Table 3 Selected parameters from the Ph. Eur. monograph on ⁶⁸ Ga-edotreotide and how they are controlled

Identity DOTA-NOC

DOTA-NOC

Acceptance of raw material

Content: ⁶⁸Ga

90 – 110% of the declared ⁶⁸Ga radioactivity

Ionization chamber^a

Content: DOTA-NOC

Maximum 50 μg

Quality by design: pre-filled vials with amount needed together with double check in batch record^a

Appearance

Clear, colourless solution

Visual inspection^a

pH

4.0 to 8.0

pH indicator strip^a

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 test^a

Bacterial endotoxins

Less than 175 IU per dose

Quality by design: risk-based approach eliminated need for routine test

Impurity A

≤3%

ITLC^a

Impurity B

≤2%

Validated ITLC method to replace HPLC^a

Impurity C

≤0.001%

Ionization chamber; assessed at time of acceptance of generator