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A two‐center study for the quality control of [18F]FDG using FASTlab phosphate cassettes

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Abstract

Objective

The GE FASTlab radiosynthesis module is routinely used for the production of [18F]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 [18F]FDG solution.

Methods

Phosphate buffered [18F]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 (Al3+) as probable cause of the precipitations in the [18F]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 [18F]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 [18F]FDG containing precipitate, followed by ICP-MS analysis revealed Al3+ concentrations of 70–80 ppm. Al3+ concentrations of 10–12 ppm were detected in [18F]FDG batches that did not show any precipitation. In contrast, less than 5 ppm of the residual Al3+ was detected by semi-quantitative methods in all batches.

Conclusion

The US (USP), British (BP), European (EP) and Japanese (JP) pharmacopeias demand that [18F]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 [18F]FDG production. Although testing for Al3+ is not listed in the [18F]FDG monographs of the USP, BP and EP, residual Al3+ levels should be considered in the interests of patient safety.

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Authors and Affiliations

  1. PET Center, Department of Nuclear Medicine, National Taiwan University Hospital, 7, Chung-Shan S. Road, Taipei, 100, Taiwan

    Ya-Yao Huang, Wei-Hua Kao, Kai-Yuan Tzen & Chyng-Yann Shiue

  2. Department of Nuclear Medicine, Royal Brisbane and Women’s Hospital, Butterfield St, Herston, QLD, 4027, Australia

    Stephen Taylor

  3. Department of Radiation Physics, Linköping University, Linköping, Sweden

    Jacek Koziorowski

  4. Department of Medical and Health Sciences, Linköping University, Linköping, Sweden

    Jacek Koziorowski

  5. Molecular Imaging Center, National Taiwan University, 1, Sec. 4, Roosevelt Road, Taipei, 106, Taiwan

    Yu-Ning Chang, Kai-Yuan Tzen & Chyng-Yann Shiue

  6. PET Center, Department of Nuclear Medicine, Tri-Service General Hospital, 325, Sec. 2, Cheng-Kung Road, Neihu, Taipei, 114, Taiwan

    Chyng-Yann Shiue

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  1. Ya-Yao Huang
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  2. Stephen Taylor
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Correspondence to Ya-Yao Huang.

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Huang, YY., Taylor, S., Koziorowski, J. et al. A two‐center study for the quality control of [18F]FDG using FASTlab phosphate cassettes. Ann Nucl Med 30, 563–571 (2016). https://doi.org/10.1007/s12149-016-1097-4

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  • DOI: https://doi.org/10.1007/s12149-016-1097-4

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