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The multidisciplinary context of the State Pharmacopoeia of Ukraine in drug quality systems was justified through an interdisciplinary study of pharmaceutical business organization, quality control, standardization, drug technology, management, marketing, forensic pharmacy, medical and pharmaceutical law in the system of legal relations "doctor-patient-pharmacist-lawyer" during state formation and implementation of Ukraine's integration processes into the WTO and the EU. Noted that the State Pharmacopoeia of Ukraine was from the first of the CIS countries, fully harmonized with the European Pharmacopoeia, takes into account national specificities, the Constitution of Ukraine, legislation on normative legal acts of Ukraine. Proven that, according to international assessments, the State Pharmacopoeia of Ukraine is the best National Pharmacopoeia in the post-Soviet space concerning the modern requirements of the WTO and WHO regarding quality and safety systems of medicines.

Provision to every citizen, patient, and person in the system of legal relationship "doctor-patient-pharmacist" the right to life, health, and safety during the circulation of vital medicinal products of all clinical and pharmacological, nomenclature and legal, classification and legal groups, guaranteed by created in in Ukraine the system of standardization and quality control of medicines. The system of standardization and quality control of medicines includes the National System of Standardization of Medicines in Ukraine (1992); The system of state control of the quality of medicinal products (1992); Programs for the development of generic drugs in Ukraine (1995); The school of standardization and quality control of medicinal products; Center for standardization, metrology, and quality control in Ukraine. Ukraine got observer status in the European Pharmacopoeia in 1998. The National Pharmacopoeia of Ukraine (2001) appeared 6-7 years earlier than other countries (Belarus, Kazakhstan, Russian Federation). Two editions of the State Pharmacopoeia of Ukraine, totaling thirteen volumes and 7,208 pages, was developed as of 2022 and put into effect. The State Pharmacopoeia of Ukraine is fully harmonized with the European Pharmacopoeia and is the basis of the entire system of standardization and quality control of medicinal products in Ukraine. A pharmacopeial language (Ukrainian terminological apparatus), which did not exist before, was developed, and implemented. The State Pharmacopoeia of Ukraine is an important reference-informational and educational-methodical material for pharmaceutical enterprises, health care institutions, pharmacies, universities of medical and pharmaceutical profiles. The national system of pharmacopeial standard samples largely meets the needs of national control laboratories, and ranks the 6th in the world in terms of the number of pharmacopeial standard samples. The State Pharmacopoeia of Ukraine is the only pharmacopoeia in the world in which standardized validation procedures have been introduced, which has turned validation into an ordinary routine procedure. Ukraine acquired the status of a full member of the European Pharmacopoeia in 2013. European standards for the quality of medicinal products are in force in Ukraine. The State Pharmacopoeia of Ukraine acquired voting membership in the Pharmacopoeia of the United States in 2010. In order to develop texts that are not in the European Pharmacopoeia (in particular, monographs on ready medicines), the State Pharmacopoeia of Ukraine concluded Agreements with the leading pharmacopoeias of the world – the USA in 2010 and Great Britain in 2013. A powerful market, world- and European-level pharmaceutical industry was created, which was included in the field of health care, which provided the pharmacy network and health care institutions with modern, effective, safe, high-quality, and economically available drugs. The system of legal relations "doctor-patient-pharmacist" is based on the principles of pharmaceutical law, the Constitution of Ukraine, laws, and regulatory acts, timely ensures the right of a person, citizen, and patient suffering from various health disorders in accordance with the ICD-11, on life and health.

Aim . The paper intends to frame and pilot the optimised science-based principles of the assay transfer. Materials and methods . The research was performed on desloratadine film-coated tablets, using an analytical balance Mettler Toledo XP 205DR and Class A volumetric glassware. Absorbance readings were measured on a UV-Vis spectrophotometer Lambda 25. Results and discussion . The concept of method transfer that complements the conventional approach to validation with the lifecycle initiative and the metrological base of the State Pharmacopoeia of Ukraine was substantiated, following which the transfer of the spectrophotometric procedure for desloratadine assay was conducted. For the batch intended for the transfer, the budget of analytical and technological variability was balanced. The deviation of a single assay result from the grand mean was used as the criterion for accuracy in the transfer. The requirement for the one-sided confidence interval for assay result runs not to exceed the target uncertainty of the procedure was used as the criterion for precision. The control strategy requirements for variability sources and the analytical target profile requirements for precision and accuracy were met in the receiving unit. Conclusion . The paper discusses the premise and advocates an alternative approach to the method transfer. Precision is proposed not to study during the transfer (in the short-term experiment) but assess from the stability data (in the long-term experiment). Compliance with the normal analytical practice (the maximum permissible variability attributed to analysts and analytical instruments) allows narrowing down the transfer design to the confirmation in the minimal experiment that the amplitude of variability sources lies within the predefined range

Aim. This work aimed to validate an assay procedure for desloratadine tablets by direct spectrophotometric method. Materials and methods. A pilot-scale batch of the pharmaceutical preparationAlerdez, film-coated tablets containing 5 mg of desloratadine, manufactured by PJSC SIC “Borshchahivskiy CPP”, Ukraine, was used as an object of the study. A UV-Vis spectrophotometer Lambda 25 (Perkin Elmer), analytical balance Mettler Toledo XP 205DR, and class A volumetric apparatus were used in the study. Validation of the procedure was performed following the metrological approach of the State Pharmacopoeia of Ukraine (SPhU), whose requirements for the target uncertainty and bias, which rest on the risk assessment of making incorrect decisions on compliance (a confidence level of 95 %), were translated into criteria for all validation characteristics recommended by ICH. All calculations were made in normalised coordinates. The linearity, accuracy and precision (repeatability) were studied in a single experiment using nine different concentrations that uniformly covered the range of ±30 % from the nominal concentration of desloratadine. For validation of the procedure, an SPhU reference standard of desloratadine was used. Results. The experiment design and validation characteristics being tested were in full compliance with ICH Q2(R1) recommendations. All performance characteristics conformed to the criteria recommended by the SPhU. Requirements for the target uncertainty (1.6 %) and bias for any systematic source of variation (≤0.51 %, negligible in relation to 1.6 %) were established. The analytical procedure was specific – the absorbance from the placebo solution was insignificant (A %=0.36). The procedure met the requirements for linearity, accuracy, and precision at the repeatability level. The residual standard deviations0was 0.34 (≤ 0.84); correlation indexRcwas 0.9998 (≥0.9991); interceptаwas 0.045 (less than its confidence interval ∆a=1.14). The confidence interval for recovery∆Z, which was used as a precision estimate, was 0.55 % (less than the target uncertainty). The mean recovery, which was used as an accuracy estimate, statistically insignificantly deviated from 100% (|Zmean‑100| = 0.022 %). The confidence interval for the intermediate precision∆intrawas 0.33 % (less than the target uncertainty). The developed analytical procedure was found to be robust. Conclusions. A spectrophotometric procedure suitable for the assay of desloratadine in film-coated tabletsAlerdezwith content limits of ±5 % was validated by the SPhU approach.

Aim.The increase in the pharmaceutical market of Ukraine of the range of medicines leads to stricter requirements for their quality. According to the requirements of international standards ISO, ICH, GMP, current legislation of Ukraine and the State Pharmacopoeia of Ukraine, generic drugs must be equivalent, and the analytical methods used for quality control, validated or verified. One of the available methods of analysis used both in pharmacy conditions and in quality control laboratories at enterprises and in independent control and analytical laboratories is absorption spectrophotometry in the ultraviolet and visible areas. Materials and methods.The method of absorption spectrophotometry in the ultraviolet and visible areas is used to quantify the active pharmaceutical ingredients in finished tablet dosage forms when the quantitative determination performed and when conducting pharmaco-technological tests, such as "Dissolution" and Uniformity of dosage units". Results.To use the method of absorption spectrophotometry for the quantitative evaluation of active pharmaceutical ingredients in finished drugs, it is necessary to verify the proposed methods and examine such validation characteristics as specificity, linearity, accuracy and precision of the proposed methods. At the same time, the uncertainty of the results of the analysis DAs,, expressed as a one-sided confidence interval for the probability of 95 %, and which consists of the uncertainty of sample preparation (DSp) and the uncertainty of the final analytical operation (DFAO), must not exceed the maximum permissible total uncertainty of the analysis (maxDAs). Conclusions.The approaches of the State Pharmacopoeia of Ukraine to the methods for determining the quantitative content of active ingredients in tablets during the tests "Quantitative determination", "Dissolution", Uniformity of dosage units" were studied. The procedure has been proposed for verifying methods for quantitative determination of manufactured drugs using absorption spectrophotometry according to the requirements of the 2nd edition of the State Pharmacopoeia of Ukraine