Method Reference #
Method title:
Principle of the method:
Parameter
Method Performance
Please report
in units as stated in SMPR!
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 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
myo-inositol
0.175 mg/100g reconstituted final product
<0.14 mg/100 g reconstituted final product
myo-inositol
0.5 mg/100g reconstituted final product
<0.14 mg/100 g reconstituted final product
Spike recovery
90-105%
See Table 1
Bias vs SRM
See Table 2
2, 20, 68 mg/100g reconstituted final product: ≤5%
See Table 3
No SMPR requirements
2, 20, 40, 55, 68 mg/100g reconstituted final product: ≤8% See Table 4
Analytical equipment
Proprietary equipment
Laboratory safety
Other Considerations
0
move to Final Action/repeal/remove/expand 2 year term
b
Units
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
Analytical equipment is commonly available in most labs.
No unique proprietary equipment/accessories are required.
Evaluation of Method Performance vs. SMPR requirements.
2011.18
Determination of Myo-Inositol (Free and Bound as
Phosphatidylinositol) in Infant Formula and Adult Nutritionals
by Liquid Chromatography/Pulsed Amperometry with
Column Switching
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
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.
Feedback from Users of the Method since being
awarded First Action
Official Methods
Status
Repeatability (RSDr)
Reproducibility (RSDR)
Accuracy/Recovery
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.
SMPR Requirement
Analytical Range.
Adequate proof of performance via system suitability
Limit of detection (LOQ)
AOAC SMPR: 2011.007
Notes
Overall Score
See Comments Tab
Intermediate Reproducibility
(RSDiR)
Recommendation ERP 2 years
after First Action Status
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents.
Limit of detection (LOD)
SPIFAN ERP Checklist v 1.5
21.02.2013
