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Table 2 [13N]Ammonia TLC method validation results

From: Development, validation and regulatory acceptance of improved purification and simplified quality control of [13N] Ammonia

[13N]Ammonia

% [13N]Ammonia integrated

Peak Start (mm)

Peak End (mm)

Peak centroid (mm)

Rf Value

Resazurin Standard Range (mm)*

[13N]Ammonia – TLC Strip #1

99

20.3

81.8

50.8

0.846

0–40

[13N]Ammonia – TLC Strip #2

98.96

17.7

79.2

51.7

0.862

0–40

[13N]Ammonia – TLC Strip #3

99.06

17.7

80.1

51.2

0.853

0–45

Mean

99.01%

   

0.854

 

[18F]Fluoride

%[18F]Fluoride integrated

Peak Start (mm)

Peak End (mm)

Peak centroid (mm)

Rf Value

Resazurin Standard Range (mm)*

[18F]Fluoride – TLC Strip #1

99.5

− 17.3

30.5

7.1

0.119

0–41

[18F]Fluoride – TLC Strip #2

99.78

−16.5

25.4

4.3

0.072

0–44

[18F]Fluoride – TLC Strip #3

99.77

−15.6

30.5

5.7

0.095

0–44

Mean

99.68

   

0.095

 

[13N]NOx

% [13N]NOx integrated

Peak Start (mm)

Peak End (mm)

Peak centroid (mm)

Rf Value

Resazurin Range (mm)*

[13N]NOx – TLC Strip #1

98.34

−12.4

14.4

0.1

0.00

0–40

[13N]NOx – TLC Strip #2

97.94

−13.2

13.5

−0.8

−0.01

0–41

[13N]NOx – TLC Strip #3

98.21

−14.1

14.4

− 0.6

−0.01

0–40

Mean

98.16

   

−0.01

 

[18F]Fluoride / [13N]Ammonia Mixed Solution (Co-spot)

% integrated

Peak Start (mm)

Peak End (mm)

Peak centroid (mm)

Rf Value

Resazurin Range (mm)*

[18F]Fluoride (4% impurity)

3.6%

−12.1

24.75

18

0.3

0–44

[13N]Ammonia (96% purity)

96.4%

31.5

80.1

49.5

0.82

Total

100%

     

Accuracy of [18F]Fluoride measurement

90% of expected value

     

Accuracy of [13N]Ammonia measurement

100.4% of expected value

     
  1. *A valid system suitability result requires the front of the resazurin spot to be 34–50 mm