Quality control data	Validation run 1	Validation run 2	Validation run 3
[requirement for “Pass”]
Appearance	Pass	Pass	Pass
[clear, colorless, free of particulate matter]
Radioactivity concentration at EOS	213 MBq/mL	210 MBq/mL	180 MBq/mL
[≤ 740 MBq/mL @ EOS]
pH	6	5.8	6
[5.0 – 8.0]
Half-life	115 min	108 min	112 min
[105 – 115 min]
Radiochemical purity	99%	99%	99%
[> 95%]
Radiochemical identity by relative retention time (RRT)	1.01	1.01	1.01
[1.00 < RRT < 1.10]
Molar activity	314 GBq/µmol	>370 GBq/µmol	>370 GBq/µmol
[≥ 3.7 GBq/µmol]
Total carrier mass in final product	3.1 µg	<1 µg	<1 µg
[≤ 50 µg/dose]
Total impurity mass in final product	ND	ND	ND
[≤ 1 µg / dose]
Maximum allowable injection volume based on total carrier mass ≤ 50 µg/dose AND total impurity mass ≤ 1 µg/dose	Whole batch	Whole batch	Whole batch
Residual EtOH content by GC	8.90%	9.50%	9.60%
[≤ 10%]
Residual EtOAc content by GC	<1 ppm	<1 ppm	<1 ppm
[≤ 5000 ppm]
Residual MeCN content by GC	<1 ppm	<1 ppm	<1 ppm
[≤ 410 ppm]
Residual K222 by color spot test	Pass	Pass	Pass
[< 50 µg/mL]
Filter membrane integrity test	Pass	Pass	Pass
[bubble point ≥ 50 psi]
Bacterial endotoxins	Pass	Pass	Pass
[≤ 175 EU/batch]
Radionuclidic purity by gamma spectroscopy	Pass	Pass	Pass
[>99.5%]
Sterility	Pass	Pass	Pass
[meet USP <71> requirements]