TABLE 3

Batch Formula for UCSF Final Product (Cyclotron-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, 1 M*1.3 mLBuffering agentPharma grade
Nitric acid, 0.1 M14 mL68Ga purificationTrace-metal basis
Hydrochloric acid, 1.75 M*4 mL68Ga purificationUltrapure
Sodium chloride, 2 M14 mL68Ga purificationTrace metal basis
Ethanol, 60%1 mLProduct eluentUSP grade
Ultra-high purity water50 mLSolution preparationPharma grade
Water for injection100 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.