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1、EUROPEANPHARMACOPOEIA7.0OxytocinRelatedsubstances.Liquidchromatography(2.2.29):usethenormalisationprocedure.Testsolution.Preparea0.25mg/mLsolutionofthesubstancetobeexaminedina15.6g/LsolutionofsodiumdihydrogenphosphateR.Resolutionsolution.DissolvethecontentsofavialofF.(4S,4aR,5R,12
2、aS)-4-(dimethylamino)-3,5,10,11,oxytocin/desmopressinvalidationmixtureCRSin1mLofa12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,15.6g/LsolutionofsodiumdihydrogenphosphateR.5,12,12a-hexahydrotetracene-2-carboxamideColumn:(anhydro-oxytetracycline).—size:l=0.125m,Ø=4.6mm;—stationaryphas
3、e:octadecylsilylsilicagelforchromatographyR(5μm).Mobilephase:01/2008:0780corrected6.0—mobilephaseA:15.6g/LsolutionofsodiumdihydrogenphosphateR;OXYTOCIN—mobilephaseB:acetonitrileforchromatographyR,waterR(50:50V/V);TimeMobilephaseAMobilephaseBOxytocinum(min)(percentV/V)(percentV/V)0
4、-3070→4030→6030-30.140→7060→30C43H66N12O12S2Mr100730.1-457030[50-56-6]Flowrate:1mL/min.DEFINITIONDetection:spectrophotometerat220nm.L-Cysteinyl-L-tyrosyl-L-isoleucyl-L-glutamyl-L-asparaginyl-L-Injection:50μL.cysteinyl-L-prolyl-L-leucylglycinamidecyclic(1→6)-disulfide.Retentiontime
5、:oxytocin=about7.5min;desmopressin=aboutSyntheticcyclicnonapeptidehavingthestructureofthe10min.hormoneproducedbytheposteriorlobeofthepituitaryglandthatstimulatescontractionoftheuterusandmilkejectioninSystemsuitability:resolutionsolution:receptivemammals.Itisavailableinthefreeze-dr
6、iedformas—resolution:minimum5.0betweenthepeaksduetoanacetate.desmopressinandoxytocin.Content:93.0percentto102.0percent(anhydrousandaceticLimits:acid-freesubstance).—anyimpurity:maximum1.5percent;Byconvention,forthepurposeoflabellingoxytocin—total:maximum5percent;preparations,1mgof
7、oxytocinpeptide(CHNOS)is436612122—disregardlimit:0.1percent.equivalentto600IUofbiologicalactivity.Aceticacid(2.5.34):6.0percentto10.0percent.CHARACTERSTestsolution.Dissolve15.0mgofthesubstancetobeexaminedAppearance:whiteoralmostwhite,hygroscopicpowder.inamixtureof5volumesofmobilep
8、haseBand95volumesofmobilephaseAan
