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Table 4 Batch information: radioactivity parameters of the automated process

From: Optimised GMP-compliant production of [18F]DPA-714 on the Trasis AllinOne module

Batch information

Batch 1

Batch 2

Batch 3

Starting activity [GBq]

41.82

42.38

34.49

RCY (ndc.) [%]

42

48

47

RCY (dc.) [%]

62

71

70

Activity in bulk vial (post-reaction) [GBq]

17.37

20.31

16.12

Volume in bulk vial (pre-dilution) [mL]

9.83

10.43

10.11

Volume in bulk (post-dilution) [mL]a

34.39

31.32

28.84

Activity concentration in bulk vial [MBq/mL]

505

648

559

Synthesis duration [min]b

63

62

64

  1. aDilution with sterile 0.9% NaCl
  2. bFrom arrival of activity in AIO to measurement of activity in dispensing unit (pre-dilution)