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1、羧甲基淀粉钠美国药典30版标准SodiumStarchGlycolateStarchcarboxymethylether,sodiumsalt.»SodiumStarchGlycolateisthesodiumsaltofacarboxymethyletherofstarchorofacross-linkedcarboxymethyletherofstarch.Itmaycontainnotmorethan7.0percentofSodiumChloride.ThepHandassayrequirementsforTypeAandTypeBarese
2、tfoHThintheaccompanyingtable。Packagingandstorage—Preserveinwell-closedcontainers,preferablyprotectedfromwidevariationsintemperatureandhumidity,whichmaycausecaking.Labeling—Labelittoindicatethebotanicalsourceofthestarchfromwhichitwasderived,thecross-linkingagent(ifused),thepHran
3、ge,andwhetheritisTypeAorTypeB.USPReferencestandards11—USPSodiumStarchGlycolateTypeARS.USPSodiumStarchGlycolateTypeBRS.Identification—A:InfraredAbsorption197K.B:AslightlyacidifiedsolutionofitiscoloredbluetovioletbytheadditionofiodineandpotassiumiodideTS1.C:Toa2-mLpoHTionofthesol
4、utionpreparedforthetestforLimitofiron,add4mLofPotassiumpyroantimonatesolution.Ifnecessary,rubtheinsideofthetesttubewithaglassrod.Awhite,crystallineprecipitateisformed.Potassiumpyroantimonatesolution—To2gofpotassiumpyroantimonateadd100mLofwater.Boilthesolutionforabout5minutes,co
5、olquickly,andadd10mLofasolutionofpotassiumhydroxide(3in20).Allowtostandfor24hours,andfilter.D:SodiumStarchGlycolateimpaHTsanintenseyellowcolortoanonluminousflame.Microbiallimits61—ItmeetstherequirementsofthetestsforabsenceofSalmonellaspeciesandEscherichiacoli.pH791—Disperse1gin
6、30mLofwater.ThepHoftheresultingsuspensioniseitherbetween5.5and7.5forTypeAorbetween3.0and5.0forTypeB.Lossondrying731—Dryitat130for90minutes:itlosesnotmorethan10.0%ofitsweight.Heavymetals,MethodII231:0.002%.Limitofiron—Standardsolution—Dissolve863.4mgofferricammoniumsulfate[FeNH4
7、(SO4)2·12H2O]inwater,add25mLof2Nsulfuricacid,dilutewithwaterto500.0mL,andmix.Pipet10mLofthissolutionintoa100-mLvolumetricflask,dilutewithwatertovolume,andmix.Pipet5mLofthissolutionintoa100-mLvolumetricflask,dilutewithwatertovolume,andmix.Thissolutioncontainstheequivalentof1.0μg
8、ofironpermL.Testsolution—[NOTE—ReserveapoHTionofthisso
