Table 4:

Results from Testing of the Second Production Pathway

Release Criteria	Specification	Test 1B	Test 2B	Test 3B
Appearance	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates	Clear, Colorless, No Particulates
Filter Integrity	> 40 psi	48 psi	47 psi	49 psi
pH	4 – 8	4.5	4.0	4.0
Radiochemical Purity	≥ 90%	99.6 %	99.5 %	98.4 %
Molar Activity	≥ 18.5 GBq/μmol (≥ 500 Ci/mmol)	1164 GBq/μmol (31450 Ci/mmol)	747 GBq/μmol (20181 Ci/mmol)	1166 GBq/μmol (31510 Ci/mmol)
Residual Solvent	≤ 5000 ppm MEK	16 ppm	16 ppm	16 ppm
Formulation	NMT 10% EtOH	6.8 %	6.7 %	6.8 %
Total Chemical Impurities	NMT 50 μg/dose	0.264 μg/mL	0.354 μg/mL	0.268 μg/mL
Activity in Final Vial		3.85 GBq (104 mCi)	3.7 GBq (100 mCi)	2.68 GBq (72.5 mCi)
Concentration		294 MBq/mL (7.94 mCi/mL)	310 MBq/mL (8.39 mCi/mL)	216 MBq/mL (5.83 mCi/mL)