Table 1.

Summary of quality specifications and test methods for [¹⁸F]FPEB, and quality control analysis results from three consecutive production batches

Test #	Test parameters	Specifications	Test Methods	Test Results*
				Batch #1	Batch #2	Batch #3
1	Dose Vial Integrity	Vial & septum intact	Visual inspection	Intact	Intact	Intact
2	Product Appearance	Clear, no presence of particulate matters	Visual inspection	Clear, no presence of particulate matters	Clear, no presence of particulate matters	Clear, no presence of particulate matters
3	Product pH	4.5 – 8.5	pH paper	6.0	6.0	6.5
4	Radiochemical Purity	≥ 90%	HPLC	99.3%	99.5%	98.7%
5	Chemical Purity	≥ 90%	HPLC	98.7%	97.9%	100%
6	Radiochemical Identity	Radioactive peak within ±10% of UV peak retention time	HPLC	2.2 % difference	1.5 % difference	1.4 % difference
7	Specific Activity	-	Calculation against a standard mass curve	5.10 mCi/nmol	3.73 mCi/nmol	14.6 mCi/nmol
8	Radionuclide Identity	t½ = 98.8 – 120.8 min	Counting in a dose calibrator	t½ = 109.9 min	t½ = 111.7 min	t½ = 117.5 min
9	Membrane Integrity	Bubble point ≥ 50 psi for Millipore GV filter	Bubble point test	≥ 50 psi	≥ 50 psi	≥ 50 psi
10	Endotoxin Level	≤ 17.5 EU/mL in a 10 mL dose volume	Charles River Endo- safe PTS	≤ 5 EU/mL	≤ 5 EU/mL	≤ 5 EU/mL
11	Volatile Organic Impurities	MeCN < 0.41 mg/mL DMSO < 5.0 mg/mL	GC	MeCN < 0.41 mg/mL DMSO < 5.0 mg/mL	MeCN < 0.41 mg/mL DMSO < 5.0 mg/mL	MeCN < 0.41 mg/mL DMSO < 5.0 mg/mL
12	Residual Kryptofix K222	< 0.05 mg/mL	TLC	< 0.05 mg/mL	< 0.05 mg/mL	< 0.05 mg/mL
13	Sterility Test	Sterile, no growth at 14 days of incubation in media	Incubation with test media for 14 days	No evidence of growth at 14-day incubation	No evidence of growth at 14-day incubation	No evidence of growth at 14-day incubation
Yield (mCi) at EOS (Decay-uncorrected) -				70.2 mCi	42.9 mCi	108.1 mCi
Yield (%) at EOS (Decay-uncorrected) -				2.8 %	1.8 %	3.8 %

^*Quality control tests were conducted with an aliquot of [¹⁸F]FPEB product solution taken from the dose vial at the end of synthesis, and according to specifications and test methods defined in the approved Drug Master File (DMF) of [¹⁸F]FPEB for Injection at Yale University School of Medicine.