Supplement 7 (in 2 volumes) to the 2nd Edition of the State Pharmacopoeia of Ukraine (SPhU 2.7) is put into effect from July 1, 2024, by order of the Ministry of Health of Ukraine, dated May 2, 2024, No. 754.
SPhU 2.7 continues the main development directions started in previous issues of SPhU 2nd Edition. These include the introduction of new texts and the revision of existing texts. Considerable attention is paid to national texts and additions.
Despite the challenging wartime period, the Ukrainian Scientific Pharmacopeia Center for Quality of Medicines maintained and expanded cooperation with the European Pharmacopeia, the Pharmacopeias of the USA, Great Britain, Germany, and the International Pharmacopeia. The experience of national pharmacopoeias of the countries that are members of the European Pharmacopoeia presents an interest and is taken into account. The strategic direction of the SPhU development is a gradual transition to the direct use of the texts of the European Pharmacopoeia with a focus on the development of national texts that do not contradict the European texts but reflect the specifics and needs of the domestic pharmaceutical industry.
Along with texts introduced or revised according to changes in Ph. Eur., new or supplemented national texts were introduced, including:
5.3.N.1. STATISTICAL ANALYSIS OF CHEMICAL TEST RESULTS
5.3.N.2. VALIDATION OF ANALYTICAL PROCEDURES AND TESTS
5.3.N.3. QUALITY ASSURANCE
A large number of leading scientists, drug manufacturers and representatives of the pharmaceutical community participated in the development of SPhU 2.7.