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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
3
Analytical Range: Yes, listed range 0.03 – 5.0 g/100 g meets the SMPR requirement.
The authors may clarify how did they calculate this range. Is it based on the calibration range
adjusted for the sample aliquot weight and dilutions manipulated in the method?
LOQ: Estimated to be 0.018 g/100 g & 0.016 – 0.030 g/100g by two labs. Within SMPR
requirement (<0.03g/100g).
The authors may clarify whether these results are based on blank adjustment or not? The method
now requires blank correction.
Accuracy/Recovery: Six different blank matrices were spiked at three levels with three different
fructan ingredients. At the 2 higher spiking levels recoveries were in general good (92 – 104 %) with
one exception, the adult nutritional RTF high protein sample, for which the average recovery was
only 86 % (SMPR range 90-110%).
The recoveries on the samples with low spike levels even
after blank correction do not meet the SMPR in all cases (for two matrices the recovery
exceeds 110%, being 117% and 119%).
Precision (RSD
r
): RSD(r) for all samples except 1 was between 1.1 – 3.2 %, high RSD of 8.9 % at the
lowest level (0.036 g/100g) only. SMPR requirement for RSDr is <6%. RSD(iR) was between 4.6 –
7.4 % in all samples except at the lowest concentration (0.036 g/100g) where it reached 14%.
Reproducibility (RSD
R
):
•
System suitability:
•
For each analyte (glucose and fructose) use the instrument software to plot a six point standard
curve of (Instrument response for analyte / Instrument response for internal standard) against the
concentration of the analyte in the standard. This can be used as system suitability.
Recommendation:
The method can be considered for First Action if the ERP agrees for some of the noted
exceptions in the method performance in comparisons to the SMPR expectations and answers to some of
the question pointed out in this review.