AOAC SPIFAN Nutrients ERP Review (March 14, 2019)

2016.13 (Jan. 2019) Carot-02 MLT Report FOR ERP USE ONLY DO NOT DISTRIBUTE

Figure 15. Plotted raw data for β-carotene in 4052755861, Toddler milk-based formula powder.

β-Carotene Precision Raw data for all- trans -β-carotene and total β-carotene is shown in Tables 7 and 8. When precision data was initially calculated, it was evident that the elemental infant formula sample (00795RF) had widely variable results. Its repeatability and reproducibility for all- trans -β- carotene were both 33.6% RSD. The repeatability and reproducibility for total β-carotene were both 35.5% RSD. Post hoc homogeneity testing was done with 6 cans of the product, three cans each of UOPM297 and ECHL425. While 5 of the 6 cans had similar β-carotene concentrations, one can had much lower levels (Appendix B). A strong rancid odor indicated oxidation of the product with reduced β-carotene. Although this product was originally tested for homogeneity in 2015, it appears that it is no longer homogeneous and the MLT data for this product should be considered invalid. After data for elemental infant formula and outliers were removed, the repeatability for all- trans - β-carotene ranged from 2.0 to 4.2% RSD and repeatability for total β-carotene ranged from 1.1 to 6.0% RSD (Tables 9 and 10). Reproducibility for all- trans -β-carotene ranged from 7.4 to 15.3% RSD and for total β-carotene it ranged from 8.5 to 13.7% RSD. The repeatability and reproducibility values met the criteria in the SMPR. Figures 16 and 17 show that all HorRat values for all- trans -β-carotene and total β-carotene are below 1.0.

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