^99mTc-Radiopharmaceuticals and the Limulus Test

Abstract

At the radiopharmacy Section of the Nuclear Medicine Department of the Instituto Nacional de Nutricion, in Mexico City, all of the short half life radiopharmaceuticals are prepared and administered to the patients who are referred for organ scanning. The routine quality control of all the preparations includes radiochemical purity, labeling efficiency and sterility of the products. For a trial period the Limulus amebocyte lysate test has been used for pyrogen detection in the 99mTc-radiopharmaceuticals. A micro method was used in 204 radiopharmaceuticals including pertechnetate, sulfur colloid, pyrophosphates, pyridoxylidenglutamate, human serum albumin, and human serum albumin macroagregates. Parenteral fluids used for the kit preparation were also tested. The gel formation in the 6 pyrogenic radiopharmaceuticals (2.94%) was slow in appearing (30 min). In this trial run our results have been so promising that we have decided to make the micro Limulus amebocyte lysate test a part of our quality control routine.