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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

5

All analytes defined in the

applicability statement are

measured.

1

5

0.12-5.1

0.05-10

Vitamin D

2

≤0.02

0.0003

Vitamin D3

≤0.02

0.00038

Analyte 3

Analyte 4

Analyte 5

Vitamin D2 and D3 ≤0.12

0.00081

Vitamin D3

≤0.12

0.00096

Analyte 3

Analyte 4

Analyte 5

Spike recovery (%)

97

2

5

Bias vs SRM

4%

3

5

0.12

≤15%

vitamin D2 3.5%

1.5

≤1

1

%

vitamin D3 3%;vitamin D2 5.2%

2.5

≤1

1

%

vitamin D2 4.1%

5.1

≤1

1

%

1

1

1

1

5

5

5

1

b

Units

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.

2

5

5

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

92

No unique proprietary equipment/accessories are required.

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

3

1

AOAC SMPR: AOAC SMPR 2011.004

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

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

5

1

5

ADDITIONAL EVALUATION PARAMETERS

Notes:

Overall Score

Intermediate Reproducibility

(RSDiR)

1

Recommendation of ERP

2 years after First Action Status

Laboratory safety

Other Considerations

Limit of quantification (LOQ)

Method Reference #

Method title:

Principle of the method:

Determination Method for Vitamin D derivatized with 4-phenyl-1,2,4-triazoline-3,5-dione(PTAD) in Milk Powder by UHPLC-MS/MS

Test sa ples are saponified, extracted, and the solvent evaporated. Vitamin D is derivatized with 4-phenyl-1,2,4-triazoline-3,5-dione, and then determined by UHP

SMPR Requirement

Analytical Range.

1

SPIFAN ERP Checklist v 1.6

27.06.2013

VitD-17 MEF (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE