Futureproofing [18F]Fludeoxyglucose manufacture at an Academic Medical Center

EJNMMI Radiopharmacy and Chemistry

Table 3 Comparison of FDG with Reference Listed Drug after each update

	RLD Requirement	Historical^a	Phase 1^a	Phase 2^a
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

^aHistorical: TRACERLab/Ag targets; Ph 1: FASTLab/Ag targets; Ph 2: FASTLab/Nb targets