SODIUM 1,2-DIPHENYL-5-BUTYL- 6-OXO-1,6-DIHYDROPYRIMIDINE-4-OLATE PRIMARY REFERENCE SAMPLE DEVELOPMENT

Abstract

The primary reference sample (RS) use is one of the conditions necessary for conducting pharmaceuticals appropriate quality control. Therefore, their development is an urgent problem for the pharmaceutical industry, especially for new biologically active compounds that can be further used as pharmaceuticals. The aim of the work is to develop a primary standard sample of new sodium 1,2-dipheny l-5-butyl-6-oxo-1,6-dihydropyrimidine-4-olate. This substance can be used in medical practice as an anti-inflammatory agent. Primary RS was obtained by additional purification of the additional pharmaceutical substance by threefold recrystallization of acetone. The work on its certification was the following: the structure was confirmed, such indicators as weight loss on drying, inorganic impurities (chlorides, sulphated ash, heavy metals), related impurities were determined. The main component quantitative content has been established using the material balance.