Quality control of the kit and injection of 99 Tcm-TRODAT-1 as a dopamine transporter imaging agent / 中华核医学杂志
Chinese Journal of Nuclear Medicine
;
(6): 414-416, 2011.
Article
in Chinese
| WPRIM
| ID: wpr-643169
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Journal of Nuclear Medicine
Year:
2011
Type:
Article
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