172 / 620
Single Lab Validation Report for GOS in Infant Formula and Adult Nutritionals
6
Formula Powder) and sample 12 (Infant Elemental Powder). These were analyzed in duplicate on 3
different days on 2 instruments without spiking (level 0) and spiked with Vivinal or Clasado GOS, each at
two out of four levels according to Table 1.
Table 1: Design of Spike-Recovery Experiment using Vivinal and Clasado GOS in four SPIFAN matrices
Sample
Level 0
(0g/100g)
Level 1
(0.02g/100g)
Level 2
(0.1g/100g)
Level 3
(0.4g/100g)
Level 4
(0.6g/100g)
7 Adult Nutritional Powder Milk
Protein Based (11750017V3)
None
Vivinal
Clasado
Vivinal
Clasado
10 Adult Nutritional Powder
Low Fat (00394RF00)
None
Clasado
Vivinal
Clasado
Vivinal
11 Child Formula Powder
(00412RF00)
None
Vivinal
Clasado
Vivinal
Clasado
12 Infant Elemental Powder
(00403RF00)
None
Clasado
Vivinal
Clasado
Vivinal
NB: Because of confusion regarding sample preparation, samples were not reconstituted before
analysis. As a result the spiking levels are a factor 9 lower than described in the SMPR.
3
Results
3.1
Linearity
Linearity was assessed using galactose and lactose solutions of concentration from 0.5 to 20 µg/mL in
triplicate (3 independently prepared sets of standards). In the solutions for both components 15 µg/mL
arabinose was present as an internal standard. For both components a linear fit was applied (Figure 1
and 2).
Figure 1: Linear calibration curve for galactose
y = 0.0937x + 0.0209
R² = 0.9995
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
0.00
5.00
10.00
15.00
20.00
Ratio Area/Area IS
Galactose Concentration (µg/mL)
Linear Calibration Curve Galactose
GOS-02 SLV
FOR ERP USE ONLY
DO NOT DISTRIBUTE