文档介绍：替诺福韦Monographs:Pharmaceuticalsubstances:Tenofoviridisoproxilifumaras-TenofovirdisoproxilfumarateCHNOP,,1'-bis(1-methylethyl)1,1'-[({[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl}phosphonoyldioxy)dimethyl]dicarbonate(ester)hydrogen(2E)-but-2-enedioate(salt);-50--white,,solubleinmethanol,(NucleotideReverseTranscriptaseInhibitor).,protectedfromlight,andstoredatatemperaturebetween2and8?(CHNOP,CHO),,iftested,plywith:-alimitofnotmorethan5ppmforthemutagenicimpurity9-(prop-1-enyl)-9H-purin-6-amine(impurityK),whichmaybeasynthesisrelatedsubstance,usingasuitablemethod,and-%forthetenofovirdisoproxil(S)-enantiomer(impurityG),•EithertestsA,,whereUVdetectionisnotavailable,-layerchromatography,usingsilicagelR6asthecoatingsubstanceandamixtureof67volumesofdichloromethaneR,20volumesofacetonitrileR,10volumesofmethanolRand3volumesofammonia(~260g/l)(A)10mgofthetestsubstancepermland(B),(254nm).TheprincipalspotobtainedwithsolutionAcorrespondsinposition,appearance,andintensitywiththatobtainedwithsolutionB.