Table 3:

Results from Testing of the First Production Pathway

Release Criteria	Specification	Test 1A	Test 2A	Test 3A
Appearance	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates
Filter Integrity	> 40 psi	51 psi	52 psi	52 psi
pH	4 – 8	4.5	4.5	4.5
Radiochemical Purity	≥ 90%	> 99.9 %	98.4 %	99.2 %
Molar Activity	≥ 18.5 GBq/μmol (≥ 500 Ci/mmol)	380 GBq/μmol (10282 Ci/mmol)	415 GBq/μmol (11238 Ci/mmol)	422 GBq/μmol (11403 Ci/mmol)
Residual Solvent	≤ 5000 ppm MEK	0 ppm	7.58 ppm	6.84 ppm
Formulation	NMT 10% EtOH	7.8 %	7.8 %	7.2 %
Total Chemical Impurities	NMT 50 μg/dose	0.083 μg/mL	0.240 μg/mL	0.202 μg/mL
Activity in Final Vial		3.66 GBq (99.0 mCi)	4.55 GBq (122.9 mCi)	3.65 GBq (98.7 mCi)
Concentration		295 MBq/mL (7.97 mCi/mL)	385 MBq/mL (10.4 mCi/mL)	296 MBq/mL (8.0 mCi/mL)