葡萄糖注射液檢驗(yàn)方法

GlucoseIntravenousInfusion葡萄糖靜脈輸液GeneralNoticesGlucoseInjectionDEFINITION定義GlucoseIntravenousInfusionisasterilesolutionofAnhydrousGlucoseorGlucose

inWaterforInjections.葡萄糖靜脈輸液是無水葡萄糖或葡萄糖溶于注射用水的無菌溶液。TheintravenousinfusioncomplieswiththerequirementsstatedunderParenteral

Preparationsandwiththefollowingrequirements.該靜脈輸液應(yīng)符合非腸道制劑下的要求和下列要求。Contentofglucose,C6H12O695.0to105.0%ofthestatedamount.葡萄糖的含量,C6H12O6應(yīng)為標(biāo)示量的95.0--105.0%.CHARACTERISTICSAcolourlesssolution.Solutionscontainingtheequivalentof200gperlitreormoreof

glucose,C6H12O6,maybenotmorethanfaintlystrawcoloured.性狀無色溶液。每ml含200g或更過葡萄糖，C6H12O6,的溶液，顏色可以不超過淺黃色。IDENTIFICATION鑒別A.Heatwithcupri-tartaricsolutionR1.Aredprecipitateisproduced.B.ThesolutionpreparedasdirectedintheAssayisdextrorotatory.A.當(dāng)與酒石酸銅溶液R1加熱,產(chǎn)生紅色沉淀。B.含量下制備的溶液呈右旋性。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,附錄VL,必要時(shí)，溶液用注射用水稀釋成5%w/v的葡萄糖溶液，并在溶液中按每100ml加入0.30ml飽和氯化鉀溶液。5-HydroxymethylfurfuralandrelatedsubstancesDiluteavolumecontainingtheequivalentof1.0gofglucose,C6H12O6,to250mlwith

water.Theabsorbanceoftheresultingsolutionatthemaximumat284nmisnot

morethan0.25,AppendixIIB.5-羥甲基糠醛和有關(guān)物質(zhì)將含1.0g葡萄糖,C6H12O6,的供試品用水稀釋至250ml，在最大吸收284nm測(cè)溶液的吸光度,

附錄IIB.吸光度應(yīng)不超過0.25.BacterialendotoxinsTheendotoxinlimitconcentrationis0.25IUperml,AppendixXIVC.Diluteinfusionscontainingmorethan5%w/v(50gperlitre)ofGlucosewithwaterBETtocontain5%w/v.細(xì)菌內(nèi)毒素內(nèi)毒素的限值為0.25IU/ml,附錄XIVC。將濃度大于5%w/v（50g/l）葡萄糖的輸液用BET水稀釋成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,的供試品中加入0.2ml的5M氨水并加水至100ml.充分混合,靜置30分鐘，用2-dm管測(cè)旋光度，附錄VF.所得旋光度的度數(shù)乘以0.9477即為所取體積的注射液中葡萄糖的重量，C6H12O6,g。LABELLINGThestrengthisstatedastheequivalentnumberofgramsofglucose,C6H12O6,per

litre.WhenGlucoseIntravenousInfusionisrequiredasadiluentforInjectionsor

IntravenousInfusionsofthePharmacopoe