Batch Formula for UCLA Final Product

ComponentAmountFunctionQuality standard
68Ga-PSMA-1118.5–185 MBq/mL (0.5–5 mCi/mL)Drug substanceIn-house
PSMA-115 μgDrug substance precursorGMP
HEPES*1.5 mL (1.5 M)Processing aidPharmaGrade
Hydrochloric acid*15 mL (0.1 M)Processing aidGMP
Sodium chloride 0.9% injection10 mLTonicityUSP
Ethanol1 mLEluentUSP
Water for injection USP1 mLEluentUSP
  • * 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.