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

Residue Plot Lactose Quadratic

8

6

4

2

0

0.00

5.00

10.00

15.00

20.00

-2

-4

-6

-8

% deviation from actual concentration

-10

Lactose Concentration (µg/mL)

Figure 8: Residue plot of the deviation from the actual concentration by quadratic calibration for lactose

3.2 Precision Only three of the fortified products contained GOS. They were all analyzed in duplicate on three different days on two instruments. Raw data is given in Appendix 5.2 and Table 2 shows the summarized results.

Table 2: Assessment of method precision using three SPIFAN kit matrices

Meets SMPR requirements?

Sample

Level (g/100g)

%RSD(r)

%RSD(R)

8 IF Powder Partially Hydrolyzed Milk Based (1172572116) 13 Infant Formula Powder Milk Based (D04HTCVV) 15 Infant Formula RTF Milk Based (SPIFAN Control Milk Form)

0.309

1.9

4.1

Yes

0.235

3.7

4.4

Yes

0.189

2.0

9.9

Yes

The SPMR requires that RSD(r) and RSD(R) are ≤ 6% and ≤ 12%, respectively. Therefore, precision criteria are met.

3.3 Accuracy Four of the SPIFAN kit matrices were selected for use in spike-recovery experiments. Each matrix was spiked at 4 levels with Vivinal or Clasado GOS according to the scheme described in Table 1. The raw data is available in Appendix 5.3 and is summarized in Table 3.

10