(6s)-5-甲基四氢叶酸钙-(6s)-5-甲基四氢叶酸钙.pdf

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1、CALCIUML-5-METHYLTETRAHYDROFOLATENewspecificationspreparedatthe65thJECFA(2005)andpublishedinFNP52Add13(2005).Atthe65thJECFA(2005)theCommitteehadnosafetyconcernsfortheuseofthesubstanceindrycrystallineormicroencapsulatedformasanalternativetofolicacidusedindietarysupplements,foodsforspecialdietaryu

2、sesandotherfoods.SYNONYMSL-5-Methyltetrahydrofolicacid,calciumsaltL-Methyltetrahydrofolate,calciumsaltL-Methylfolate,calciumL-5-MTHF-CaDEFINITIONCalciumL-5-methyltetrahydrofolate(L-5-MTHF-Ca)isasyntheticderivativeoffolicacid,thepredominant,naturallyoccurringformoffolate.Itissynthesizedbyreductio

3、noffolicacidtotetrahydrofolicacidfollowedbymethylationanddiastereoselectivecrystallization(inwater)ofL-5-MTHFasitscalciumsalt.Theproductcontainsvariableamountsofwaterofcrystallization.ChemicalnameN-{4-[[((6S)-2-amino-3,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-gluta

4、micacid,calciumsaltC.A.S.number151533-22-1ChemicalformulaC20H23CaN7O6(anhydrousform)Structuralformula(anhydrousform)OOH-Oα2+NCaH-OOCH3HNNOHN6HH2NNNHFormulaweight497.5(anhydrousform)Assay95.0–102.0%(anhydrousbasis)DESCRIPTIONWhitetolightyellowish,almostodourless,crystallinepowderFUNCTIONALUSESNut

5、rientsupplementCHARACTERISTICSIDENTIFICATIONSolubility(Vol.4)Sparinglysolubleinwaterandveryslightlysolubleorinsolubleinmostorganicsolvents;solubleinalkalinesolutionsInfraredabsorptionTheinfraredabsorptionspectrumofapotassiumbromidedispersionofthesamplecorrespondstothatofaL-5-MTHF-Castandard(seeA

6、ppendix).CalciumDilute30gofaceticacid(glacial)to100mlwithwater.Dissolve5.3gofK4Fe(CN)6in100mlofwater.To5mloftheaceticacidsolution,add20mgofthesampleandthen0.5mlofthepotassiumferrocyanidesolution.Mixandadd50mgofammoniumchloride.Awhitecrystallineprecipitateisformed.LiquidchromatographyRetentiontim

7、ematchesthatofareferencestandard(seeunderTESTS)PURITYWater(Vol.4)Notmorethan17.0%(KarlFischermethod)(Note:Allowsufficienttime(15min)forreleaseofboundwater.)Calcium7.0-8.5%(anhydrousbasis)Accuratelyweigh500mgofsampleandtransf