Özet:

Aim. To study thermal gravimetric analysis (TGA) application for the reference standards certification, considering the uncertainty metrological concept of the State Pharmacopoeia of Ukraine. Methods. Thermogravimetric analysis, mathematical statistics methods. Results. TGA application to determine volatile impurities for the reference standards certification was studied, considering the requirements for making the reliable conclusion about quality of medicines (95 %). Requirements to the volatile impurities content uncertainty were formulated. It has been found, that measurement uncertainty evaluation for the volatile impurities determination, using TGA method, meets the strictest requirements for the pharmaceutical reference standards certification. Conclusion. It has been shown, that TGA method allows the use of minimum weighed portions, typical for pharmaceutical analysis practice: 10 mg for quantitative determination, 5 mg or less for purity tests, 10 mg for homogeneity tests, which is the strictest requirement for pharmaceutical reference standards Author Biographies Дмитрий Анатольевич Леонтьев, Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085 Candidate of Pharmaceutical Sciences, Senior Research Fellow, Deputy Director (on Science), Head of the Department Department of Validation and Reference Standards

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