AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

AOAC SMPR 2011.004

Criteria

Value

Analytical Range Limit of Detection Limit of Quantitation

0.12–5.1 µg/100g b

b

b

0.12–1.5 µg/100g b >1.5 µg/100g b 0.12–1.5 µg/100g b

Repeatability (RSD r )

80– 90–

Recovery

>1.5 µg/100g b

Reproducibility (RSD R ) a Concentrations apply to (1) “ready-to-feed” liquids “as is”; (2) reconstituted powders (25 g into 200 mL water); and (3) liquid concentrates diluted 1:1 by weight. b µg/100 g expressed separately as vitamin D 2 and vitamin D 3 in reconstituted final product.

Predicted non-Compliance Rate

Method Reproducibility = 6.4% RSD Measured results on sample with a true value at the mid- results for Stage I Infant Formula will exceed the regulatory limits.

Method Reproducibility = 11.4% RSD Measured results on sample with a true value at the mid- results will exceed the regulatory limits