AOAC Guidelines for Single Laboratory Validation of Chemical Methods for Dietary 完整版 超高清.pdfVIP

AOACGuidelinesforSingleLaboratory

ValidationofChemicalMethodsforDietary

SupplementsandBotanicals

CONTENTS

1.0Introduction

1.1Definitions

1.1.1Validation

1.1.2Methodofanalysis

1.1.3Performancecharacteristicsofamethodofanalysis

2.0Single-LaboratoryValidationWork

2.1PreparationoftheLaboratorySample

2.2Identification

2.3MethodofAnalysisorProtocol

2.3.1Optimization

2.3.2Referencestandard

2.3.3RuggednessTrial

2.3.4Specificvariables

a.Analyteaddition

b.Reextractionoftheextractedresidue

c.Comparisonwithdifferentsolvents

d.Comparisonwithresultsfromadifferentprocedure

e.SystemSuitabilityChecks

3.0PerformanceCharacteristics

3.1Applicability

3.2Selectivity

3.3Calibration

3.3.1ExternalStandardMethod

3.3.2InternalStandardMethod

3.3.3StandardAdditionMethod

3.4ReliabilityCharacteristics

3.4.1Accuracy

3.4.2RepeatabilityPrecision(sr,RSDr)

3.4.3MeasurementUncertainty

3.4.4ReproducibilityPrecision(sR,RSDR)

3.4.5IntermediatePrecision

3.4.6LimitofDetermination

3.4.7ReportingLow-levelValues

3.4.8DichotomousReporting

3.5Controls

3.5.1ControlCharts

3.5.2InjectionControls

3.5.3DuplicateControls

3.6ConfirmationofAnalyte

12002-12-19

4.0Report(asapplicable)

Identity,source,purityofreferencematerial

Scope,applicability,nonapplicability

Recovery,levels,percent(n=5ateachconcentrationlevel)

Repeatability,RSDr(n=5ateachconcentrationlevel)

Intermediateprecision,RSDi(n=5ateachconcentrationlevel)

Limitofdetermination