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Dual Lab Validation of a Method for the Determination of Fructans in Infant 

Formula & Adult Nutritionals /        

25 Jul 2016

41 

Table 4 

Summarizing results of the LOD and LOQ determination in the  

reconstituted sample no 7, Infant formula powder partially hydrolyzed  

milk based. 

February 28

th

, 2016 

May 23

rd

, 2016 

Fructan 

(%m/m) 

Meet 

requirements

Fructan (%m/m) 

Meet 

requirements 

0.044 

0.048 

SD

0.002 

0.003 

LOD = 3 x SD

0.005 

Yes 

0.009 

Yes 

LOQ = 10 x SD

0.016 

yes 

0.030 

yes 

In which:

x

i

 = individual result of the measured fructan content in the spiked sample 

  = average fructan content

SD

 = repeatability standard deviation in the average fructan content 

Moreover these data can also be applied to calculate the average recovery of the spiked amounts 

fructan in both series. The fructan addition was 0.046 % and the average fructan content in the tenfold 

analyses was 0.044 (Febr. 28) respectively 0.048 % (May 23), corresponding with average recoveries of 

95.6 and 104.3% of the added amount fructan. This is very well within the target range of 90 – 110 %. 

d.

Precision 

Based on the analytical results reported in table 2, 6 of the 7 fructan containing not‐reconstituted 

samples (marked in yellow in table 2) are selected for this precision study. Sample 8 was excluded. The 

fructan content in the reconstituted sample 8 will be less than the LOQ. And after spiking this sample 

with 50% and 150% of its original fructan content, the spiked fructan content is still less than the LOQ 

meaning that this experiment will not result in reliable data. 

The analyses for this precision study have been done at six different days in the period March – June 

2016 by 2 different technicians and applying three different HPAEC‐PAD instrument (one ICS3000 

instrument and two different ICS5000 instruments) and each instrument was equipped with its own 

chromatographic column (Carbopack PA‐1). 

The results of the precision study are summarized in table 5. All experimental results of this precision 

study are given in Annex D 

x

x

VALIDATION REPORT

FOR ERP USE ONLY

DO NOT DISTRIBUTE