From: Futureproofing [18F]Fludeoxyglucose manufacture at an Academic Medical Center
RLD Requirement | Historicala | Phase 1a | Phase 2a | |
---|---|---|---|---|
Conditions of Use | Neurology, oncology, cardiology | Neurology, oncology, cardiology | Neurology, oncology, cardiology | Neurology, oncology, cardiology |
Active Ingredient | FDG | FDG | FDG | FDG |
Route of Administration | Intravenous | Intravenous | Intravenous | Intravenous |
Dosage Form | Injection | Injection | Injection | Injection |
Strength | 20–300 mCi/mL (@ EOS) | 24 | 29 | 33 |
Specific activity | No-carrier-added (NCA) | NCA | NCA | NCA |
Inactive Ingredients | 4.5 mg/mL NaCl in citrate buffer | 4.58 mg/mL | 4.55 mg/mL | 4.55 mg/mL |
Osmolality | Isotonic | Isotonic | Isotonic | Isotonic |