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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
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Average low recovery values for Level 2-4 samples (~90%).
-
Many steps in sample preparation, which increase the probability of errors.
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Two routes of sample preparation per sample are necessary.
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Time consuming steps in sample preparation.
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Specific enzymes needed, or activity/side-activity of each individual enzyme should be tested in
advance.
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Use of a not so common system set-up on the UPLC.
Supporting Data
•
General Comment:
The set-up of the methods was according to the SLV requirements.
•
Method Optimization:
The method is less labor intensive than GOS-02, but sample preparation is still time-consuming. Compared
to the current reference method (AOAC2001.02) this new method seems to be more accurate. However,
the method does not meet SMPR conditions for recovery.
•
Performance Characteristics:
Analytical Range: 0.2-5.0%
LOQ: ≤0.15%
Accuracy/Recovery: 85-114%
Precision (RSD
r
): 1.0-3.6%
Reproducibility (RSD
R
): Not tested in SLV
•
System suitability:
OK
Recommendation:
We do not recommend first action approval. The method is more complex than the current reference
method, an MS is needed and the accuracy/recovery numbers do not meet the SMPR requirements.