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1、CenterforDrugEvaluationandResearch(CDER)ReviewerGuidance'ValidationofChromatographicMethodsNovember1994CMC3TABLEOFCONTENTSI.INTRODUCTION...............................................1II.TYPESOFCHROMATOGRAPHY.................................2A.HighPerformanceLiquidChromatograph
2、y(HPLC)...............21.ChiralChromatography...............................22.Ion-exchangeChromatography.........................33.Ion-pair1AffinityChromatography........................34.NormalPhaseChromatography.........................35.ReversedPhaseChromatography.......
3、................36.SizeExclusionChromatography........................4B.GasChromatography(GC)..................................4C.Thin-LayerChromatography(TLC)............................5Ill.REFERENCESTANDARDS......................................5IV.PARAMETERSFORVALIDATIONOF
4、HPLCHROMATOGRAPHICMETHODSFORDRUGSUBSTANCEANDDRUGPRODUCT..........7A.Accuracy................................................8B.DetectionLimitandQuantitationLimit.........................8C.Linearity................................................11D.Precision...................
5、............................131.Repeatability........................................13a.InjectionRepeatability...........................13b.AnalysisRepeatability...........................152.IntermediatePrecision................................153.Reproducibility............
6、..........................16E.Range..................................................16F.Recovery................................................16G.Robustness..............................................16H.SampleSolutionStability...................................17I.Specifi
7、citylselectivity.......................................17J.SystemSuitabilitySpecificationsandTests.....................211.Capacityfactor.......................................222.Precisionllnjectionrepeatability.........................223.Relativeretention....................
8、................224.Resolution........................
