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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

3

Accuracy/Recovery:

Recovery was evaluated using unfortified samples within the SPIFAN kit. Each matrix was

spiked at two levels: 50% (≈ 0.6 μg hg

-1

RTF) and 100% (≈ 1.1 μg hg

-1

RTF) of typical infant

formula concentrations. Recoveries measured for vitamin D

2

were between 97–101% and

for vitamin D

3

were between 94–101%, which are within the limits set in the SMPR of 90–

110%.

The method does not have any bias when its results compared against the values generated using

A std. AOAC reference method.

No bias between measured results and certified values for vitamin D3 in NIST SRM 1849a.

Precision (RSD

r

):

Repeatability for the method in SPIFAN kit samples ranged between 1.5–5.2% which

complies with the ≤ 11.0% limit set with the SMPR. The Intermediate precision ranged

between 3.1–7.9% with a mean value of 5.5%

Reproducibility (RSD

R

):

System suitability:

Recommendation:

The method may be considered by the ERP for the First Action Method.