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1、DISODIUMETHYLENEDIAMINETETRAACETATEPreparedatthe17thJECFA(1973),publishedinFNP4(1978)andFNP52(1992).Metalsandarsenicspecificationsrevisedatthe61stJECFA(2003).AnADIof0-2.5mg/kgbwwasestablishedatthe17thJECFA(1973)SYNONYMSDisodiumEDTA,disodiumedetate;INSNo.386DEFINITIONChemic
2、alnamesDisodiumsaltofN,N'-1,2-Ethanediylbis[N-(carboxymethyl)glycine];disodiumdihydrogenethylenediaminetetraacetate;disodiumdihydrogen(ethylene-dinitrilo)-tetraacetateC.A.S.number139-33-3ChemicalformulaC10H14N2Na2O8·2H2OStructuralformulaFormulaweight372.24AssayNotlessthan9
3、9%DESCRIPTIONWhite,odourlesscrystallinegranulesorawhitetonearlywhitepowderFUNCTIONALUSESSequestrant,antioxidantsynergist,preservativeCHARACTERISTICSIDENTIFICATIONSolubility(Vol.4)Freelysolubleinwater,practicallyinsolubleinethanolInfraredabsorptionTheinfraredspectrumofthesa
4、mplecorrespondswiththatofareferencestandard(aReferencestandardmaybeobtainedfromtheU.S.Pharmacopeia,12601TwinBrookParkway,Rockville,Maryland20852)Testforsodium(Vol.4)PassestestChelatingactivitytometalTo5mlofwaterinatesttubeadd2dropsofammoniumtothiocyanateTSionsand2dropsoffe
5、rricchlorideTS.Adeepredsolutiondevelops.Addabout50mgofthesampleandmix.Thedeepredcolourdisappears.PURITYpH(Vol.4)4.3-4.7(1in100soln)NitrilotriaceticacidPassestestSeedescriptionunderTESTSLead(Vol.4)Notmorethan2mg/kgDetermineusinganatomicabsorptiontechniqueappropriatetothespe
6、cifiedlevel.TheselectionofsamplesizeandmethodofsamplepreparationmaybebasedontheprinciplesofthemethoddescribedinVolume4,“InstrumentalMethods.”TESTSPURITYTESTSNitrilotriaceticacidStocktestsolutionTransfer10gofthesampleintoa100-mlvolumetricflask,dissolvein40mlofa(1in10)potass
7、iumhydroxidesolution,dilutetovolumewithwater,andmix.DilutedstocktestsolutionPipette10mlofthe"stocktestsolution"intoa100-mlvolumetricflask,dilutetovolumewithwater,andmix.TestpreparationPipette20mlofthe"dilutedstocktestsolution"intoa150-mlbeaker,add1mlofa(1in10)potassiumhydr
8、oxidesolution,2mlofa(1in10)ammoniumnitratesolution,andabout50mgoferiochromeblackTindicato
