Amino-01 (July 2018)
Amino‐01 (July 2018) Method Evaluation Form (MEF)
Evaluation of Method Performance vs. SMPR requirements. AOAC SMPR: 2014.013
FOR ERP USE ONLY DO NOT DISTRIBUTE
N/A
Method Reference #
Method title:
Single Laboratory Validation Report for Total Amino Acids by UHPLC‐UV in Infant Formulas and Adult Nutritionals
Principle of the method:
Separation by UHPLC or derivatized amino acids after acid hydrolysis
Weighting factor for parameter
Suitability Ranking (1‐ 3‐5) (select from drop‐down list, 5 = best)
Method Performance Please report in units as stated in SMPR!
SMPR Requirement
Parameter
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. Determination of free and/or total proteinogenic L‐α‐amino acids and taurine
SPIFAN matrices
1
Yes
All analytes defined in the applicability statement are measured.
Method is for total amino acids only. Tryptophan is not included in the scope of this method.
1
The method covers a narrower range (from about 2 to 820 mg/100 g rec.prod., this varies for each analyte), but almost all actual measurements fall within this range. No sample value below lower concentration of the calibration curve. See SLV report and appendices for details.
0.4–2500 mg/100g reconstituted product
Analytical Range.
1
All Analytes
N/A
Limit of detection (LOD)
1
All Analytes
0.4 mg/100 g reconstituted product
2.5 mg/100 g reconstituted product
This LoQ is in line with the actual analyte concentrations measured across the SPIFAN II kit. See the SLV report and appendices for details.
Limit of quantification (LOQ)
2
0.5–5.0: 88‐112% 5.0‐150: 90‐110% 150‐ 2500: 93‐107%
From Table 1, average spike recovery is 99%. See Table 1 as well as SLV report and appendices for detailed results. From Table 2, 14 out of 17 analytes are within the reference range. See Table 2 as well as SLV report and appendices for detailed results. From Table 3, the average repeativility is 1.1%. See Table 3 as well as SLV report and appendices for detailed results.
2
Spike recovery (%)
Accuracy/Recovery
3
Bias vs SRM
same
0.5–5.0: ≤7% 5.0‐150: ≤5% 150‐ 2500: ≤ 3 %
All Analytes
Repeatability (RSDr)
3
From Table 3, the average intermediate reproducibility is 5.0%. See Table 3 as well as SLV report and appendices for detailed results.
All Analytes
Not in the SMPR
Intermediate Reproducibility (RSDiR)
1
0.4–5.0: ≤15% >5.0: ≤10%
All Analytes
Not done in the SLV
Reproducibility (RSDR)
1
ADDITIONAL EVALUATION PARAMETERS
Adequate proof of performance via system suitability
N/A
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
N/A
N/A
Bias against established method
Is there a bias Yes/No ? N/A
Analytical equipment is commonly available in most labs. Waters Acquity systems were used for this SLV but other equipement could in principle be used No unique proprietary equipment/accessories are required. While the method is based on Waters AccQ‐Tag technologiy, we propose alternative reagents that can be used.
Analytical equipment
Proprietary equipment
Method does not require any special safety precautions e.g. personal protection from highly toxic solvents. Hydrolysis in hot hydrocholoric acid, neutralization with NaOH, acetonitrile for separation
Laboratory safety
The SLV report details the results for each analyte/product combination, according to the specific requirements determined by the level of the analyte in the sample.
Other Considerations
0
Overall Score
Decision by ERP
Recommendation of 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 1.6
27.06.2013
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