SPIFAN Nutrients ERP Book_9-29-15

FOS-04 FOR ERP USE ONLY DO NOT DISTRIBUTE

Table 2-3 CF’s

Commodity type

CF

1

scFOS and oligofructose (DP= 3.60-4)

1.233

2 H.S.I., Synergy 1 and native inulin (DP = 5.49-10)

1.068

3

Enriched Inulin (Avg. DP= 11-50)

0.9526

Validation Protocol

1. Linearity – A total of 43 standard curves were collected. Linearity Data analyzed in Microsoft Excel. 2. Accuracy – Triplicate analyses of spiked samples on each of three days. Data analyzed in Microsoft Excel. a. Additional testing on SPIFAN matrices is intended, but not yet completed. 3. Precision – Duplicate analyses of products on each of 10 days Calculated run-to-run %RSD, within-run %RSD, and total (intermediate) %RSD in 2 separate labs. Additionally, collected a total of 37 additional analyses of Abbott internal control in a total of 3 labs. Data analyzed in Microsoft Excel and Minitab. a. Performed 4 days of duplicate testing on SPIFAN matrices. Additional data to be acquired. 4. Specificity – Specificity was demonstrated by analysis of spiked samples containing GOS (known amount of fructan spiked in). Additionally checked for other chromatographic interferences by analysis of multiple maltodextrin commodities. 5. MDL/LOQ – The LOQ was empirically demonstrated by analysis of a low level spike solution.

Results and Discussion

Method Development

The method described here is based on methods that were previously published. The principle differences are summarized in Table 2-4 below.

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