Despite a mistake during the preparation of technetium-99m (99mTc)-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 99mTc-nanocolloid rhenium sulphide and the effect of heating on particle size. Five 99mTc-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 99mTc-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 99mTc-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.
aRadiopharmacy Unit, Departement of Pharmacy, Groupement Hospitalier Est, Hospices Civils de Lyon, 59 boulevard Pinel, 69677 Bron Cedex
bUniversity of Lyon, University Claude Bernard Lyon 1, Lyon Neuroscience Research Center, CNRS UMR5292, INSERM U1028, Lyon, France
Correspondence to Elise Levigoureux, PharmD, PhD, Radiopharmacy Unit, Departement of Pharmacy, Groupement Hospitalier Est, Hospices Civils de Lyon, 59 boulevard Pinel, 69677 Bron Cedex, Lyon, France Tel +33 042 785 5472; fax: +33 047 235 828;e-mail: firstname.lastname@example.org
Received October 24, 2018
Received in revised form January 4, 2019
Accepted January 16, 2019