Radiochemical purity of technetium-99m-nanocolloid rhenium sulphide is not influenced by heating.

Laura Galland,Claire Bolot, Sylvain Rosinski, Aurélie Bruno, Sandra Forel,Valentine Bréant,Elise Levigoureux

NUCLEAR MEDICINE COMMUNICATIONS(2019)

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摘要
Despite a mistake during the preparation of technetium-99m (Tc)-nanocolloid rhenium sulphide (Nanocis) because of lack of heating, the apparent radiochemical purity (RCP) of this product was correct. The objectives of this study were to evaluate the impact of absence of heating on the RCP of Tc-nanocolloid rhenium sulphide and the effect of heating on particle size. Five Tc-Nanocis were prepared according to the manufacturer's instructions and five others were realized without any heating step. Quality controls were performed for each preparation. To evaluate the effect of heating on particle size, preparations were filtered through a 0.22 µm sterilizing membrane filter before and after 30 min of heating. The radioactivity was measured before and after the filtration. The results showed that absence of heating does not influence the apparent RCP of Tc-nanocolloid of rhenium sulphide. In terms of the particle size, 72% of particles had a diameter less than 0.22 µm before heating, as opposed to 21% after heating. To conclude, this study underlines a problem of quality control of the Tc-nanocolloid rhenium sulphide preparation, which cannot detect a lack of heating and can lead to the release of preparations that would not be suitable for scintigraphy.
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nuclear pharmacy,quality control,radiochemical purity,technetium-99m-nanocolloid rhenium sulphide
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