Reference Materials of Composition of Biologically Active Substances
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MEDICAL AND BIOLOGICAL MEASUREMENTS REFERENCE MATERIALS OF COMPOSITION OF BIOLOGICALLY ACTIVE SUBSTANCES E. V. Kuliabina,1 A. N. Tevyashova,2 S. E. Solov’eva,2 O. N. Melkova,1 and E. A. Guskova1
UDC 620.11:006].002
To ensure the uniformity of measurements and metrological traceability of measurement results in state regulation of ensuring the uniformity of measurements, including in healthcare and pharmaceuticals, reference materials of 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 insufficient for full metrological support of these areas. This article describes the main stages and results of research and development of reference materials of starting pharmaceutical substances 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 material types of the starting pharmaceutical substances amphotericin B, natamycin, olivomycin A. Keywords: reference materials, reference materials of composition, amphotericin B, natamycin, olivomycin A.
Introduction. A reference material (RM) is a material that is sufficiently homogeneous and stable with respect to certain properties to be used when measuring or evaluating qualitative properties in accordance with the intended purpose [1]. Reference materials are used in various areas of state regulation to ensure the uniformity of measurements for transference of the magnitude of values, calibration, verification of measuring instruments, certification and validation of measurement procedures. Calibration and verification of quantitative analysis instruments is performed using RMs, for example, such as biological sample analyzers, biochemical analyzers, electrolyte and blood gas analyzers, mass spectrometers, chromato-mass spectrometers for measuring the mass concentration of the analyte in biological samples, pharmaceutical substances, to determine the molecular weights of peptides and proteins, etc. The results of quantitative measurements of the content of various substances in biological material (fluids and tissues of the human body) obtained using RMs are used for diagnosing diseases, conducting expert studies in forensic medical examinations, and also for examining citizens. All results must comply with the provisions of the Federal Law from November 21, 2011 No. 323-FZ, “On the Basics of Protecting Citizens’ Health in the Russian Federation,” and the standard GOST 318862012, “Principles of Good Laboratory Practice (GLP).” Performing quantitative measurements in pharmaceuticals is necessary to establish compliance of medicines with the XIV edition of the State Pharmacopoeia of the
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