From: An updated radiosynthesis of [18F]AV1451 for tau PET imaging
QC Test | Release Criteria | Batch 1 | Batch 2 | Batch 3 | Batch 4 |
---|---|---|---|---|---|
Visual inspection | Clear, colorless, free of particulates | Pass | Pass | Pass | Pass |
pH | 4.5-7.5 | 5.0 | 5.0 | 5.0 | 5.0 |
Radiochemical Yield (mCi) | >10 mCi | 170 | 140 | 231 | 266 |
Radioactivity Conc. | >10 mCi/10 mL | 34 | 28 | 46 | 53 |
AV1451 Conc. | ≤5.0 μg/mL | 2.5 | 2.0 | 3.5 | 2.5 |
SA (Ci/mmol) | N/A | 1,789 | 3,228 | 2,788 | 2,278 |
RCP (%) | >90% | 98 | 97 | 98 | 100 |
Radiochemical Identity | RRTa =0.9-1.1 | 1.0 | 1.0 | 1.0 | 1.0 |
Radionuclidic Identity | t1/2 = 105-115 min | 107 | 107 | 110 | 109 |
Residual K2.2.2 | ≤50 μg/mL | ≤50 | ≤50 | ≤50 | ≤50 |
Filter Integrity | >44 psi | 51 | 50 | 50 | 51 |
Bacterial Endotoxins | <17.5 EU/mLb | <2.00 | <2.00 | <2.00 | <2.00 |
Sterility | Sterile | Sterile | Sterile | Sterile | Sterile |