AOAC SPIFAN Final Review Forms (March 16, 2016)

FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

Accuracy/Recovery:

Vitamin D2: 97 – 101% (mean = 98%); (SMPR 90-110%)

Vitamin D3: 94 – 101% (mean = 98%); (SMPR 90-110%)

vs. NIST SRM

Vitamin D2: NAP

Vitamin D3: within certified range

Precision as Repeatability (RSD

Vitamin D2: NAP, none of SPIFAN matrices contain vitamin D2

Vitamin D3: 1.5 – 5.3% (mean = 3.0%); (SMPR ≤11%)

Reproducibility (RSD

NAP



System suitability:

I did not see any defined system or method performance suitability criteria defined within the method

text. Performance requirements around injection precision, standards stability, curve performance

(linearity, residuals, IS recovery), chromatography (eg. RT, symmetry, peak width, etc) should be added.

Recommendation:

First Action

VitD-18 Review Forms