Reference materials of composition biologically active substances

Abstract

To ensure the uniformity of measurements and ensure metrological traceability of the measurement results in the field of ensuring the uniformity of measurements state regulation, including in the areas of healthcare and pharmaceuticals, reference materials of the composition, properties and structure of substances are needed. Currently, the Federal Information Fund of the Russian Federation has approximately 9000 reference materials, among which only about 30 reference materials are intended for use in pharmaceuticals and medicine. This amount is clearly not enough for full metrological support of these areas. This article describes the main stages and results of research and development of starting pharmaceutical substances reference materials of amphotericin B, natamycin, olivomycin A. The main substances of the created reference materials are identified. Mass fractions of related compounds, residual organic solvents and inorganic impurities (iron cations and heavy metals) were determined. The results of the work were used to confirm the reference materials types of the starting pharmaceutical substances amphotericin B, natamycin, olivomycin A.