GMP-compliant 68Ga radiolabelling in a conventional small-scale radiopharmacy: a feasible approach for routine clinical use

EJNMMI Research

Table 1 Selected parameters from the Ph. Eur. monograph on ⁶⁸ Ga-chloride and how they are controlled

Parameter	Specification	Method
Iron	Maximum 10 μg/GBq	Quality by design: risk-based approach eliminated need for routine test
Zinc	Maximum 10 μg/GBq	Quality by design: risk-based approach eliminated need for routine test
Bacterial endotoxins	Less than 175 IU/V to be used for the preparation of a single patient dose	Quality by design: risk-based approach eliminated need for routine test
Impurity A	≤0.001%	Ionization chamber: performed at time of acceptance of generator