TABLE 4

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

ComponentAmountFunctionQuality standard
PSMA-115 μgPrecursorGMP grade
68Ga-PSMA-1118.5–185 MBq/mL (0.5–5 mCi/mL)Drug substanceIn-house
Sodium acetate, 0.5 M*0.1 mLBuffering agentPharma grade
Hydrochloric acid, 0.1 M*5 mLGenerator eluentGMP grade
Ethanol, 60%1 mLProduct eluentUSP grade
Ultra-high purity water10 mLSolution preparationPharma grade
Water for injection4 mLSolution preparationUSP grade
Sodium chloride, 0.9%5–10 mLIsotonicityUSP grade
  • * Completely removed during processing and are not present in final formulation. GMP = good manufacturing practice.