Quality control of the kit and injection of ⁹⁹Tc^m-TRODAT-1 as a transporter imaging agent

Objective: To study the quality control methods for ⁹⁹Tc^m-TRODAT-1 kit and injection. Methods: The appearance, pH, contents of the bases, the labeling yield, asepsis and bacterial endotoxins of ⁹⁹Tc^m-TRODAT-1 kits from three different batches were examined. The kit stability was estimated under different conditions. The transparence, pH, radiochemical purity, half-life, asepsis and bacterial endotoxins of ⁹⁹Tc^m-TRODAT-1 injection were tested. Results: The ⁹⁹Tc^m-TRODAT-1 kit and injection were both achromous and transparent, with pH values being 5.9 ± 0.1 and 5.5-7.0 respectively. The contents of stannous chloride and TRODAT-1 were stable. The labeling yield of the kit and the radiochemical purity of the injection were both ≥95%.The asepsis test demonstrated that the characters of ⁹⁹Tc^m-TRODAT-1 kit and injection were qualified. TRODAT-1 kit was stable at 0-4 ℃ for 6 months or at room temperature (20-25 ℃ )for 10 days, and the radiochemical purity of the injection was still >90% at room temperature for 8 hours. Conclusions: The quality control methods for ⁹⁹Tc^m-TRODAT-1 kit are simple and practical. The kit and injection are qualified and can be used for clinical application. (authors)