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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.

All SPIFAN matrices evaluated met precision and

accuracy requirements for all four vitamins.

Precision = 14 matrixes evaluated

Accuracy = 8 unique matrixes evaluated.

All analytes defined in the

applicability statement are

measured.

Total B1, B2, B3, and B6

Method determines these four vitamins simultaneously

from the same injection

all units ug/100g of RTF

Total B1

20 - 2000

same

Total B2

30 - 4000

same

Total B3

200 - 10000

same

Total B6

10 - 2000

nearly same

Total B1

≤ 20

9.79

Total B2

≤ 30

8.65

Total B3

≤ 200

95.2

Total B6

≤ 10

12.75

Total B1

92.4 - 102.5, mean 97.1% recovery

Total B2

95.1 - 100.7, mean 97.9% recovery

Total B3

100.3 -

110.7

, mean 103.8% recovery

Total B6

96.8 - 100.5, mean 99.1% recovery

Total B1

2.2% higher than certified

Total B2

11.5% higher than certified

Total B3

4.7% lower than certified

Total B6

1.7% higher than certified

Total B1

≤ 5%

1.1

Total B2

≤ 5%

2.3

Total B3

≤ 5%

1.2

Total B6

≤ 5%

1.5

Total B1

not stated

3.4

Total B2

not stated

5.1

Total B3

not stated

2.8

Total B6

not stated

4.4

Total B1

≤ 10%

not tested yet

Total B2

≤ 10%

not tested yet

Total B3

≤ 10%

not tested yet

Total B6

≤ 10%

not tested yet

b

Units

Bias against established method

Analytical equipment

Adequate proof of performance via system suitability

Is there a bias Yes/No ?

Analytical equipment is commonly available in most labs.

No unique proprietary equipment/accessories are required.

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

Samples are enzymatically digested with a stable isotope labeled internal standard and analyzed by LC-MS/MS.

Limit of quantification (LOQ)

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

Laboratory safety

Other Considerations

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

0

Intermediate Reproducibility

(RSDiR)

Evaluation of Method Performance vs. SMPR requirements.

Feedback from Users of the Method since being awarded

First Action

Official Methods

Status

Reproducibility (RSDR)

ADDITIONAL EVALUATION PARAMETERS

SMPR Requirement

AOAC SMPR: 2015.002, 2015.003, 2015.004, and 2015.005

Method Reference #

BVIT-02

Method title:

Principle of the method:

Simultaneous Determination of Total Vitamin B6, B2, B3 and B1 in Infant Formula Products by LC-

MS/MS using Enzyme Digestion

Analytical Range.

Notes:

Overall Score

Recommendation of ERP

2 years after First Action Status

90-110 % mean spiked recovery over the Range

Spike recovery (%)

Bias vs SRM

Use SRM 1849a

Repeatability (RSDr)

SPIFAN ERP Checklist v 1.6

27.06.2013

BVit-02 - MEF FORM

FOR ERP USE ONLY

DO NOT DISTRIBUTE