葡萄糖注射液检验方法

GlucoseIntravenousInfusion葡萄糖静脉输液GeneralNoticesGlucoseInjectionDEFINITION定义GlucoseIntravenousInfusionisasterilesolutionofAnhydrousGlucoseorGlucose

inWaterforInjections.葡萄糖静脉输液是无水葡萄糖或葡萄糖溶于注射用水的无菌溶液。TheintravenousinfusioncomplieswiththerequirementsstatedunderParenteral

Preparationsandwiththefollowingrequirements.该静脉输液应符合非肠道制剂下的要求和下列要求。Contentofglucose,C6H12O695.0to105.0%ofthestatedamount.葡萄糖的含量,C6H12O6应为标示量的95.0--105.0%.CHARACTERISTICSAcolourlesssolution.Solutionscontainingtheequivalentof200gperlitreormoreof

glucose,C6H12O6,maybenotmorethanfaintlystrawcoloured.性状无色溶液。每ml含200g或更过葡萄糖，C6H12O6,的溶液，颜色可以不超过浅黄色。IDENTIFICATION鉴别A.Heatwithcupri-tartaricsolutionR1.Aredprecipitateisproduced.B.ThesolutionpreparedasdirectedintheAssayisdextrorotatory.A.当与酒石酸铜溶液R1加热,产生红色沉淀。B.含量下制备的溶液呈右旋性。TESTSAciditypH,3.5to6.5,AppendixVL,whendeterminedonasolutiondiluted,ifnecessary,

withwaterforinjections,tocontainnotmorethantheequivalentof5%w/vofglucose,C6H12O6,andtowhich0.30mlofasaturatedsolutionofpotassiumchloride

hasbeenaddedforeach100mlofsolution.酸度溶液的pH,3.5--6.5,附录VL,必要时，溶液用注射用水稀释成5%w/v的葡萄糖溶液，并在溶液中按每100ml加入0.30ml饱和氯化钾溶液。5-HydroxymethylfurfuralandrelatedsubstancesDiluteavolumecontainingtheequivalentof1.0gofglucose,C6H12O6,to250mlwith

water.Theabsorbanceoftheresultingsolutionatthemaximumat284nmisnot

morethan0.25,AppendixIIB.5-羟甲基糠醛和有关物质将含1.0g葡萄糖,C6H12O6,的供试品用水稀释至250ml，在最大吸收284nm测溶液的吸光度,

附录IIB.吸光度应不超过0.25.BacterialendotoxinsTheendotoxinlimitconcentrationis0.25IUperml,AppendixXIVC.Diluteinfusionscontainingmorethan5%w/v(50gperlitre)ofGlucosewithwaterBETtocontain5%w/v.细菌内毒素内毒素的限值为0.25IU/ml,附录XIVC。将浓度大于5%w/v（50g/l）葡萄糖的输液用BET水稀释成5%w/v。ASSAYToavolumecontainingtheequivalentof2gto5gofglucose,C6H12O6,add0.2mlof

5Mammoniaandsufficientwatertoproduce100ml.Mixwell,allowtostandfor30

minutesanddeterminetheopticalrotationina2-dmtube,AppendixVF.Theobservedrotationindegreesmultipliedby0.9477representstheweightingof

glucose,C6H12O6,inthevolumetakenforassay.向含2--5g葡萄糖,C6H12O6,的供试品中加入0.2ml的5M氨水并加水至100ml.充分混合,静置30分钟，用2-dm管测旋光度，附录VF.所得旋光度的度数乘以0.9477即为所取体积的注射液中葡萄糖的重量，C6H12O6,g。LABELLINGThestrengthisstatedastheequivalentnumberofgramsofglucose,C6H12O6,per

litre.WhenGlucoseIntravenousInfusionisrequiredasadiluentforInjectionsor

IntravenousInfusionsofthePharmacopoe