SPSFAM ERP

Table 17. Sample solution stability data

Extract type/Storage

Stability Test (%)

Time (days)

Initial (%) 0.656 12.8 0.869 0.448 14.7 0.656 12.8 0.869 0.448 14.7 0.656 12.8 0.869 0.448 14.7 0.656 12.8 0.869 0.448 14.7 0.656 12.8 0.869 0.448 14.7

% Change 0.2% -3.9% 2.1% 1.8% -2.7% 0.8% -0.8% 1.0% 3.1% 0.0% 1.2% 0.8% -24.1%

Analyte

Final (in vials)/room temperature

Fructose Sucrose Glucose Maltose Fructose Sucrose Glucose Maltose Fructose Sucrose Glucose Maltose Fructose Sucrose Glucose Maltose Fructose Sucrose Glucose Maltose

0.657 12.3 0.887 0.456 14.3 0.661 12.7 0.878 0.462 14.7 0.664 12.9 0.660 0.471 14.7 0.651 12.5 0.885 0.460 14.5 0.681 12.8 0.894 0.468 14.8

4

Total Sugar

7

Total Sugar

14

5.1% 0.0% -0.8% -2.3% 1.8% 2.7% -1.4% 3.8% 0.0% 2.9% 4.5% 0.7%

Total Sugar

Reconstituted/ 5±3°C

4

Total Sugar

14

Total Sugar

Glucose showed signs of degradation in the vial extract at 14 days at room temperature. The refrigerated extract did not show this decreased level of glucose at the 14 day time point. Therefore, the vial stability at room temperature is 7 days, and the extract stability is 14 days when refrigerated. Robustness The effect of utilizing the Carrez protein clean-up steps on matrices that do not require the protein precipitation was evaluated by analyzing NIST 3233 Breakfast cereal and NIST 1849a Infant formula CRMs at each lab site (3 labs for NIST 3233 and 2 labs for NIST 1849a) with 3 replicates over 3 separate days using the protein precipitation procedure. As these matrices had been previously analyzed and showed acceptable method performance based on the CRM ranges without Carrez treatment, the results from the Carrez clean-up were compared to the initial data and to the established ranges for each matrix and analyte. The data are summarized in Table 18 . The full data sets are located in Tables AI-5-1 to AI-5-6 in Appendix I . All results were within the established CRM ranges and consistent with the initial analysis, demonstrating that the Carrez clean-up does not affect the analysis for different matrices. G.