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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 15 / 35
5.2. Analytical Precision
(QSTAT 65117)
Method precision was assessed in a single laboratory by analyzing the samples on 6 days in
duplicate. Analyses were performed by two operators on two different instruments (of same
model) using two different columns (same column type, different batch number), results are shown
in Table 5.
The SMPR [2] requires that the RSD(r) should be less than or equal to 6%. In all cases the achieved
RSD(r) was less than 4%, thus the method meets the requirements of the SMPR for RSD(r). The
RSD(iR) was less than 8% in all cases suggesting that the method should be able to achieve an
RSD(R) of less than 12% during multi lab testing (as required in the SMPR).
Table 5: Analyses of GOS-Containing Samples Under Intermediate Reproducibility Conditions
Nestle
Code
Sample Description
n
Mean Conc.
(g/100g)
RSD(r)
(%)
RSD(iR)
(%)
Target
RSD(r)
(%)
Meets
Target
(Y/N)
KBI‐00031
Infant Formula RTF,
Milk Based
6×2
0.154
2.7
7.9
≤ 6
Y
KBI‐00033
Infant Formula
Powder Partially
Hydrolysed, Milk
Based
6×2
0.333
3.6
4.9
≤ 6
Y
KBI‐00053
Infant Formula
Powder
FOS/GOS Based
6×2
0.309
2.0
2.4
≤ 6
Y
KBI‐00048
Infant Formula
Powder
Milk Based
6×2
0.266
1.1
4.0
≤ 6
Y
KBI‐00049
Infant Formula RTF,
Milk Based
6×2
0.157
3.1
5.9
≤ 6
Y
L4B‐00006
Infant Formula
Powder with GOS
6×2
0.509
1.3
1.7
≤ 6
Y
L4B‐00007
Infant Formula
Powder with GOS/FOS 6×2
0.351
1.0
3.0
≤ 6
Y
Ref 56A
Infant Formula
Powder with GOS/FOS 6×2
2.59
*
2.0
2.9
≤ 6
Y
All results reported on a “ready‐to‐feed” basis except * reported as the concentration in the non‐reconstituted powder
VALIDATION REPORT
FOR ERP USE ONLY
DO NOT DISTRIBUTE