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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 fromdrop-down list,5=best)
SPIFANmatrices
Applicable toall formsof infant,adult,and/orpediatric formula
(powders, ready-to-feed liquids,and liquid concentrates).
Any combinationofmilk, soy, rice,whey,hydrolyzedprotein, starch,and
aminoacids,withandwithout intactprotein.
1
Allanalytesdefined in the
applicability statementare
measured.
1
0.4 -2500
0.18 -300
Analyte1
Analyte2
Analyte3
Analyte4
Analyte5
Analyte1
0.4mg/100g
0.18mg/100g
Analyte2
Analyte3
Analyte4
Analyte5
Spike recovery (%)
95% -105%
100.5% -101.8%
2
Bias vs SRM
2.7
3
<2%
1.00%
2.30%
b
Units
Biasagainstestablishedmethod
Analyticalequipment
1
Adequateproofofperformancevia system suitability
Is thereabiasYes/No?
Analyticalequipment is commonlyavailable inmost labs.
2
move toFinalAction/repeal/remove/expand2 year term
0
Nouniqueproprietaryequipment/accessoriesare required.
Methoddoesnot requireany special safetyprecautionse.g.personalprotection fromhighly toxic solvents.
3
1
AOAC SMPR: …………..
Limitofdetection (LOD)
1
a
Concentrationsapply to (1) "ready to feed liquids" "as-is"; (2) reconstitutedpowders (25g into200gwater);and (3) liquid concentratesdiluted1:1byweight.
DidMethodAuthorConsiderERP’sMethodSpecific
Recommendations
(Seeweb link to specificmethod
comments):
Decision by ERP
Proprietaryequipment
Evaluation of Method Performance vs. SMPR requirements.
Feedback fromUsersof theMethod sincebeingawarded
FirstAction
OfficialMethods
Status
Repeatability (RSDr)
Reproducibility (RSDR)
Accuracy/Recovery
ADDITIONAL EVALUATION PARAMETERS
Notes:
Overall Score
IntermediateReproducibility
(RSDiR)
Recommendation of ERP
2 years after First Action Status
Laboratory safety
OtherConsiderations
Limitofquantification (LOQ)
Method Reference #
AMINO-02
Method title:
Principle of the method:
Amino-02- HPLC Determination of Total Tryptophan in Infant Formula and Adult/Pediatric Nutritional Formula Following Enzymatic Hydrolysis
SMPR Requirement
AnalyticalRange.
1
SPIFANERPChecklist v1.6
27.06.2013
AMINO-02 (FEBRUARY 2017) - MEF FORM
FOR ERP USE ONLY
DO NOT DISTRIBUTE
20