AOAC SPIFAN ERP Meeting Book-March 16, 2016

2011.06 (Fol-22) MEF Form FOR ERP USE ONLY DO NOT DISTRIBUTE

Evaluation of Method Performance  vs. SMPR requirements.

AOAC SMPR: ………….. 2011.06

Folate‐22 (OMA 2011.06)

Method Reference # Method title: Principle of the method:

Folate Analysis in Infant Formula and Adult Nutritional Samples An UPLC‐MS/MS method for determining total folate after trienzyme digestion of the food matrix. Important folate vitamers are analyzed and sum of those as folic acid is  calculated.

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.

1

 SPIFAN matrices

All analytes defined in the  applicability statement are  measured.

1

Yes

0.5 ‐ 300 mcg/100g

0.3 ‐ 500 mcg/100g

Analytical Range.

1

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

0.10 mcg/100g

0.09 mcg/100g

Limit of detection (LOD)

1

0.5 mcg/100g

0.3 mcg/100g

Limit of quantification (LOQ)

2

2

Spike recovery  (%) 90‐110

93‐104

Accuracy/Recovery

3

Bias vs SRM SRM 1849  2.38 mcg/100g

2.42 mcg/100g

2.7% (1.1 mcg/100g)

0.5 mcg/100g 22‐85 mcg/100g

11% or less  RSD 7% or less RSD

7 ‐ 12.7% (20‐66 mcg/100g)

3

Repeatability (RSDr)

2.7% (1.1 mcg/100g)

0.5 mcg/100g 22‐85 mcg/100g

11% or less  RSD 7% or less RSD

7 ‐ 12.7% (20‐66 mcg/100g)

Intermediate Reproducibility  (RSDiR)

1

1

Reproducibility (RSDR)

ADDITIONAL EVALUATION PARAMETERS

Blank Check sample and check standards at the  lowest point and midrange point of the analytical 

Adequate proof of performance via system suitability

Blank Check sample and check standards at the lowest point 

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

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