TABLE 5. USP <823> Tested Batch Results.
Results from four ELXIYS production runs tested according to United States Pharmacopeial Convention, Chapter 823.
| Test | Specification | Run #2 | Run #3 | Run #4 | Run #5 | Mean ± SD |
|---|---|---|---|---|---|---|
| Radiochemical Yield | EOS Yield | 0.98 GBq (26.4 mCi) | 3.44 GBq (92.9 mCi) | 2.32 GBq (62.7 mCi) | 4.74 GBq (128.1 mCi) | 2.87 ± 1.39 GBq (77.5 ± 37.5 mCi) |
| Strength | Radioactivity concentration at EOS | 97 MBq/mL | 343 MBq/mL | 232 MBq/mL | 474 MBq/mL | 287 ± 139 MBq/mL (7.8 ± 3.8 mCi/mL) |
| Visual Solution Inspection | Clear, colorless, and free of particulate matter | Pass | Pass | Pass | Pass | Pass |
| Vial Integrity | Intact | Pass | Pass | Pass | Pass | Pass |
| Membrane Filer Integrity | Bubble point > 13 psi | 21 | 21 | 20 | 20 | 20.5 ± 0.5 psi |
| pH | 4–8 | 7.2 | 7.2 | 7 | 7 | 7.1 |
| Radiochemical Identity | Retention time within ±10 % of THK-5351 standard | 1.5 % | 1.9 % | 0.8 % | 1.1 % | 1.3 ± 0.4 % |
| Radiochemical Purity | [18F]THK-5351 peak > 90% of the sum of all radioactivity peaks | 100 % | 99.9 % | 100 % | 99.8 % | 99.9 ± 0.1 % |
| Chemical Purity | Non-THK-5351 mass peaks < 3.7 μg in 10 mL (360nm abs) | < 0.2 μg (none detected) | < 0.2 μg (none detected) | < 0.2 μg (none detected) | < 0.2 μg (none detected) | < 0.2 μg (none detected) |
| Molar Activity | > 18.5 GBq/μmol | 144 GBq/μmol | 317 GBq/μmol | 210 GBq/μmol | 322 GBq/μmol | 248 ± 75 GBq/μmol |
| Residual Solvents | Acetonitrile <0.41 mg/mL | Pass | Pass | Pass | Pass | Pass |
| Radionuclidic Identity | Half-life 105–115 minutes | 108.6 min | 109.0 | 108.4 | 109.5 | 108.9 ± 0.4 min |
| Radionuclidic Purity | >99 % of total counts at 511 keV, 1022 keV or Compton scatter | 100 % | 100 % | 100 % | 100 % | 100 ± 0 % |
| Bacterial Endotoxin Testing | <17.5 EU/mL | < 2 EU/mL | < 2 EU/mL | < 2 EU/mL | < 2 EU/mL | < 2 EU/mL |
| Sterility | No growth at 14 days post- inoculation | No Growth | No Growth | No Growth | No Growth | No Growth |
| Residual Kryptofix 2.2.2 | < 50 μg/mL (spot visibility less than standard) | No Spot, Pass | No Spot, Pass | No Spot, Pass | No Spot, Pass | No Spot, Pass |