Gubar S. Standardization of the results estimation of pharmaceutical laboratories professional testing by the example of pharmacopoeial methods of analysis

The thesis is devoted to the standardization of the results estimation of pharmaceutical laboratories in Ukraine within PTP-6 and PTP-7 using pharmacopoeial methods of analysis: non-aqueous titration, loss on drying and TLC and to the implementation of elements of the quality management system of laboratories in drug quality control using the methods and instruments of risk management. The criteria for estimation of testing results have been developed on the basis of the research, the methods for quantitative determination of 3-(2,2,2-trimethylhydrazinium) propionate content by the method of non-aqueous titration and the content of related substances by the method of TLC in the active pharmaceutical ingredient and the manufactured drug “Metonat” have been developed and validated, the algorithm for assessment and control of critical factors have been developed and practically approved using the results of laboratories within the PTP-6 and PTP-7.