Table 1 Test items and acceptance criteria of quality tests for [211At]NaAt solution
From: Production of [211At]NaAt solution under GMP compliance for investigator-initiated clinical trial
Test items | Acceptance criteria | Test method |
|---|---|---|
Appearance | Clear and colorless to light yellow | Visual inspection |
Particle | None | Visual inspection |
Identity of [211At]NaAt | RT of NaI + 2.5–+ 3.5 min | HPLC (Radioactivity and UV/VIS detector) |
Half-life | 6.8–7.6 h | Dose-calibrator |
Concentration of radioactivity (at EOS) | ≧ 4.0 MBq/mL | Dose-calibrator |
Radionuclidic identity | Exhibits the peaks at 76.9 keV, 79.3 keV and 687.0 keV | γ-ray spectrometry with Ge semiconductor detector |
Radiochemical purity (at EOS) | ≧ 85% | HPLC (Radioactivity detector) |
Contamination from other radionuclide | Exhibits no peak except comes from 211At | γ-ray spectrometry with Ge semiconductor detector |
pH | 7.0–9.0 | glass electrode method |
Sterility | Sterile | Direct inoculation |
Endotoxin | < 10.0 EU/mL | Turbidimetric technique |
Concentration of ascorbic acid | ≧ 6 mg/mL | Reflection photometer |
Filter integrity test | ≧ 345 kPa | Bubble point method |