From: Development and implementation of ISAR, a new synthesis platform for radiopharmaceutical production
QC Tests | Specifications | Lot 1 | Lot 2 | Lot 3 |
---|---|---|---|---|
Visual Inspection | Clear, colorless, no ppt | Pass | Pass | Pass |
Radiochemical-ID | RRTa: 0.9–1.1 | 0.94 | 0.95 | 0.97 |
Radionuclidic-ID | t1/2: 9.5–10.5 min | 9.99 | 9.97 | 10.00 |
Filter integrity | Bubble point ≥50 psi | 53 | 61 | 62 |
Endotoxins | ≤43.75 EU/mL | < 2.00 | < 2.00 | < 2.00 |
Sterility | No microbial growth | Pass | Pass | Pass |
pH value | 4.5–7.5 | 5.0 | 5.0 | 5.0 |
RCP | ≥90% | > 99.9% | > 99.9% | > 99.9% |