Table 2. Radiopharmaceutical analyses shows the formulation meets USP specifications.

Analysis	Specification
Bubble point filter membrane integrity	>= 50 psi
Visual appearance	Clear colorless solution, no visible particulate matter.
pH testing	6.8 – 7.4
Strength (mCi/mL)	1 – 5 mCi in 10 mL
Radiochemical purity	iTLC >= 95%
Bacterial endotoxin	<= 175 EU/V
Specific activity	>= 0.2 mCi/mg
Sterility	Sterile (no visible growth)
Environmental profile	<= 1 cfu/plate (contact)
	<= 3 cfu/plate (settling)
	<= 3 cfu/plate (finger)
Immunoreactivity	>= 73%