SPIFAN Nutrients ERP Book_9-29-15

GOS-02 SLV FOR ERP USE ONLY DO NOT DISTRIBUTE

Single Lab Validation Report for GOS in Infant Formula and Adult Nutritionals

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

Level 0 (0g/100g)

Level 1 (0.02g/100g)

Level 2 (0.1g/100g)

Level 3 (0.4g/100g)

Level 4 (0.6g/100g)

Sample

7 Adult Nutritional Powder Milk Protein Based (11750017V3) 10 Adult Nutritional Powder Low Fat (00394RF00) 11 Child Formula Powder (00412RF00) 12 Infant Elemental Powder (00403RF00)

None

Vivinal

Clasado

Vivinal

Clasado

None

Clasado

Vivinal

Clasado

Vivinal

None

Vivinal

Clasado

Vivinal

Clasado

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.

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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).

Linear Calibration Curve Galactose

2

y = 0.0937x + 0.0209 R² = 0.9995

1.8

1.6

1.4

1.2

1

0.8

0.6

Ratio Area/Area IS

0.4

0.2

0

0.00

5.00

10.00

15.00

20.00

Galactose Concentration (µg/mL)

Figure 1: Linear calibration curve for galactose

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