Table 1|.

[¹⁸F]FDOPA Process Verification Batch QC Data using the One-pot Method^a

QC Test	Specifications	Result (n = 3)b
Radioactivity Conc.	≥0.37 Gbq/batch	3.85 ± 0.59 GBq
F-DOPA Conc.	≤5μg/mL	0.69 ± 0.47 μg/mL
H-DOPA	≤50μg/mL	Not detected
HO-DOPA	≤50μg/mL	Not detected
Molar activity	≥ 18.5 TBq/mmol	141 ± 77 TBq/mmol
Radiochemical Purity	>90%	99.7 ± 0.3%
Radiochemical Purity 2 h post-EOS	>90%	99.1 ± 1.2%
Radiochemical Purity 4 h post-EOS	>90%	96.5 ± 1.0%
Radiochemical Identity	RRTc = 0.9–1.1	1.02 ± 0.002
Enantiomeric Purity	≥ 95% L-FDOPA	>99%
Visual Inspection	Clear, colorless, no ppt	Pass
pH	4.5–7.5	5.5 ± 0
Radionuclidic Identity	T1/2 = 105–115 min	112 ± 2 min
Residual TBA+	≤260 μg/mL by Dragendorff reagent	< 260 μg/mL
Residual DMF	≤880 ppm	106 ± 56 ppm
Residual MeCN	≤410 ppm	179 ± 78 ppm
Residual Cu	≤34 ppm	0.11 ± 0.02 ppm
Filter membrane integrity	≥50 psi	56 ± 1 psi
Bacterial endotoxins	≤ 2.00 EUd/mL	<2.00 EUd/mL
Sterility	No microbial growth	Pass

^aSome data in this Table is reproduced from Ref. ⁴³ with permission from The Royal Society of Chemistry.

^bGrouped data are reported as mean ± standard deviation

^cRelative retention time (RRT) = [HPLC retention time of [¹⁸F]FDOPA / HPLC retention time of FDOPA reference standard]

^dEU = endotoxin units.