Quality control of the kit and injection of 99 Tcm-TRODAT-1 as a dopamine transporter imaging agent
10.3760/cma.j.issn.0253-9780.2011.06.015
- VernacularTitle:多巴胺转运蛋白显像剂99Tcm -TRODAT-1药盒及注射液的质量控制
- Author:
Jie, TANG
;
Zheng-ping, CHEN
;
Xiao-min, LI
;
Chun-yi, LIU
;
Xu-quan, HUANG
;
Wei-yi, LI
;
Mei-fen, ZOU
;
Xi-jie, XU
- Publication Type:Journal Article
- Keywords:
Dopamine;
TRODAT-1;
Technetium;
Quality control
- From:Chinese Journal of Nuclear Medicine
2011;31(6):414-416
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo study the quality control methods for 99Tcm-TRODAT-1 kit and injection.MethodsThe appearance,pH,contents of the bases,the labeling yield,asepsis and bacterial endotoxins of 99Tcm-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 99Tcm-TRODAT-1 injection were tested.ResultsThe 99Tcm-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 99Tcm-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.ConclusionsThe quality control methods for 99Tcm-TRODAT-1 kit are simple and practical.The kit and injection are qualified and can be used for clinical application.
