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Parameter

Method Performance

Please

report in units as stated in SMPR!

Weighting

factor for

parameter

Suitability Ranking (1-

3-5)

(select from drop-down

list, 5 = best)

SPIFAN matrices

Applicable to all forms of infant, adult, and/or pediatric

formula (powders, ready-to-feed liquids, and liquid

concentrates).

Any combination of milk, soy, rice, whey, hydrolyzed

protein, starch, and amino acids, with and without intact

protein.

yes

1

All analytes defined in the

applicability statement are

measured.

yes

1

0.03-5% (as-fed)

45-100% (ingredient commodity)

Analyte 1

NA

Analyte 2

Analyte 3

Analyte 4

Analyte 5

Analyte 1

0.03

0.03% (as-fed)

Analyte 2

Analyte 3

Analyte 4

Analyte 5

Spike recovery (%)

90-110%

92.9-108%

2

Bias vs SRM

NA

NA

3

≤6%

1.09-3.67

2.46-6.79

≤12%

≤12%

≤12%

≤12%

≤12%

b

Units

Analytical Range.

1

Method title:

Principle of the method:

Determination of Fructans in Infant and Adult/Pediatric Nutritional Formula as well as ingredient commodities

Qualitative ID of fructan present in material and then quantitative analysis of fructan content (both using HPAEC-PAD instrumentation).

SMPR Requirement

Evaluation of Method Performance vs. SMPR requirements.

Feedback from Users of the Method since being awarded

First Action

Official Methods

Status

Repeatability (RSDr)

Reproducibility (RSDR)

Accuracy/Recovery

ADDITIONAL EVALUATION PARAMETERS

Intermediate Reproducibility

(RSDiR)

Limit of quantification (LOQ)

Method Reference #

FOS-04

AOAC SMPR: …2014.002………..

Limit of detection (LOD)

1

a

Concentrations apply to (1) "ready to feed liquids" "as-is"; (2) reconstituted powders (25 g into 200 g water); and (3) liquid concentrates diluted 1:1 by weight.

Did Method Author Consider ERP’s Method Specific

Recommendations

(See web link to specific method

comments):

Decision by ERP

Proprietary equipment

Notes:

Overall Score

Recommendation of ERP

2 years after First Action Status

Laboratory safety

Other Considerations

3

1

move to Final Action/repeal/remove/expand 2 year term

0

No unique proprietary equipment/accessories are required.

Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.

2

Bias against established method

Analytical equipment

1

Adequate proof of performance via system suitability

Is there a bias Yes/No ?

Analytical equipment is commonly available in most labs.

SPIFAN ERP Checklist v 1.6

27.06.2013

Fos-04 -MEF (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE