Component | Amount | Function | Quality standard |
68Ga-PSMA-11 | 18.5–185 MBq/mL (0.5–5 mCi/mL) | Drug substance | In-house |
PSMA-11 | 5 μg | Drug substance precursor | GMP |
HEPES* | 1.5 mL (1.5 M) | Processing aid | PharmaGrade |
Hydrochloric acid*1 | 5 mL (0.1 M) | Processing aid | GMP |
Sodium chloride 0.9% injection | 10 mL | Tonicity | USP |
Ethanol | 1 mL | Eluent | USP |
Water for injection USP | 1 mL | Eluent | USP |
↵* HEPES and hydrochloric acid are completely removed during processing and are not present in final formulation. GMP = good manufacturing practice; HEPES = 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid.