氨基葡萄糖硫酸钠盐USP32标准

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1、氨基葡萄糖硫酸钠盐USP32标准GlucosamineSulfateSodiumChloride(C6H14NO5)2SO42NaCl573.31Bis(d-Glucose,2-amino-2-deoxy-),sulfatesodiumchloridecomplex.Bis(2-Amino-2-deoxy-d-glucopyranose)sulfatesodiumchloridecomplex(-,-)38899-05-7.GlucosamineSulfateSodiumChloridecontainsnotlessthan98.0percentandnotmorethan102.0perce

2、ntof(C6H14NO5)2SO42NaClcalculatedonthedriedbasis.PackagingandstoragePreserveintight,light-resistantcontainers.USPReferencestandards11USPGlucosamineHydrochlorideRS.IdentificationA:InfraredAbsorption197K.TestsolutionTransferabout50mgofGlucosamineSulfateSodiumChloridetoacentrifugetube,anddissolvein2mLo

3、fwater.Addabout0.5mLofbariumchlorideTS,andcentrifuge.Evaporatethesupernatant,anddrytheresidueat105for2hours.TheIRspectrumcorrespondstothatofasimilarpreparationofUSPGlucosamineHydrochlorideRS,exceptthattheadditionofbariumchlorideTSisomitted.B:ItmeetstherequirementsofthetestsforChloride191andSodium191

4、.C:TheretentiontimeofthemajorpeakinthechromatogramoftheAssaypreparationcorrespondstothatinthechromatogramoftheStandardpreparation,asobtainedintheAssay.D:InthetestfortheContentofsulfate,aftertheadditionofbariumchlorideTS,awhiteprecipitateisformed.Specificrotation781S:between+50.0and+55.0.Testsolution

5、:35mgpermL.Measurethespecificrotation3hoursaftersamplepreparation.pH791:between3.0and5.0,inasolutioncontaining20mgpermL.Lossondrying731Dryitat105for2hours:itlosesnotmorethan1.0%ofitsweight.Residueonignition281:between22.5%and26.0%.PotassiumAcidify5mLofasolution(1in20)with6Naceticacid,andadd5dropsofs

6、odiumcobaltinitriteTS:noprecipitateisformed.Arsenic,MethodII211:3gperg.Heavymetals,MethodII231:0.001%.ContentofsulfateTransferabout1gofGlucosamineSulfateSodiumChloride,accuratelyweighed,toa250-mLbeaker,anddissolveinabout100mLofwater.Add4mLof6Nhydrochloricacid.Heatthesolutiontoboiling, andadd,withcon

7、stantstirring,sufficientboilingbariumchlorideTStocompletelyprecipitatethesulfate.Addanadditional2mLofbariumchlorideTS,anddigestonasteambathfor1hour.Passthemixturethroughashlessfilterpaper,transferringtheresiduequantitativelytothefilter,andwashtheresiduewithhotwateruntilnoprecipitateisobtainedwhen1mL

8、ofsilvernitrateTSisaddedto5mLofwashing.Transferthepapercontainingtheresiduetoataredcrucible.Charthepaper,withoutburning,andignitethecrucibleanditscontentstoconstantweight.Calculatethecontentofsulfatebymultiplyingtheweightobtainedby0.4116.Thecontentofsulfateisbetween16.3%and17.3%.AssayPhosphatebuffer

9、,Mobilephase,Standardpreparation,andChromatographicsystemProceedasdirectedintheAssayunderGlucosamineHydrochloride.AssaypreparationTransferabout100mgofGlucosamineSulfateSodiumChloride,accuratelyweighed,toa100-mLvolumetricflask.Dissolvein30mLofwater,shakebymechanicalmeans,dilutewithwatertovolume,andmi

10、x.ProcedureProceedasdirectedintheAssayunderGlucosamineHydrochloride.Calculatethepercentageof(C6H14NO5)2SO42NaClintheportionofGlucosamineSulfateSodiumChloridetakenbytheformula:10,000(573.31/431.26)(C/W)(rU/rS)inwhich573.31isthemolecularweightoftheglucosaminesulfatesodiumchlorideand431.26istwicethemol

11、ecularweightofglucosamineHCl;Wistheweight,inmg,ofGlucosamineSulfateSodiumChlorideusedtopreparetheAssaypreparation;andtheotherstermsareasdefinedtherein.AuxiliaryInformationPleasecheckforyourquestionintheFAQsbeforecontactingUSP.Topic/QuestionContactExpertCommitteeMonographCurtisPhinney1-301-816-8540(D

12、SN05)DietarySupplements-Non-BotanicalsReferenceStandardsLiliWang,TechnicalServicesScientist1-301-816-8129USP32NF27Page1031PharmacopeialForum:VolumeNo.33(4)Page692ChromatographicColumnGLUCOSAMINESULFATESODIUMCHLORIDEChromatographiccolumnstextisnotderivedfrom,andnotpartof,USP32orNF27分子式：(C6H14NO5)2SO4

13、2NaCl分子量：573.31CAS:38899-05-7性状：白色结晶性粉末来源：蟹、虾等的壳。用途：医药上：可治疗口内炎、化脓性湿疹、关节炎、毒蛇咬伤等临床功能。日用品上：作为化妆品中美容膏、洗发剂添加剂可以优化肌肤，起到抗氧化功效。农业上：可用于植物生长调节、植物活性剂。氨基葡萄糖硫酸盐及其复盐为抗风湿性关节炎的原料药，近年发现有吸收自由基、抗衰老、减肥、调节内分泌等多种有益的生理作用。故被广泛用于食品添加剂和保健食品的生产中。检验项目标准规格外观白色或类白色结晶性粉末。含量（按折干计）98.0%102.0%炽灼残渣22.5%26.0%硫酸盐16.3%17.3%砷不得大于1 ppm重金属

14、不得大于10ppm检查比旋度+50.0+55.0pH3.05.0干燥失重不得大于0.5%微生物限度细菌总数不超过1000cfu/g。霉菌和酵母菌数不超过100cfu/g。控制菌大肠埃希菌不得检出。沙门氏菌不得检出金黄色葡萄糖球菌不得检出杂质2铅不得大于0.5 ppm汞不得大于0.5 ppm镉不得大于0.5 ppm包装：纸板桶（330mm380mm）内衬两层聚乙烯薄膜塑料袋25.0kg包装，或按用户要求。储运：储存于干燥、清洁、阴凉处。运输时轻装轻卸，不得与有害、有毒和易污染物品混合装运，严禁淋雨。项目标准 （美国药典版）性状白色结晶性粉末比旋度+52+54pH值3.004.50铁离子10PPM重金属10PPM干燥失重1.00%含量98.0%-102.0%（以干基计）灼烧残渣23.525.0%氯化物14.00%硫酸盐16.3%-17.3%有机挥发杂质符合要求微生物检验细菌总数酵母、霉菌沙门氏菌大肠杆菌不大于500/g不大于100/g不得检出不得检出包装和储存保存在密封闭光的容器内有效期两年