108 / 112
Exchange ofthimerosal
Page 16
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
27.2
11.2
10.4
14.7
Quality dept. release test 1
37.0
13.8
12.6
20.9
Quality dept. release test 2
34.5
14.7
11.6
25.1
Quality dept. release test 3
34.0
14.6
13.1
16.8
Quality dept. release test 4
25.7
9.9
8.5
12.4
Stabilitytest4 months
43.5
-
14.9
18.1
Stabilitytest8 months
26.5
-
11.5
16.3
Stabilitytest12 months
18.1
8.9
-
-
Stabilitytest16 months
30.3
-
11.9
16.2
MW
30.8
12.2
11.8
17.6
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