AOAC SPIFAN ERP Meeting Book-March 16, 2016

FOS-01 MEF Form FOR ERP USE ONLY DO NOT DISTRIBUTE

Evaluation of Method Performance  vs. SMPR requirements.

AOAC SMPR: 2014.002

AOAC 997.08

Method Reference # Method title: Principle of the method:

Fructans in food products enzymatic chromatographic method

Weighting  factor for  parameter

Suitability Ranking (1‐ 3‐5)  (select from drop‐down  list, 5 = best)

Method Performance                Please  report in units as stated in SMPR!

SMPR Requirement

Parameter

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.

SLV Test Material Kit for FOS provided by  Covance

1

 SPIFAN matrices

All analytes defined in the  applicability statement are  measured.

1

Fructans

 g/100g reconstituted final product

Analytical Range.

1

0,03 ‐ 5,0%

Analyte 1 Analyte 2 Analyte 3 Analyte 4 Analyte 5 Analyte 1 Analyte 2 Analyte 3 Analyte 4 Analyte 5

not relevant

Limit of detection (LOD)

1

≤ 0,03

≤ 0,03

Limit of quantification (LOQ)

2

2

Spike recovery  (%)

90‐110% of mean spiked recovery 

100.3

Accuracy/Recovery

3

Bias vs SRM

no SRM available

not applicable

3

Repeatability (RSDr)

6

≤ 6%

Intermediate Reproducibility  (RSDiR)

1

7

1

Reproducibility (RSDR)

≤ 12%

ADDITIONAL EVALUATION PARAMETERS

Adequate proof of performance via system suitability

Feedback from Users of the Method since being awarded  First Action Official Methods  Status Did Method Author Consider ERP’s Method Specific  Recommendations  (See web link to specific method  comments):

Bias against established method 

Is there a bias Yes/No ?

Analytical equipment

Analytical equipment is commonly available in most labs.

Proprietary equipment

No unique proprietary equipment/accessories are required.

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

Laboratory safety

Other Considerations

0

Overall Score

Decision by ERP

Recommendation of ERP  2 years after First Action Status

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

Notes:

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.

b    Units

SPIFAN ERP Checklist v 1.6

27.06.2013