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, 1 M* | 1.3 mL | Buffering agent | Pharma grade |
Nitric acid, 0.1 M1 | 4 mL | 68Ga purification | Trace-metal basis |
Hydrochloric acid, 1.75 M* | 4 mL | 68Ga purification | Ultrapure |
Sodium chloride, 2 M1 | 4 mL | 68Ga purification | Trace metal basis |
Ethanol, 60% | 1 mL | Product eluent | USP grade |
Ultra-high purity water | 50 mL | Solution preparation | Pharma grade |
Water for injection | 100 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.