Table 2.

Details for process validation of [¹⁸F]FE-PE2I produced on a Synthera^®+ synthesis module.

Test	Specification	Batch Results
Batch No.		PE2I-200513-2	PE2I-200514-2	PE2I-200520-2
Radioactivity	0.2–20 GBq at EOS	14.1 GBq	14.8 GBq	19.8 GBq
Radiochemical yield (DC)	Reported value	13%	14%	20%
[18F]Fluoride	≤5%	0.1%	0.2%	0.2%
Other 18F impurities	≤5%	1.0%	0.9%	2.0%
Radiochemical purity at EOS	≥96%	98.9%	99.0%	97.8%
Radiochemical purity after 6 h	≥90%	94.6%	94.6%	92.5%
FE-PE2I	≤1.00 µg/mL	0.45 µg/mL	0.44 µg/mL	0.28 µg/mL
Specified impurity (RT of 3.4 min)	≤1.00 µg/mL	0.15 µg/mL	0.20 µg/mL	0.13 µg/mL
Total unspecified impurities	1.00 µg/mL	n.d.	n.d.	n.d.
Total FE-PE2I and impurities	≤1.00 µg/mL	0.60 µg/mL	0.64 µg/mL	0.41 µg/mL
Molar radioactivity	Reported value	619 GBq/µmol	664 GBq/µmol	1393 GBq/µmol

n.d.—none detected.