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FOR EXPERT REVIEW PANEL USE ONLY

NOT FOR DISTRIBUTION

3

Concerned with high RSD with Child Elemental Powder being 14.88% RSD on a sample with levels

around 34 mcg/100g. Other high RSDs are with samples sub 1 mcg/100 levels, so not as concerned. RSDs

on remaining products meet the SMPR requirements of <8% for the levels found in the product.

Reproducibility (RSD

R

): N/A

System suitability:

System suitability was not stated in the method.

Recommendation: Move to First action after investigation of low lutein spike recoveries.