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Table 1 QC Data for Process Verification Batches of [18F]AV1451

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
  1. aRRT = Relative retention time (tR [18F]AV1451 / tR of [19F]AV1451 standard); b EU = Endotoxin units