Objective: The present study had determine the impact of prolonged storage in a cartridge or
syringe on the quality of the [18F]-radiopharmaceuticals used in our center [18F]fludeoxyglucose and
[18F]fluorocholine). [18F]-radiopharmaceuticals registered as ready-to-use drugs are prepared in multidose
flasks. When the change of packaging must be made extemporaneously for the preparation of
patient unit doses in a syringe or cartridge, this is under the responsibility of radiopharmacists. As drug
quality in medical devices (syringe or cartridge) is not evaluated during the marketing authorization of
such radiopharmaceuticals, an evaluation of drug stability in such devices seems interesting. In addition,
if there are difficulties in patient care (placement of the catheter, lack of personal, etc.) or equipment
problems (technical issue with the automated dispenser delaying the delivery of the prepared
dose), the contact time of [18F]-radiopharmaceuticals with the medical devices (cartridge or syringe)
Methods: Appearance, pH, radiochemical purity, sterility and endotoxin tests were made according the
current European Pharmacopoeia. Adsorption tests were made according the literature.
Results: There was no drug absorption of [18F]fludeoxyglucose or [18F]fluorocholine after 1.5h,
which may be related to their hydrophilic nature. No drug radiolysis was observed even after dilution
of the radiopharmaceuticals (appearance, pH, and radiochemical purity were unchanged). No impurity
from medical devices (cartridge or syringe) was observed, and microbiological aspects remained in
specification of the current European Pharmacopoeia.
Conclusion: These radiopharmaceuticals repackaged in plastic medical devices retained their quality
after dispensing and prolonged storage.