Table 1.
Release and Stability Test Data for Three Qualification Batches of [18F]FNDP Injection Manufactured at the JHU PET Center
| [18F]FNDP Lot Number Date/Time of Manufacture | FNDP-17012301 23 Jan 17; 10:20:41 | FNDP-17012501 25 Jan 17; 09:01:00 | FNDP-17020601 6 Feb 17; 09:16:00 | |
|---|---|---|---|---|
| Test | Specification | |||
| Initial Appearance | Clear, colorless solution, no visible particulate matter | Conforms | Conforms | Conforms |
| Appearance 360 minutes after EOS | Clear, colorless solution, no visible particulate matter | Conforms | Conforms | Conforms |
| Initial Radiochemical Purity, % (t = 0 minutes) |
≥ 95% |
100% | 100% | 100% |
| Expiry Radiochemical Purity, % (t =240 minutes) |
≥ 95% |
100% | 98.3% | 100% |
| pH, Initial | 4.5 – 8.5 | 5.0 | 5.2 | 5.0 |
| pH, Expiry | 4.5 – 8.5 | 5.2 | 5.0 | 5.0 |
| Chemical Purity |
FNDP Precursor ≤ 0.5 µg/mL All others ≤ 0.5 µg/mL |
FNDP: 0.03 µg/mL Precursor: 0.00 µg/mL All others: 0.03 µg/Ml |
FNDP: 0.04 µg/mL Precursor: 0.00 µg/mL All others: 0.02 µg/mL |
FNDP: 0.07 µg/mL Precursor: 0.00 µg/mL All others: 0.11 µg/mL |
| Yield | ≥ 30 mCi [18F]FNDP (referenced to assay recorded at end-of-filtration) |
142 mCi | 235 mCi | 238.5 mCi |
| Specific Activity | ≥ 1,500 mCi/µmole of [18F]FNDP (referenced to end of filtration) |
105641 mCi/µmole | 133519 mCi/µmole | 74887 mCi/µmole |
| Identity (HPLC) |
HPLC Retention Time Matches Reference Standard | Match | Match | Match |
| Radionuclidic Purity | T½ Calc = 105 – 115 min | 107.45 min | 111.20 min | 109.03 min |
| Bubble-Point | ≥ 13 psi | 16 psi | 17 psi | 17 psi |
| Kryptofix Analysis | ≤ 50 µg/mL | Conforms | Conforms | Conforms |
| Residual Solvent Analysis | Ethanol ≤ 10% Acetonitrile ≤ 273 ppm DMSO ≤ 3333 ppm Triethylamine ≤ 280 ppm |
EtOH: 7.4% CH3CN: 0 DMSO: 330 TEA: 0 |
EtOH: 7.4% CH3CN: 0 DMSO: 354 TEA: 0 |
EtOH: 7.5% CH3CN: 9.3 DMSO: 330 TEA: 0 |
| Bacterial Endotoxin | ≤11 Endotoxin Unit per mL | <5 EU/ml | <5 EU/ml | <5 EU/ml |