Table 1:

QC data for [¹⁸F]NML validation runs

QC Test	Specifications	Michigan (n = 4)	Positronpharma (n = 5)
Radioactivity Conc.	≥370 MBq/batch	2.8 ± 0.7 GBq	2.4 ± 1.8 GBq
NML Conc.	N/A	3.3 ± 2. 7 μg/mL	0.9 ± 0.8 μg/mL
Molar activity	≥14.1 GBq/μmolb	37 ± 15 GBq/μmol	233 ± 324 GBq/μmol
Mass limit	≤ 10 μg/injection	2.80±2.73 μg	1.06±0.61 μg
Radiochemical Purity	>95%	100 ± 0	97.7 ± 0.8%
Identity	RRTa = 0.9–1.1	1.0 ± 0.0	1.0 ± 0.0
Visual Inspection	Clear, colorless, no ppt	Pass	Pass
pH	4.5–7.5	5.0 ± 0.0	5.0 ± 0.0
Radionuclidic Identity	t1/2 = 105–115 min	109 ± 2 min	110 ± 2
Residual crypt-222	≤50 μg/mL	< 50 μg/mL	< 50 μg/mL
Residual DMSO	≤5000 ppm	19 ± 13 ppm	11.4 ± 16.7 ppm
Residual MeCN	≤410 ppm	24 ± 3 ppm	0.92 ± 1.41 ppm
Filter membrane integrity	≥44 psi	49 ± 2 psi	>50 psi
Bacterial endotoxins	≤ 2.00 EUc/mL	<2.00 EUb/mL	<1.75 EUc/mL
Sterility	No microbial growth	Pass	Pass

^aRelative retention time (RRT) = [HPLC retention time of [¹⁸F]NML / HPLC retention time of NML reference standard];

^bAssuming based on worst case scenario of 10 μg in a 370 MBq injection;

^cEU = endotoxin units.