Table 2 Results of quality test for [211At]NaAt solution
From: Production of [211At]NaAt solution under GMP compliance for investigator-initiated clinical trial
Test items | Acceptance criteria | Lot No.1 | Lot No.2 | Lot No.3 |
|---|---|---|---|---|
Radioactivity (MBq) | - | 81.6 | 72.0 | 82.9 |
Appearance | Clear and colorless to light yellow | Clear and colorless | Clear and colorless | Clear and colorless |
Particle | None | None | None | None |
Identity of [211At]NaAt (min) | RT of NaI + 2.5–+ 3.5 | + 3.2 | + 3.3 | + 3.3 |
Half-life (hr) | 6.8–7.6 | 7.3 | 7.3 | 7.2 |
Concentration of radioactivity (at EOS) (MBq/mL) | ≧ 4.0 | 5.8 | 5.3 | 5.9 |
Radionuclidic identity | Exhibits the peaks at 76.9 keV, 79.3 keV and 687.0 keV | Exhibits the peaks at 76.9 keV, 79.3 keV and 687.0 keV | Exhibits the peaks at 76.9 keV, 79.3 keV and 687.0 keV | Exhibits the peaks at 76.9 keV, 79.3 keV and 687.0 keV |
Radiochemical purity (at EOS) (%) | ≧ 85 | 98 | 96 | 97 |
Contamination from other radionuclide | Exhibits no peak except comes from 211At | Exhibits no peak except comes from 211At | Exhibits no peak except comes from 211At | Exhibits no peak except comes from 211At |
pH | 7.0–9.0 | 8.6 | 8.5 | 7.9 |
Sterility | Sterile | Sterile | Sterile | Sterile |
Endotoxin (EU/mL) | < 10.0 | < 2.0 | < 2.0 | < 2.0 |
Concentration of ascorbic acid (mg/mL) | ≧ 6 | 10 | 10 | 9 |
Filter integrity test (kPa) | ≧ 345 | 411 | 424 | 419 |