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Dual Lab Validation of a Method for the Determination of Fructans in Infant
Formula & Adult Nutritionals /
25 Jul 2016
3
and for all but one sample at CCC. The single sample with poorer precision characteristics at CCC
was the sample with the lowest fructan content (0.036 g/100g) which is close to the method LoQ.
The measured fructan content of the 6 fructan‐contining SPIFAN matrices is in good agreement
between the two laboratories and also with the results obtained by the current first action method
for fructans.
The good agreement of results between the two laboratories also indicates that the method is
sufficiently robust to resist the minor changes in protocols between the two labs.
Parameter
SMPR
NRC SLV Results
CCC SLV Results
Meets SMPR?
NRC / CCC
Analytical Range
0.03 – 5.0 g/100 g
0.03 – 5.0 g/100 g
0.03 – 5.0 g/100 g
Y / Y
LoQ
≤ 0.03 g/100 g
0.018 g/100 g
0.016 – 0.030
Y / Y
RSD
(r)
≤ 6 %
0.78 – 3.2 %
1.1 – 8.9
Y / N
a
RSD
(iR)
No target
1.1 – 4.2 %
4.6 – 14 %
b
n/a
RSD
(R)
≤ 12 %
n/a
n/a
Cannot test in SLV
Recovery
90 – 110 % of mean
spiked recovery over
the range of the assay
86 – 119 %
89 ‐ 102
N
c
/ N
d
a
RSD
(r)
for all samples except 1 was between 1.1 – 2.6 %, high RSD of 8.9 % at the lowest level (0.036
g/100g) only.
b
RSD
(iR)
was between 4.6 – 7.4 % in all samples except at the lowest concentration (0.036 g/100g) where it
reached 14%.
c
For 2 out of 6 matrices spiked at 0.03 g/100g recoveries were above 110% (114% and 119%). For 1 matrix
out of 6 spiked at 5g/100g recovery was below 90% (86%). Excluding those 3 results, recoveries were in the
range 92 – 105%.
d
Spike‐recoveries were between 91 – 102% for all samples except 1, which had a spike recovery of 89%.
VALIDATION REPORT
FOR ERP USE ONLY
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