A Multi-institutional In Vitro Evaluation of Commercial ^99mTc Macroaggregated Albumin Kits

Abstract

Quality control testing of ^99mTc macroaggregated albumin injection, U.S.P. (Tc-MAA) should include determination of radiochemical purity and particle size. We evaluated the variability in these parameters in vitro among products from five manufacturers of ^99mTc-MAA kits. Radiochemical purity, as determined by supernatant activity determinations, varied from 0.5% to 16.0%. Although mean particle size was similar for all products tested, actual particle size distribution varied considerably among products tested.