OMB Meeting Book_9-11-14

Evaluation of Method Performance vs. SMPR requirements.

AOAC SMPR: 2011.007

2011.18

Method Reference #

Determination of Myo-Inositol (Free and Bound as Phosphatidylinositol) in Infant Formula and Adult Nutritionals by Liquid Chromatography/Pulsed Amperometry with Column Switching

Method title:

The liquid chromatography method with electrochemical (pulsed amperometry) detection (PAD) allows for the

quantitation of free myo-inositol and myo-inositol bound as phosphatidylinositol in infant, pediatric, and adult nutritional formulas. The concentration of myo-inositolis calculated by comparison with standards of known

Principle of the method:

concentration. Total myo-inositol, as defined by AOAC standard method performance requirement (SMPR) 2011.007 (1), can be calculated by adding the free myo-inositol and myo-inositol bound as phosphatidylinositol data.

Suitability Ranking (1-3-5) (select from drop- down list, 5 = best)

Method Performance

Please report

SMPR Requirement

Parameter

in units as stated in SMPR!

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.

SPIFAN matrices

All SPIFAN matrices analyzed during SLV.

All required analytes are measured.

Free myo-inositol and phosphatidylinositol only

Method measures all required analytes.

0.5-68 mg/100g reconstituted final product

0.002-2.0 mg/100 mL range of standard curve > 0.5 mg/100g reconstituted final product

Analytical Range.

myo-inositol

<0.14 mg/100 g reconstituted final product

 0.175 mg/100g reconstituted final product

Limit of detection (LOD)

myo-inositol

<0.14 mg/100 g reconstituted final product

 0.5 mg/100g reconstituted final product

Limit of detection (LOQ)

Spike recovery

90-105%

Accuracy/Recovery

See Table 1 See Table 2 See Table 3

Bias vs SRM

2, 20, 68 mg/100g reconstituted final product: ≤5%

Repeatability (RSDr)

No SMPR requirements

Intermediate Reproducibility (RSDiR)

2, 20, 40, 55, 68 mg/100g reconstituted final product: ≤8% See Table 4

Reproducibility (RSDR)

Peak responses of precision injections of the high working standard must have an RSD of ≤ 2.0%. At each working standard concentration, the peak areas of standards injected at the beginning and end of a set of samples should not increase or decrease by more than 7% . A standard curve must have a correlation of at least 0.999 to be considered acceptable for sample calculations. For each set of samples, the control result must be within 3 standard deviations of the control means.

Adequate proof of performance via system suitability

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

See Comments Tab

Analytical equipment is commonly available in most labs.

Analytical equipment

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

Overall Score

0

Decision by ERP

Recommendation 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 1.5

21.02.2013