Table 5.

Results of [¹⁸F]F-PSMA-1007 representative batches obtained with [¹⁸F]F^- from different suppliers.

Parameter	Method	Acceptance Criteria	Batch 14/02/19 Sup. 1	Batch 15/03/19 Sup. 1	Batch 12/04/19 Sup. 1	Batch 09/07/20 Sup. 2	Batch 30/07/20 Sup. 2	Batch 06/08/20 Sup. 2
[18F]F-PSMA-1007 Activity	Dose Calibrator	7000–18,200 MBq	7030 MBq	9990 MBq	18,200 MBq	7600 MBq	8800 MBq	10,260 MBq
Radioactive Concentration	Dose Calibrator	300–791 MBq/mL	305.6 MBq/mL	434.3 MBq/mL	791 MBq/mL	330 MBq/mL	382 MBq/mL	446 MBq/mL
Volume		23 mL	23 mL	23 mL	23 mL	23 mL	23 mL	23 mL
Appearance	Visual test	Clear and Colorless Solution	Complies	Complies	Complies	Complies	Complies	Complies
Identification	γ-Spectrometry	Peaks at 0.511 Mev and 1.022 Mev	Complies	Complies	Complies	Complies	Complies	Complies
	Half-Life	105–115 min	Complies	Complies	Complies	Complies	Complies	Complies
Identification	HPLC	TR [18F]F-PSMA-1007 ± 0.5 min TR PSMA-1007 Reference Standard	13.5 min	13.5 min	13.6 min	13.5 min	13.5 min	13.6 min
Radiochemical Purity	TLC	[18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95%	0.3% 99.7%	0.9% 99.1%	0.2% 99.8%	0.7% 99.3%	0 100%	0.6% 99.4%
Radiochemical Purity	HPLC	[18F]F- ≤ 5% [18F]F-PSMA-1007 ≥ 95%	n.p. 98.3%	n.p. 98.1%	n.p. 97.7%	n.p. 97.9%	n.p. 98.5%	n.p. 98%
Chemical Purity	HPLC	PSMA-1007 ≤ 0.1 mg/Vmax Sum of Impurities ≤ 0.5 mg/Vmax	Complies	Complies	Complies	Complies	Complies	Complies
	TLC	TBA ≤ 260 μg/mL	Complies	Complies	Complies	Complies	Complies	Complies
Ethanol	GLC	≤10% P/V	Complies	Complies	Complies	Complies	Complies	Complies
DMSO	GLC	≤5000 ppm	Complies	Complies	Complies	Complies	Complies	Complies
pH	pH Strips	4.8–8.5	7.5	7.5	7.5	7.5	7.5	7.5
Filter Integrity	Bubble Point Test	≥50 psi	≥50 psi	≥50 psi	≥50 psi	≥50 psi	≥50 psi	≥50 psi
Radionuclidic Purity	γ-spectrometry	≤0.1%	Complies	Complies	Complies	Complies	Complies	Complies
Sterility	Sterility Test (Eur.Ph.)	Sterile	Sterile	Sterile	Sterile	Sterile	Sterile	Sterile
Bacterial Endotoxins	Eur.Ph.	≤175 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V