Table 3 Tests parameters, acceptance criteria and test methods applied for [¹⁸F]AlF-NOTA-octreotide

1. Identification

Stereoisomer 1 has a relative retention of 1.3 (±10%) with reference to NOTA-octreotide

HPLC with radiodetector and UV/VIS detector

Stereoisomer 2 has a relative retention of 1.5 (±10%) with reference to NOTA-octreotide

2. Radiochemical purity

Radio-HPLC

 a. [¹⁸F]AlF-NOTA-octreotide

≥91% of total radioactivity

 b. Sum [¹⁸F]F⁻ and [¹⁸F]AlF

≤5%

Chemical purity

HPLC with UV/VIS detector

 a. Amount (μg) of AlF-NOTA-octreotide, NOTA-octreotide and metal complexes of NOTA-octreotide in total volume to be injected^a

≤50 μg per injected volume

 b. Amount (μg) of sum of unidentified chemical impurities in total volume to be injected^a

≤50 μg per injected volume

4. pH

pH of the finished product is 4.5–8.5

pH strip

5. Integrity of the sterile filter membrane

Bubble point ≥3.4 bar

Bubble point determination

6. Appearance

Colourless and particle-free

Visual inspection

7. Residual solvent

GC

 a. EtOH

≤10%v/v

 b. Residual solvent

Conforms Ph Eur.

8. Total Radioactivity

200–12,110 MBq/batch^c

Dose calibrator

9. Radionuclide identity- approximate half-life (T_1/2)

T_1/2 = 105–115 min

Two time point radioactivity measurement in dose calibrator

10. Radionuclide identity – gamma spectrometry

Gamma energy is 501–521 keV

Gamma spectrum on NaI (Tl) spectrometer

11. Radionuclide purity

≤0.1% of the activity of fluorine-18

Gamma spectrum on NaI (Tl) spectrometer

12. Sterility

No growth after 14 days incubation at 37 °C^b

Current Ph. Eur. < 2.6.1>

13. Bacterial Endotoxins

≤175 IU per injected volume

LAL-test

Current Ph. Eur. < 2.6.14>