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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 11 SPIFAN matrices met precision and

accuracy requirements for both choline and

carnitine.

1

All analytes defined in the

applicability statement are

measured.

Determination of suppl. and endogenous L-carnitine.

Methods must be able to determine free and total

carnitine... free and bound forms of choline.

Method determines free and total choline and

free and total L-carnitine (acetyl carnitine is

specifically targeted)

1

Total Choline

2-250 mg choline ion/100g RTF

4- 51 was the range of the materials tested

Total Carnitine

0.16 - 20 mg carnitine/100g RTF

0.9-22 was the range encountered

Choline

0.7 mg choline ion/100g RTF

Proven at same limit (see Table 5)

Carnitine

0.05 mg carnitine/100g RTF (implied)

Proven at same limit (see Table 5)

Analyte 3

Analyte 4

Analyte 5

Choline

2.0 mg choline ion/100g RTF

Proven at same limit (see Table 5)

Carnitine

0.16 mg carnitine/100g RTF

Proven at same limit (see Table 5)

Analyte 3

Analyte 4

Analyte 5

Spike recovery (%)

90-110 % mean spiked recovery over the Range (both

choline and carnitine)

choline avg. = 98%, low 90.5%

carnitine avg = 98%, low 95%

acetylcarn avg = 96%, low 90%

2

Bias vs SRM

not stated; note confusion on carnitine certificate

94.2% of choline ion certified mean

110.3% of "free" carnitine certified (by MW)

3

Free Choline

< 10% (2-20); < 5% (20-250)

average 1.3%, high 2.0%

Free Carnitine

< 8%

average 1.5%, high 2.0%

Total Choline

< 10% (2-20); < 5% (20-250)

average 1.3%, high 2.3%

Total Carnitine

< 8%

average 1.2%, high 1.7%

Free Choline

not stated

average 2.2%, high 5.4%

Free Carnitine

not stated

average 2.3%, high 3.8%

Total Choline

not stated

average 1.9%, high 3.0%

Total Carnitine

not stated

average 1.8%, high 2.2%

Choline

< 15% (2-20); < 10% (20-250)

not tested

Carnitine

< 15%

not tested

b

Units

Limit of quantification (LOQ)

Method Reference #

CARN-05

Method title:

Principle of the method:

Carnitine/Choline by LC-MS/MS

Free (dilution) and/or total choline and carnitine (microwave prep) by LC-MS/MS with stable isotope IS

Notes:

Overall Score

Intermediate Reproducibility

(RSDiR)

Recommendation of ERP

2 years after First Action Status

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

SMPR Requirement

Analytical Range.

1

AOAC SMPR: 2012.010

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

Laboratory safety

Other Considerations

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.

3

1

2

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.

SPIFAN ERP Checklist v 1.6

27.06.2013

Carn-05 MEF Form

FOR ERP USE ONLY

DO NOT DISTRIBUTE