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Table 1 Results of three validation batches of [99mTc]Tc-PSMA

From: Automated synthesis and quality control of [99mTc]Tc-PSMA for radioguided surgery (in a [68Ga]Ga-PSMA workflow)

Item

Time (hours)

Batch 1

Batch 2

Batch 3

Syringe

Vial

Syringe

Vial

Syringe

Vial

Yield

(Corrected for decay)

T = 0

75.05%

77.94%

74.82%

Visual inspection(Criteria: colorless without visible particles)

T = 0

Colorless

No particles

Colorless

No particles

Colorless

No particles

T = 4

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

T = 6

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

Colorless

No particles

T = 24

Colorless

No particles

Colorless

No particles

    

pH

(Criteria: pH 4,0-8,0)

T = 0

7.5

7.5

7.5

T = 4

7.5

7.5

7.5

7.5

7.5

7.5

T = 6

7.5

7.5

7.5

7.5

7.5

7.5

T = 24

7.5

7.5

    

Sterility

(Criteria: TSB clear after 7-day incubation)

T = 0

TSB clear

TSB clear

TSB clear

Endotoxin

(Criteria: < 50 IU / 2 mL)

T = 0

< 50 IU/2 ml

< 50 IU/2 ml

< 50 IU/2 ml

Radionuclide purity

(Main peak at 141 keV)

T = 0

Main peak at 141 keV

Main peak at 141 keV

Main peak at 141 keV

Tc-99m colloids

(Criteria: ≤10%)

T = 0

1,46%

1,92%

2,82%

T = 4

6,56%

7,02%

6,83%

7,39%

7,81%

6,64%

T = 6

6,65%

7,18%

7,60%

6,47%

8,51%

8,40%

T = 24

10,96% *

9,44%

    

Tc-99m ions

(Criteria: ≤2%)

T = 0

0,34%

0,48%

0,84%

T = 4

0,68%

1,06%

0,28%

0,78%

1,22%

0,90%

T = 6

0,58%

1,02%

0,82%

1,10%

1,10%

1,56%

T = 24

1,46%

1,34%

    

Radiochemical purity

(Criteria: ≥90%)

T = 0

98,20%

97,60%

96,34%

T = 4

92,76%

91,92%

92,89%

91,83%

90,97%

92,46%

T = 6

92,77%

91,80%

91,58%

92,43%

90,39%

90,04%

T = 24

87.58% *

89,22% *

    

HEPES

(Criteria: < 200 μg/patient dosage)

T = 0

< 200 μg/patient dose

< 200 μg/patient dose

< 200 μg/patient dose

  1. The results of the three validation batches (batch 1, batch 2, batch 3) are shown at different time points (t = 0, t = 2, t = 6, and t = 24 h). At t = 0 one sample was taken, whilst at the other time points a samples was measured from either the final vial or a prepared patient syringe kept at room temperature. The accepted limit/criteria is noted in the first column. * indicates that the value does not meet the criteria