TABLE 4.

Batch Formula for UCSF Final Product (Generator-Based Production)

Component	Amount	Function	Quality standard
PSMA-11	5 μg	Precursor	GMP grade
68Ga-PSMA-11	18.5–185 MBq/mL (0.5–5 mCi/mL)	Drug substance	In-house
Sodium acetate, 0.5 M*	0.1 mL	Buffering agent	Pharma grade
Hydrochloric acid, 0.1 M*	5 mL	Generator eluent	GMP grade
Ethanol, 60%	1 mL	Product eluent	USP grade
Ultra-high purity water	10 mL	Solution preparation	Pharma grade
Water for injection	4 mL	Solution preparation	USP grade
Sodium chloride, 0.9%	5–10 mL	Isotonicity	USP grade

^*Completely removed during processing and are not present in final formulation. GMP = good manufacturing practice.