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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 2 / 35
S U M M A R Y
Methodology and Trials
The SLV was performed on the SPIFAN matrix kit containing 19 different matrices, two products
purchased in a Swiss supermarket, and a Nestlé reference sample. Of the 19 matrices in the SPIFAN
kit, 5 were found to contain GOS. Those 5 and the other 3 materials were analysed on 6 different
days in duplicate to determine the precision of the method. Of the 14 GOS‐free samples, 4 were
selected for use in spike/recovery experiments. The four matrices were spiked with 2 different GOS
ingredients at four different levels.
Results and Conclusions
The results of the SLV are summarized in the table below. The single lab precision data are better
than required by the SMPR. However, the spike recoveries are in general slightly below the SMPR
guidelines (with one result being high). However, the method is currently the only solution
available for determination of GOS in lactose‐containing matrices.
Parameter
SMPR
SLV Results
Meets SMPR?
Analytical Range
0.2 – 5.0 g/100 g
0.2 – 5.0
Y
LoQ
≤ 0.2 g/100 g
≤ 0.15 g/100 g
a
Y
RSD
(r)
≤ 6 %
1.0 ‐3.6 %
Y
RSD
(iR)
No target
1.7 – 7.9 %
n/a
RSD
(R)
≤ 12 %
n/a
Cannot test in SLV
Recovery
90 – 110 % of mean
spiked recovery over
the range of the assay
85 – 114 %
N
a
The method LoQ depends strongly on the GOS oligosaccharide profile. The value of 0.15 g/100g has been estimated
from the spike/recovery and precision data recorded during this SLV.
VALIDATION REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE