AOAC SPIFAN Final Review Forms (March 16, 2016)

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FOR EXPERT REVIEW PANEL USE ONLY
NOT FOR DISTRIBUTION
2
Supporting Data
 General Comment:
Validation data obtained on SPIFAN kit and NIST SRM 1849a. The data include linearity, precision,
sensitivity, recovery, accuracy against SRM and AOAC 2002.05 method.
Chromatograms of vitD2 and vitD3 in samples are provided as well as the product ion scan mass spectra of
derivatized standards.
– Method Optimization: No optimization data provided.
 Performance Characteristics:
Meet the SMPR requirements in the analytical range, LOQ, Accuracy/Recovery, precision,
Analytical Range:
LOQ:
Accuracy/Recovery:
Precision (RSDr):
Reproducibility (RSDR):
 System suitability:
System suitability criteria is not provided.
Recommendation:
One serious concern is the determination of the previtamin Ds. The author discussed about the pre-vitamin
D determination in the method. Author made two major assumptions, one is that the pre-vitamin D and
vitamin D in the sample after saponification have reached equilibrium; 2) the equilibrium constant and
kinetics are the same for the analytes and the isotope labelled forms of vitamin D.
VitD-18 Review Forms