AOAC SPIFAN Final Review Forms (March 16, 2016)

FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

Supporting Data



General Comment:

Contains 1) linearity data, 0.5-100 ng/mL range, greater than 0.9997 coefficient correlation.

2) accuracy and precision on the NIST SRM 1849a excellent. The repeatability are less than 5.2% for

concentration range from 0.12-2.5 ug/100g.

3) recovery results on NIST SRM on vitD2, 101-103%. On four samples within 89-108% at two spike levels.

The four samples are infant formula powder, Milk powder with DHA prebiotics, DHA soy, and High fat AN

ready to feed

4) There is no chromatograms available for review.

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Method Optimization:



Performance Characteristics:

Meet the SMPR requirements in the analytical range, LOQ, Accuracy/Recovery, precision,

Analytical Range:

LOQ:

Accuracy/Recovery:

Precision (RSD

Reproducibility (RSD



System suitability:

There is no system suitability check written in the method.

Recommendation:

There is a concern about the previtamin D content determination in the samples. How accurate the final

vitamin D result is if the previtamin D is not determined.

Recommendation:

1) Evaluate the effect of previtamin D on the final results of vitamin D

2) Regarding the method, suggest to add a purity check step for the standards, a calculation section, and

system suitability check requirement.

VitD-17 Review Forms