Quality control test for 177Lu-DOTAELA

Abstract

This article provides a brief overview of 177Lu-DOTAELA (177Lu -1,4,7,10- tetraazacyclododecane-1,4,7,10- tetraacetic acid – 4-[[(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-[[2-fluoro-
6-(trifluoromethyl)phenyl] methyl]-4-methyl-2,6 dioksopirimidin-1-yl]-1-phenylethyl] amino] butanoic acid) quality control based on practical experience. Over the past few years, radionuclide 177Lu has attracted considerable attention and demonstrated great perspectives in the scientific, commercial and clinical communities for application in various therapeutic procedures. Requirements for quality control of radiopharmaceuticals can be found in volume 3 of the State Pharmacopoeia of the Republic of Kazakhstan (SF RK) which is the main regulative document in our country, in the absence of specific monographs and articles in the national Pharmacopoeia it is allowed to use and refer to the Pharmacopoeia of other countries (USA, Japan, UK and Europe). The main requirements for radiopharmaceuticals: pH; radionuclide identification; radiochemical purity; residual solvents; chemical purity; sterility and bacterial endotoxins; checking the integrity of the filter membrane. It should also be noted that there are differences in the quality requirements of some monographs of radiopharmaceuticals in the Pharmacopoeia of different countries. Considering above, during development of the quality control procedure we have to use several regulatory sources. The solution to this problem can be the harmonization of Pharmacopoeia of the Member-States of the Eurasian Economic Union. The process of testing the methodology of quality control is time-consuming and includes many tasks, especially in the area of new radiopharmaceuticals development.