A two-center study for the quality control of [(18)F]FDG using FASTlab phosphate cassettes.
OBJECTIVE
The GE FASTlab radiosynthesis module is routinely used for the production of [(18)F]FDG, utilizing the commercially available phosphate cassettes. Because of the observation of a white precipitate in the product vial before the product expiry time, we re-examined the quality of the produced [(18)F]FDG solution.


METHODS
Phosphate buffered [(18)F]FDG solution was synthesized on the FASTlab and analyzed at both National Taiwan University Hospital (NTUH) of Taiwan and Royal Brisbane and Women's Hospital (RBWH) of Australia. In addition to the standard product quality control (QC), the concentration of aluminum (Al(3+)) as probable cause of the precipitations in the [(18)F]FDG solution was analyzed by inductively coupled plasma mass spectrometry (ICP-MS at RBWH) and inductively coupled plasma optical emission spectrometry (ICP-OES at NTUH), and using three semi-quantitative methods at NTUH, Advantec(®) Alumi Check Test Strip, Quantofix(®) Aluminum Test Strip and MColortest™ Aluminum Test kit.


RESULTS
The precipitates were observed in the [(18)F]FDG solution within 24 (NTUH) and 6 (RBWH) hours after the end of synthesis in 38-100 % of the batches, dependent on the batch of the FASTlab cassettes. Addition of metal-free HCl(aq) to aliquots of [(18)F]FDG containing precipitate, followed by ICP-MS analysis revealed Al(3+) concentrations of 70-80 ppm. Al(3+) concentrations of 10-12 ppm were detected in [(18)F]FDG batches that did not show any precipitation. In contrast, less than 5 ppm of the residual Al(3+) was detected by semi-quantitative methods in all batches.


CONCLUSIONS
The US (USP), British (BP), European (EP) and Japanese (JP) pharmacopeias demand that [(18)F]FDG for injection should be clear and particulate free within the given shelf-life/expiration time. To avoid Al-phosphate precipitation within the product expiry time, FASTlab citrate cassettes, rather than phosphate cassettes, should be used for [(18)F]FDG production. Although testing for Al(3+) is not listed in the [(18)F]FDG monographs of the USP, BP and EP, residual Al(3+) levels should be considered in the interests of patient safety.
PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, 7, Chung-Shan S. Road, Taipei, 100, Taiwan. careyyh@ntuh.gov.tw.
Ya-Yao
YY
Huang
Department of Nuclear Medicine, Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4027, Australia.
Stephen
S
Taylor
Department of Radiation Physics, Linköping University, Linköping, Sweden.|Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
Jacek
J
Koziorowski
Molecular Imaging Center, National Taiwan University, 1, Sec. 4, Roosevelt Road, Taipei, 106, Taiwan.
Yu-Ning
YN
Chang
PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, 7, Chung-Shan S. Road, Taipei, 100, Taiwan.
Wei-Hua
WH
Kao
PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, 7, Chung-Shan S. Road, Taipei, 100, Taiwan.|Molecular Imaging Center, National Taiwan University, 1, Sec. 4, Roosevelt Road, Taipei, 106, Taiwan.
Kai-Yuan
KY
Tzen
PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, 7, Chung-Shan S. Road, Taipei, 100, Taiwan.|Molecular Imaging Center, National Taiwan University, 1, Sec. 4, Roosevelt Road, Taipei, 106, Taiwan.|PET Center, Department of Nuclear Medicine, Tri-Service General Hospital, 325, Sec. 2, Cheng-Kung Road, Neihu, Taipei, 114, Taiwan.
Chyng-Yann
CY
Shiue
D011232:Chemical Precipitation; D019788:Fluorodeoxyglucose F18 / Q000138:chemical synthesis* / Q000737:chemistry*; D010710:Phosphates / Q000737:chemistry*; D011786:Quality Control; D011854:Radiochemistry / Q000592:standards*
D010710:Phosphates; D019788:Fluorodeoxyglucose F18
Cassette; FASTlab; Phosphate; Precipitate; [18F]FDG