AOAC-RI ERP Book - Gluten.pdf

7.4.2 Variation of a reference Gliadin competitive lot with thimerosal wash buffer

Annex table 5 shows the B/Bmax values of the standards as well as the calculated concentrations of control samples for the reference Gliadin competitive lot.

Control A (mg/kg)

Control B (mg/kg)

Control C (mg/kg)

Control D (mg/kg)

Final test in production Quality dept. release test 1 Quality dept. release test 2 Quality dept. release test 3 Quality dept. release test 4 Stabilitytest4 months Stabilitytest8 months Stabilitytest12 months Stabilitytest16 months

27.2 37.0 34.5 34.0 25.7 43.5 26.5 18.1 30.3 30.8

11.2 13.8 14.7 14.6

10.4 12.6 11.6 13.1

14.7 20.9 25.1 16.8 12.4 18.1 16.3

9.9

8.5

- -

14.9 11.5

8.9

-

-

-

11.9 11.8

16.2 17.6

MW

12.2

STABW

7.4

2.5

1.9

3.9

CV

24.2%

20.7%

16.0%

22.3%

Darmstadt, August 11 th 2016 Thomas Weiss Research and Development Food Allergens R-Biopharm AG An der neuenBergstrasse 17 64297 Darmstadt Germany

Markus Lacorn Validation Manager R-Biopharm AG An der neuenBergstrasse 17 64297 Darmstadt Germany

Exchange ofthimerosal

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