Scientific aspects of the development of the State Pharmacopoeia of Ukraine

Abstract

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.

Keywords

• государственная фармакопея украины
• лекарственные средства
• фармакопейные стандартные образцы
• программы профессионального тестирования лабораторий
• метрологическое обеспечение
• общие и частные фармакопейные статьи
• state pharmacopoeia of ukraine
• medicines
• pharmacopoeial reference standards
• professional testing schemes
• metrological support
• general chapters and specific monographs