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EUROPEANPHARMACOPOEIA7.0Xylitol—mobilephaseB:methanolR,acetonitrileR(30:70V/V);IMPURITIESSpecifiedimpurities:A,B,C,D,E.TimeMobilephaseAMobilephaseB(min)(percentV/V)(percentV/V)0-1589→2811→7215-212872Flowrate:1.0mL/min.A.2,6-dimethylaniline(2,6-xylidine),Detection:spectrophotometerat230nm.Equilibration:withamixtureof28volumesofmobilephaseAand72volumesofmobilephaseBforatleast30min.Injection:20μL.B.N,N′-bis(2,6-dimethylphenyl)thiourea,Identificationofimpurities:usethechromatogramsuppliedwithxylazineimpuritymixtureCRSandthechromatogramobtainedwithreferencesolution(b)toidentifythepeaksduetoimpuritiesBandD;usethechromatogramobtainedwithreferencesolution(a)toidentifythepeaksduetoimpuritiesA,CandE.C.2,6-dimethylphenylisothiocyanate,Relativeretentionwithreferencetoxylazine(retentiontime=about7.5min):impurityD=about0.5;impurityA=about0.8;impurityB=about1.3;impurityE=about1.6;impurityC=about2.2.Systemsuitability:referencesolution(a):D.N-(2,6-dimethylphenyl)-N′-(3-hydroxypropyl)thiourea,—resolution:minimum4.0betweenthepeaksduetoimpurityAandxylazine.Limits:—impuritiesB,D:foreachimpurity,notmorethantwiceE.methyl(2,6-dimethylphenyl)carbamodithioate.theareaofthepeakduetoxylazineinthechromatogramobtainedwithreferencesolution(a)(0.2percent);01/2009:1381—impuritiesC,E:foreachimpurity,notmorethantwicetheareaofthecorrespondingpeakinthechromatogramXYLITOLobtainedwithreferencesolution(a)(0.2percent);—unspecifiedimpurities:foreachimpurity,notmoreXylitolumthantwicetheareaofthepeakduetoxylazineinthechromatogramobtainedwithreferencesolution(a)(0.2percent);—totalofimpuritiesotherthanB,C,DandE:notmorethantwicetheareaofthepeakduetoxylazineinthechromatogramobtainedwithreferencesolution(a)(0.2perC5H12O5Mr152.1cent);[87-99-0]—disregardlimit:0.5timestheareaofthepeakduetoxylazineDEFINITIONinthechromatogramobtainedwithreferencesolution(a)Meso-xylitol.(0.05percent);disregardanypeakduetotheblank.Content:98.0percentto102.0percent(anhydroussubstance).Heavyme
