GMP production of 6-[18F]Fluoro-l-DOPA for PET/CT imaging by different synthetic routes: a three center experience

EJNMMI Radiopharmacy and Chemistry

Table 1 Average values of selected production and QC parameters for batches of [¹⁸F]1 produced at the three different productions sites. Errors indicate standard deviations of the mean. The value for the enantiomeric purity at HUH includes productions where the alkylation is carried out at − 20 °C and at room temperature (rt)

	AUH	OUH	HUH
non-d.c. RCY	9.3 ± 4.2%	5.6 ± 0.3%	30 ± 8%
Radiochemical purity	97.4 ± 1.4%	98.4 ± 0.16%	99.8 ± 0.5%
[¹⁸F]F⁻	1.06 ± 0.84%	0.74 ± 0.1%	~ 0.2%^a
Enantiomeric purity (l-isomer)	99.4 ± 0.2%	99.9 ± 0.06%	98.6 ± 0.4% (− 20 °C)
Enantiomeric purity (l-isomer)	99.4 ± 0.2%	99.9 ± 0.06%	96.7 ± 0.8% (rt)
Molar activity	52 ± 15 MBq/μmol	236 ± 28 GBq/μmol	189 ± 56 GBq/μmol
[¹⁹F]1	1.42 ± 0.68 mg/ml	0.32 ± 0.056 μg/ml	0.60 ± 0.13 μg/ml
6-OH-DOPA	3.84 ± 1.6 μg/ml	3.6 ± 0.18 μg/ml	Not detected

^aThe standard deviation of the mean is larger than the mean itself, making the value statistically insignificant