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11

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This equation is the product of two individual factors. The first accounts for the terminal glycosyl loss, either due to the reduction

of the reducing fructosyl moiety of F

n

type fructans or the failure to determine glucose. The second corrects for the water of

hydrolysis. So for example, factor #1 in Table 2-6 is based on the assumption of a fructan with an average degree of

polymerization (DP) of 4.

1.233 =

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The factors chosen for the three groups listed in Table 2-6 were done in such a way so as to cover the known spectrum of fructan

commodities currently in use. Any factor should then impart a bias of no more than ~5% for the grouping that it covers.

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 of three days in duplicate also performed. Data also analyzed in

Microsoft Excel.

3.

Precision

Data was analyzed in Microsoft Excel and Minitab.

a.

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, a total of 80 analyses of Abbott internal control were

collected in a total of 3 labs (60 points collected as 10 days of duplicate analyses in three labs, the remaining 20

were single determinations at Abbott Columbus). This data is also included for the sake of

b.

Performed 6 days of duplicate testing on SPIFAN matrices (for the 6 products fortified with fructan material).

Calculated run-to-run %RSD, within-run %RSD, and total (intermediate) %RSD.

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 and multiple products containing either hydrolysate protein or free amino acids. Lastly it was checked by

the analysis of SPIFAN matrices known to not be fortified with fructan material.

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

2-7.

Fos-04 (February 2016)

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