Quality control of a detector for the calculations of radiopharmacokinetic parameters of 99mTc-glucarate in rats

Good manufacturing practices specify that a well-type scintillation NaI(Tl) crystal detector has to be validated in order to detect radioactivity from any radiopharmaceutical used to obtain radiopharmacokinetic parameters. A 5 cm well-type NaI(Tl) scintillation detector was coupled to a multi-channel analyzer centered at the 140 keV 99mTc peak with a 20% window. The area represents counts per minute (cpm). All the net cpm were decay corrected. The activity source was 99mTc-glucarate developed as an imaging agent for acute myocardial infarction. Wistar rats were injected in a tail vein with 0.1 ml (3.7 MBq) of 99mTc-glucarate solution and 13 blood samples were taken. The cpm were the input data for the WINNONLN program which calculates radiopharmacokinetic parameters. The detector's efficiency for 99mTc was 15.03% and the sensitivity 1.12 kBq/ml in plasma. The response was linear between 0.31-14.3 kBq/ml of 99mTc-glucarate. The maximum assay variation coefficient was 2.79 and recovery of 99mTc-glucarate in plasma was 99.8% ± 0.2%. LOD was 0.31 kBq and LOQ 1.12 kBq in plasma samples. 99mTc-glucarate follows a two-compartment model of distribution with Vd of 21.74 ml ± 2.71 ml; a Vdss of 74.36 ml ± 12.67 ml; t1/2α 0.74 h ± 0.19 h; t1/2β 18.98 h ± 4.36 h; AUC = 32.75 μCi/min x ml ± 3.73 μCi/min x ml; MRT 24.35 h ± 5.51 h and total clearance 3.05 ml/h ±0.35 ml/h. The well-type detector fulfills the quality system requirements and the radiopharmacokinetic parameters for 99mTc-glucarate in rats are reliable. (author)