Drug quality evaluation and control involve extensive use of biological methods in addition to chemical, physico-chemical and microbiological ones in order to ensure drug identity, purity and safety. Basic requirements for biological testing criteria are stated in the State Pharmacopoeia of the Russian Federation, however some aspects of testing are not described in sufficient detail and depend on the nature of a medicine to be tested. The present article describes basic requirements for introducing «Bacterial endotoxins» and «Abnormal toxicity» parameters to normative documentation. It also outlines basic aspects of test conditions validation and determination of an adequate level of drug quality standards.

The article considers the importance of International Nonproprietary Names (INNs) and group names in the development of common information standards for the industry in the light of creation of the EurAsEC market and shared information space. The necessity to define the rules for assigning group names to herbal drugs results from the requirement introduced to Federal Law No. 61-FZ «On circulation of medicines», making it obligatory to specify group names on drug labels in the absence of INNs in the State Register of pharmaceutical products. The article covers the development of the methodological approach to establishing group names for the mentioned group of medicinal products.

At present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy implementation principles. One of the appropriate solutions is the introduction of general chapters and monographs to the State Pharmacopoeia. The structure of the Second Edition of the State Pharmacopoeia of Ukraine includes five general pharmacopoeia chapters for compounded preparations. The next work step is the development of the pharmacopoeia concept for the elaboration of pharmacopeia monographs for officinal prescriptions and their introduction to the national part of the pharmacopoeia. In order to fulfill the mentioned task, the approaches for assessing the quality of extemporaneous preparations should be approved, the quality control methods should be developed and validated, the validation of technological process should be performed, and the stability and the expiration dates should be examined. The algorithm and the stages of the elaboration of pharmacopeia monographs for compounded preparations are described in the article, the structure of monographs is proposed, the examples of monographs for intra pharmaceutical preparations and concentrated solutions are given.

The article considers modern requirements for standardization of homoeopathic raw material and substances. The study included the analysis of a range of raw materials of plant, animal, mineral and chemical origin, which are used for the production of homeopathic substances. The article describes basic ways of processing raw material for producing homeopathic substances and basic principles of the quality control of raw materials in different countries. It was revealed that there was a difference in the composition of substances used under the same name, as well as in methods of preparation of homeopathic substances. The authors formulated the main approaches to standardization of homoeopathic raw material that were used in the elaboration of monographs on homeopathic products for the State Pharmacopoeia of the Russian Federation.

The second edition of the Republic of Kazakhstan State Pharmacopoeia (RKSP 2.0) is the practical implementation of the principles of continuous development, harmonization and updating. Features of RKSP harmonization with the leading pharmacopoeias of the world (European Pharmacopoeia, British Pharmacopoeia, United States Pharmacopeia) determine the structure of its chapters and monographs, as well as used types and mechanisms of harmonization. The article reflects the changes made in general chapters and monographs of the Volume I of the RKSP 2.0 and which will be included in specific monographs of the Volume II of the RKSP 2.0.

The article highlights the issues related to indication of drug storage conditions. It describes the approaches to indicating temperature requirements and to interpretation of the term «dry place». The article also provides the recommendations on setting the storage conditions for sterile drugs after dilution. It was concluded that the harmonization and standardization of the definitions related to storage conditions, as well as indication of the required warnings on packages, eventually help to ensure the quality, proper therapeutic effect and safety of the product during the shelf life.

Processing of interferon gamma antibodies, which involves gradual reduction of the concentration, induces the formation of deuterium-stabilized giant heterophase clusters (GHCs) of water characterized by the specific size spectrum and kinetics of formation/decay. An investigation into the formation/decay kinetics of GHCs of water by a 2D light scattering method using topological descriptors allows distinction between various dilutions of protein nanoparticles, in particular interferon gamma antibodies, and similar dilutions of glycine buffer (control). The possibility of analytical control of highly diluted pharmaceuticals is currently under discussion. The method may therefore find potential applications in the manufacturing control of ultrahighly diluted pharmaceuticals and express quality analysis.

Common topical issues of the quality assessment of pharmaceutical substances in terms of «Assay», are related to the compliance of actual test results to assay requirements as well as to the proper elaboration of normative documents (completeness, accuracy of the descriptions of analytical methods) and the appropriate test conditions validation with the materials in the scope of the mentioned regulatory documents. It was shown that an objective assessment of the quantitative content of an active ingredient in pharmaceutical substance of synthetic or mineral origin depends largely on the choice of the analytical method, use of the appropriate techniques considering the materials included in the monographs of the State Pharmacopoeia the Russian Federation and leading foreign pharmacopoeias.

The article describes a simple method for purifying N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine for further use as a standard for quantitative determination of genotoxic impurities substance imatinib mesylate. Experimentally proved choice of sorbent used for purification of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine. The advantage of column chromatography on neutral alumina prior to crystallization methods presented in the literature. Comparative chromatographic and spectral characteristics of N-(5-amino-2-methylphenyl)-4-(3-pyridyl)-2-pyrimidineamine before and after purification. NMR spectroscopy evaluated quantitative content of the target substance in the purified sample.

The article provides with a brief historical background for the editions of the State Pharmacopoeia. It characterizes the Russian State Pharmacopoeia of the XIII edition. It was shown that the Russian State Pharmacopoeia, being an essential part of the drug standardization system, also carries an important educational function. Guality standards and methods of analysis, systematization of knowledge, definitions and classifications regulated by the Pharmacopoeia, not only form the knowledge base, but also define the scientific veiw for future experts.

The article presents the results of determining aluminum in Chamomile flowers by domestic manufacturers. A comparative analysis of the ability to accumulate aluminum for various medicinal plants has been performed. It has been shown that chamomile is defined by increased resistance to excessive concentrations of aluminum in comparison to other herbal substances.

The article analyses the results of dissolution testing of Betahistine hydrochloride 16 mg tablets using both manual and automatic sampling. The analysis showed that the data obtained with manual sampling are statistically identical to those obtained with automatic sampling in terms of average values and variance (with significance level α = 0,05), which confirms that the automation of the dissolution test does not affect the variability of test results.

The possibility of using chromatographic columns Zorbax SB CN 150´4,6 mm (5 μm) for separation of hydroxycarbamide (hydroxyurea) and its impurity urea has been investigated. The mixture of acetonitrile and water has been used as a mobile phase used. Separation of analytes on nitrile columns under the conditions of hydrophilic interaction liquid chromatography is possible only when the content of acetonitrile in the mobile phase is more than 90 %. When performing chromatographic procedure with Zorbax SB CN on nitrile column, the change in elution order of hydroxycarbamide and urea has been detected, compared to the elution order on amino column Zorbax NH₂.

Rational use of existing antimicrobial drugs is considered as the main way of reducing the resistance of microorganisms. The study aims to identify the current state of international and Russian formularies that cover antibacterials for systemic use (group J01 of the ATC-classification), and perform their comparative analysis. The study included analysis of representation of antibacterial agents in the formularies (the List of Vital and Essential Medicines, the WHO Model List of Essential Medicines, the British National Formulary) and treatment standards and comparison of obtained data with the State Register of medicines. Comparative analysis of the formularies makes it possible to identify 21 most significant antibacterial drugs included into the three formularies investigated.