Table 6 [18F]AlF-NOTA-octreotide validation runs batch analysis
From: Automated GMP compliant production of [18F]AlF-NOTA-octreotide
Test | Specification | Batch A | Batch B | Batch C |
|---|---|---|---|---|
1. Identification | Stereoisomer 1 has a relative retention of 1.3 (±10%) with reference to NOTA-octreotide | Conforms | Conforms | Conforms |
Relative retention stereoisomer 1: 1.3 | Relative retention stereoisomer 1: 1.3 | Relative retention stereoisomer 1: 1.4 | ||
Stereoisomer 2 has a relative retention of 1.5 (±10%) with reference to NOTA-octreotide | ||||
Relative retention stereoisomer 2: 1.5 | Relative retention stereoisomer 2: 1.5 | Relative retention stereoisomer 2: 1.5 | ||
2. Radiochemical purity | ||||
 a. [18F]AlF-NOTA-octreotide | ≥91% of total radioactivity | 96.5% | 96.3% | 96.0% |
 b. [18F]F− or [18F]AlF | ≤5% | 0.4% | 1% | 0.5% |
3. Chemical purity | ||||
 a. Amount (μg) of AlF-NOTA-octreotide, NOTA-octreotide and metal complexes of NOTA-octreotide in total volume to be injectedc | ≤50 μg per injected volumea | 162 μg/18.6 ml | 94 μg/18.9 ml | 63 μg/18.2 ml |
 b. Amount (μg) of sum of unidentified chemical impurities in total volume to be injectedc | ≤50 μg per injected volume | <LOD | <LOD | <LOD |
4. pH | pH of the finished product is 4.5–8.5 | 7 | 7 | 7 |
5. Integrity of the sterile filter membrane | Bubble point ≥3.4 bar | 3.6 bar | 3.8 bar | bar |
6. Appearance | Colorless and free particle matter | Conforms | Conforms | Conforms |
7. Residual solvent | ||||
 a. EtOH | 5–10% v/v | 10% v/v | 10% v/v | 9% v/v |
 b. Residual solvents | Conforms Ph Eur. | Conforms | Conforms | Conforms |
8. Total Radioactivity | 200–12,110 MBq/batch | 9542 MBq | 12,110 MBq | 10,660 MBq |
9. Radionuclide identity- approximate half-life (T1/2) | T1/2 = 105–115 min | 106.2 min | 107.8 min | 111.6 min |
10. Radionuclide identity – gamma spectrometry | Gamma energy is 501–521 keV | 518 keV | 516 keV | 516 keV |
11. Sterility | No growth after 14 days incubation at 37 °C conform Ph. Eur. | Conforms | Conforms | Conforms |
12. Bacterial Endotoxins | ≤175 IU per injected volume | Conforms | Conforms | Conforms |