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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.
FOS-04
FOR ERP USE ONLY
DO NOT DISTRIBUTE