Table 2.

Quality control data on [¹⁸F]F^- batches from different suppliers.

Parameter	Method	Acceptance Criteria	Batch 14/02/19 Supp. 1	Batch 15/03/19 Supp. 1	Batch 12/04/19 Supp. 1	Batch 09/07/20 Supp. 2	Batch 30/07/20 Supp. 2	Batch 06/08/20 Supp. 2
[18F]F- Activity	Dose calibrator	12,690–30,600 MBq	12,691 MBq	19,721 MBq	30,599 MBq	16,562MBq	20,139 MBq	21,281 MBq
Radioactive Concentration	Dose calibrator	2.7–21.8 GBq/mL	9.1 GBq/mL	13.1 GBq/mL	21.8 GBq/mL	2.76 GBq/mL	3.36 GBq/mL	3.55 GBq/mL
Volume		1.4–6	1.4 mL	1.5 mL	1.4 mL	6 mL	6 mL	6 mL
Appearance	Visual test	Clear and colorless solution	Complies	Complies	Complies	Complies	Complies	Complies
Identification	γ Spectrometry	Peaks at 511 and 1022 Kev	Complies	Complies	Complies	Complies	Complies	Complies
	Half life	105–115 min	Complies	Complies	Complies	Complies	Complies	Complies
Identification	HPLC	TR [18F]F- test ± 0.5 min TR [18F]F- reference standard	Complies	Complies	Complies	Complies	Complies	Complies
Radiochemical Purity	HPLC	[18F]F- ≥ 98.5%	99.6%	99.2%	99.5%	100%	100%	100%
pH	pH strips	8–14	9	9	9	9	9	9
Radionuclidic Purity	γ Spectrometry	Impurities < 0.1%	Complies	Complies	Complies	Complies	Complies	Complies
Bacterial Endotoxins	Eur.Ph.	≤20 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V	≤10 EU/V