吐温80英国药典英文.doc

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1、enan111，密码1988342、消癌平注射液中吐温-80用量的研究及质量控制 2.1建立消癌平注射液中吐温-80含量的测定方法 2.2建立吐温-80纯度的测定方法 2.3不同厂家不同纯度的吐温-80增容效果及安全性评价 1、消癌平注射液中高分子杂质去除方法研究 1.1建立GPC法测定消癌平注射液中高分子物质的方法 1.2超滤前后高分子物质的去除效果研究Polysorbate80Polyoxyethylene20SorbitanMono-oleate (PhEurmonograph0428) 9005-65-6 PhEur  DEFINITION Po

2、lysorbate80isamixtureofpartialestersofvariousfattyacids,mainlyoleicacid,andsorbitolanditsanhydridescopolymerisedwithapproximately20molesofethyleneoxideforeachmoleofsorbitolandsorbitolanhydrides.Thefattyacidfractioncanbeofvegetableoranimalorigin.Itcontainsnotlessthan60.0percentofo

3、leicacidandnotlessthan90.0percentandnotmorethan110.0percentofthecontentstatedonthelabel. PRODUCTION 2-Chloroethanol,ethyleneglycolanddiethyleneglycol Notmorethan10ppmof2-chloroethanolandnotmorethanatotalof0.25percentforethyleneglycolanddiethyleneglycol,determinedbyhead-spacegasch

4、romatography(2.2.28),usingthemethodofstandardadditions. Testsolution Place50mgofthesubstancetobeexaminedina20mlvial,add2.0mlof2-propanolRandcloseimmediately.Allowtostandforabout2minandinanycasenotmorethan5min. Referencesolution Place50mgofthesubstancetobeexaminedina20mlvial,add2.

5、0mlofasolutioncontaining,in2-propanolR,0.25mg/mlof2-chloroethanolR,31.25mg/mlofethyleneglycolRand31.25mg/mlofdiethyleneglycolRandcloseimmediately.Allowtostandforabout2minandinanycasenotmorethan5min. Thechromatographicproceduremaybecarriedoutusing: apurgeandtrapheadspacesampler,as

6、sembledbeforethechromatographicsystemusingastainlesssteelprecolumn13.6mmlongand4mmininternaldiameterpackedwithethylvinylbenzene-divinylbenzenecopolymerRastrapcolumnandheliumforchromatographyRasthecarriergasataflowrateof20ml/minandanadditional20ml/minasauxiliarygas.Placethevialsse

7、paratelyonawater-bathat110Candbeginpurgingwithin5min,whilstmaintainingthetrapcolumnat50C;continuepurgingfor40min.Thenraisethetemperatureofthetrapcolumnto210Candinjectfor5mininthechromatographicsystem, afused-silicacolumn30mlongand0.53mmininternaldiameter,theinternalwallofwhichisc

8、oatedwithmacrogol20000forchromatographyR