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Single Lab Validation of a Method for the Determination of β‐
Galactooligosaccharides in Infant Formula & Adult Nutritionals / Sean Austin (NRC,
Lausanne)
25 Jul 2016
CONFIDENTIAL
∙ This document may not be reproduced or disclosed to third parties without prior authorization
Page 13 / 35
2.3.3 Accuracy
Four matrices were selected that covered both infant formula and adult nutritionals (see Table 4 for
details). They were analysed in duplicate on three different days by two different operators on two
different instruments without spiking (level 0) and spiked with Vivinal GOS or Clasado GOS, each at
two out of four levels (Table 4). The GOS ingredients used for spiking were separately analysed using
method AOAC 2001.02 [1] to confirm their GOS content.
Table 4: Design of Spike-Recovery Experiment Using Three Fructan Ingredients in Six SPIFAN Matrices
Nestlé
Code
Sample
Level 0
(0 g/100g)
Level 1
(0.2 g/100g)
Level 2
(1 g/100g)
Level3
(2.5 g/100g)
Level 4
(5.0 g/100g)
KBI‐00046
Child Formula
Powder
none
Clasado
Vivinal
Clasado
Vivinal
L3B‐00037
Adult Nutritional RTF
High Protein
none
Vivinal
Clasado
Vivinal
Clasado
KBI‐00047
Infant Elemental
Powder
none
Clasado
Vivinal
Clasado
Vivinal
KBI‐00045
Adult Nutritional Powder
Low Fat
none
Vivinal
Clasado
Vivinal
Clasado
2.3.4
Limit of Quantification
Because the method requires analysis of a complete profile of oligosaccharides, the detection and
quantification limits depend on the GOS profile as well as the concentration of GOS in the product,
making it extremely difficult to assess (except on an individual oligosaccharide basis, which is
meaningless for GOS products). Therefore to demonstrate applicability at the LoQ defined in the
SMPR, spike‐recovery experiments have been performed at 0.2 g/100g.
VALIDATION REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE