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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