manufacturers a high-value opportunity to demonstrate adequate control over the quality of pharmaceutical substances through meeting the requirements of the relevant monographs of the European Pharmacopoeia, which helps to reduce the efforts for the regulatory authorities and to simplify the procedure for their implementation and use. Despite the fact that initially the European Pharmacopoeia was created to solve topical problems in the member-countries of the European Pharmacopoeia Commission, today its sphere of influence is much broader and is not limited to countries that have signed the Convention on its development.

The United States Pharmacopeial Convention (USP) is a non-profit, non-governmental public health organization that creates documentary and material reference standards for prescription and over-the-counter medicines that are recognized in United States law. USP also sets standards for food ingredients and dietary supplements. USP’s mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

The development of the State Pharmacopoeia of Ukraine (SPU) is based on the following principles: harmonization with the European Pharmacopoeia (EP); consideration of national specificity, self-sufficiency, National System of Pharmacopoeial Reference Standards (PhRS), feedback from users. For implementing the mentioned principles 4 main scientific areas of activity have been developed: proper elaboration of SPU texts, the National System of the PhRS, Proficiency Testing Scheme for medicines control laboratories (PTS), metrological support (in particular the validation of analytical procedures). The specificity of developing texts for SPU 1 (2001) and 2 editions (2016) have been analyzed for the following sections: general chapters, monographs for pharmaceutical substances, finished drug products, herbal medicinal products, compounded preparations, etc. The concept of further development of SPU has also been discussed.

Since the publication of the first edition of the Republic’s of Kazakhstan State Pharmacopoeia (RKSP) there have been significant changes in the requirements for the pharmacopoeia, and in the understanding of its role as the main standard of quality for medicines circulating in the country. The changes affected the Pharmacopoeia’s definition, principles of and approaches to harmonization of its requirements with the leading world pharmacopoeias (European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia), as well as the structure and content of pharmacopoeial monographs. The article dwells upon such aspects as the RKSP mission, its place in the drugs standardization system and functioning mechanism, the interrelation with the requirements of the good practices (GXP), ranking of the RKSP and the leading pharmacopoeias officially recognized in the country. In connection with the publication of Volume I of the RKSP 2.0 the article discusses the status of the Pharmacopoeia and its significance in the context of recent changes.

The development of Russia at the turn of the XVII-XVIII centuries led to the necessity of building a regular army and naval forces, capable of defending the national interests. At the same time the military health care was also developing, including its most important part, such as medicines supply to troops (forces). The publication of domestic military pharmacopoeias significantly contributed to the solution of the mentioned national task. The first edition of the military pharmacopoeia was dated 1765. Military pharmacopoeias were primarily published in Latin and then in Russian (1866). They included not only military science advanced achievements, but also civilian medical science and practices and contributed to ensuring the proper quality of medical aid to Russian soldiers.

The Russian State Pharmacopoeia XIII edition assures the quality of medicines, it is important for all the stakeholders in the sphere of the circulation of medicines, ranging from pharmaceutical development to distribution of medicinal products, both for research studies and educational process. Pharmaceutical analysis plays an essential role at all stages of medicine life cycle stages. Saint-Petersburg State Chemical Pharmaceutical Academy is a main supplier of new human resources, ready to work in modern environment, including the sphere of standardization and quality control.

Analysis of XI and XII editions of the State Pharmacopoeia of the Russian Federation proved the necessity and relevance of elaborating quality standards for immunobiological medicinal products as well as methods of their control. Assurance of safety and efficacy of this group of medicines could be achieved only by fulfilling the requirements of modern standards of quality and assuming that methods used for assessment of quality parameters of biologicals are adequate and informative. Top priorities addressed during the preparation of the XIII edition of the State Pharmacopoeia of the Russian Federation were: systematization of quality standards for biologicals on the basis of product types and methods of analysis, and harmonization of requirements for quality parameters with those of the leading world pharmacopoeias, primarily with the European Pharmacopoeia.

The article reviews the process of development and the role of national and regional pharmacopoeias in the context of globalization of world economies. Three major paths of globalization identified are: enlargement of national pharmacopoeias’ area of influence, formation of supranational (regional and supraregional) pharmacopoeias and harmonization of pharmacopoeias. The article draws a conclusion on interrelation of national and regional pharmacopoeias that aim to contribute to each other’s development. Harmonization of pharmacopoeias should follow the path of alignment of test methods and analytical procedures and at the same time accommodate national factors and priorities of countries that are involved in harmonization.

Russian requirements for main products derived from human plasma used to be laid out in several nonintegrated monographs that have been recently included into the State Pharmacopoeia of the Russian Federation, XIII edition. The present article compares requirements for the quality of human plasma products that are contained in the State Pharmacopoeia, XIII edition and in the European Pharmacopoeia.

The article illustrates the prospects of using nuclear magnetic resonance spectroscopy for complex, fast and reliable determination of key quality attributes of drug substances while performing pharmacopoeial analysis.

The new pharmacopoeial monograph «Spectrometry in the near infrared region» reflects the results of a difficult path traversed from the development of measurement and analytical techniques to the introduction of NIR spectroscopy in the practice of quality control. This review discusses the new monograph of the XIII edition of the State Pharmacopoeia in the light of existing methodological approaches developed and validated for the assessment of drug quality parameters such as identification, content uniformity, assay, etc. Special attention is paid to the formation of spectral libraries - the factor of the sample’s «age» is considered as a source of additional spectral variability. The review raises the question of the NIR spectra identity criteria. Drawing on the example of techniques developed for the evaluation of batch variability (23 medicines) it was showed that obtained values of spectral range serve as unique characteristics of each individual product and production process, defining interlot reproducibility - the less the spectral distance between the series is, the more homogeneous the products are. NIR spectroscopy was shown to be effective for quantitative analysis of solid dosage forms and liquid substances. The authors considered the principles of operation as well as prospects for the practical use of the new technology - NIR chemical imaging, combining spectral analysis and digital image.