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

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

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