From: Automated GMP compliant production of [18F]AlF-NOTA-octreotide
Test Parameters | Acceptance Criteria | Test Methods |
---|---|---|
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 | Â | Radio-HPLC |
 a. [18F]AlF-NOTA-octreotide | ≥91% of total radioactivity |  |
 b. Sum [18F]F− and [18F]AlF | ≤5% |  |
Chemical purity | Â | 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 injecteda | ≤50 μg per injected volume |  |
 b. Amount (μg) of sum of unidentified chemical impurities in total volume to be injecteda | ≤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 | Â | GC |
 a. EtOH | ≤10%v/v |  |
 b. Residual solvent | Conforms Ph Eur. |  |
8. Total Radioactivity | 200–12,110 MBq/batchc | Dose calibrator |
9. Radionuclide identity- approximate half-life (T1/2) | T1/2 = 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 °Cb | Current Ph. Eur. < 2.6.1> |
13. Bacterial Endotoxins | ≤175 IU per injected volume | LAL-test Current Ph. Eur. < 2.6.14> |