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Table 3 Selected parameters from the Ph. Eur. monograph on 68 Ga-edotreotide 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
Identity DOTA-NOC DOTA-NOC Acceptance of raw material
Content: 68Ga 90 – 110% of the declared 68Ga radioactivity Ionization chambera
Content: DOTA-NOC Maximum 50 μg Quality by design: pre-filled vials with amount needed together with double check in batch recorda
Appearance Clear, colourless solution Visual inspectiona
pH 4.0 to 8.0 pH indicator stripa
Ethanol Maximum 10% (V/V)/maximum 2.5 g per dose Quality by design: risk-based approach eliminated need for routine test
Sterility Sterile; bubble point >3,450 mbar Validation of aseptic process together with filter integrity testa
Bacterial endotoxins Less than 175 IU per dose Quality by design: risk-based approach eliminated need for routine test
Impurity A ≤3% ITLCa
Impurity B ≤2% Validated ITLC method to replace HPLCa
Impurity C ≤0.001% Ionization chamber; assessed at time of acceptance of generator
  1. aParameter with corresponding method that is performed after every preparation of 68Ga-DOTA-NOC.