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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.

1

All analytes defined in the

applicability statement are

measured.

1

Fluoride

4-800 μg/100g

5-200 μg/100g

Chloride

4-2400 mg/100g

5-500 mg/100g

Fluoride

Not provided

1.27μg/100g

Chloride

0.006mg/100g

Fluoride

Not provided

4.24μg/100g

Chloride

0.02mg/100g

Spike recovery (%) Fluoride ((5-25μg/100g): 80–120%; (26-200μg/100g):

90–110%)

93.9% (spiked level1), 91.9% (spiked level2)

2

Chloride (95–105%)

100% (spiked level1), 101% (spiked level2)

Bias vs SRM

SRM value not provided

SRM value not provided

3

Fluoride (5-25μg/100g) ≤ 8%; (26-200μg/100g) ≤5%

2.00%

Chloride

1%

Not provided

Fluoride (5-25μg/100g) ≤ 15%; (26-200μg/100g) ≤10%

5.40%

Chloride

2%

b

Units

Other Considerations

Limit of quantification (LOQ)

Method Reference #

2014.016

Method title:

Principle of the method:

Ion Chromatography method for the determination of Fluoride and Chloride in Infant Formula and Adult Nutritionals

Ion Chromatography with suppressed conductivity detection

SMPR Requirement

Analytical Range.

1

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

AOAC SMPR: 2014.016

Limit of detection (LOD)

1

Intermediate Reproducibility

(RSDiR)

a

Concentrations apply to (1) "ready to feed liquids" "as-is"; (2) reconstituted powders (2.50 g into 20 g water); and (3) liquid concentrates diluted (10g in 20g water).

Did Method Author Consider ERP’s Method Specific

Recommendations

(See web link to specific method

comments):

Decision by ERP

Proprietary equipment

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.

Notes:

Overall Score

Recommendation of ERP

2 years after First Action Status

Laboratory safety

3

1

2

Bias against established method

Analytical equipment

1

Adequate proof of performance via system suitability

Is there a bias Yes/No ? No certified value provided in SMPR

Analytical equipment is commonly available in most labs.

SPIFAN ERP Checklist v 1.6

27.06.2013

Fluor-02/Chlor-03 (February 2016) - MEF

FOR ERP USE ONLY

DO NOT DISTRIBUTE