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1、Search:correctionfactorAppendixIIIChromatographicSeparationTechniques(Ph.Eur.method2.2.46)Chromatographicseparationtechniquesaremulti-stageseparationmethodsinwhichthecomponentsofasamplearedistributedbetween2phases,oneofwhichisstationary,whiletheotherismobile.T
2、hestationaryphasemaybeasolidoraliquidsupportedonasolidoragel.Thestationaryphasemaybepackedinacolumn,spreadasalayer,ordistributedasafilm,etc.Themobilephasemaybegaseousorliquidorsupercriticalfluid.Theseparationmaybebasedonadsorption,massdistribution(partition),i
3、onexchange,etc.,ormaybebasedondifferencesinthephysico-chemicalpropertiesofthemoleculessuchassize,mass,volume,etc.Thischaptercontainsdefinitionsandcalculationsofcommonparametersandgenerallyapplicablerequirementsforsystemsuitability.Principlesofseparation,appara
4、tusandmethodsaregiveninthefollowinggeneralmethods: —paperchromatography(2.2.26); —thin-layerchromatography(2.2.27); —gaschromatography(2.2.28); —liquidchromatography(2.2.29); —size-exclusionchromatography(2.2.30); —supercriticalfluidchromatography(2.2.45).DEFI
5、NITIONSThesystemsuitabilityandacceptancecriteriainmonographshavebeensetusingparametersasdefinedbelow.Withsomeequipment,certainparameters,suchasthesignal-to-noiseratioandresolution,canbecalculatedusingsoftwareprovidedbythemanufacturer.Itistheresponsibilityofthe
6、usertoensurethatthecalculationmethodsusedinthesoftwareareequivalenttotherequirementsoftheEuropeanPharmacopoeiaandtomakeanynecessarycorrectionsifthisisnotthecase.CHROMATOGRAMAgraphicalorotherrepresentationofdetectorresponse,effluentconcentrationorotherquantityu
7、sedasameasureofeffluentconcentration,versustimeorvolume.IdealisedchromatogramsarerepresentedasasequenceofGaussianpeaksonabaseline(Figure2.2.46.-1).©CrownCopyright20121PEAKTheportionofachromatogramrecordingthedetectorresponsewhenasinglecomponent(or2ormoreunreso
8、lvedcomponents)iselutedfromthecolumn.Thepeakmaybedefinedbythepeakarea,orthepeakheight(h)andthepeakwidthathalf-height(wh),orthepeakheight(h)andthepeakwidthbetweenthepointsofinflecti
