Acceptance Criteria for Batch Release
| Criteria | Values or range of acceptance |
|---|---|
| Appearance | Colorless, clear, free from particulate matter |
| Assay | 0.4–2.8 MBq (11–76 μCi)/mL |
| Specific activity | 0.67–4.67 MBq (18–126 μCi)/mg |
| pH | 5–8 |
| Radionuclide identity | 218 and 440 keV |
| Radiochemical purity | 225Ac-DOTA-J591 > 95% |
| Test for endotoxins | <35 endotoxin units/mL |
| Bubble test | Pt > Pm, where Pm = ψ |
| Sterility test | Test started within 24 h |
Pt = pressure at which bubbles appear; Pm = minimum acceptable bubble point pressure; ψ = pound-force per square inch.