美国药典(usp34)附录-115英文

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1、115DEXPANTHENOLASSAYThefollowingprocedureisprovidedforthedeterminationofdexpanthenolasaningredientofmultiple-vitaminpreparations.Itisapplicablealsotothedeterminationofthedextrorotatorycomponentofracemicpanthenolandofothermixturescontainingdextrorotatorypanthenol.Mediamay

2、bepreparedasdescribedhereinafter,ordehydratedmixturesyieldingsimilarformulationsmaybeusedprovidedthat,whenreconstitutedasdirectedbythemanufacturerordistributor,theyhavegrowth-promotingpropertiesequaltoorsuperiortothoseobtainedfromtheformulasgivenherein.USPReferenceStanda

3、rds11—USPDexpanthenolRS.StandardStockSolutionofDexpanthenol—DissolveanaccuratelyweighedquantityofUSPDexpanthenolRSinwater,dilutewithwatertoobtainasolutionhavingaknownconcentrationofabout800µgpermL,andmix.Storeinarefrigerator,protectedfromlight,andusewithin30days.Standard

4、Preparation—Onthedayoftheassay,prepareawaterdilutionoftheStandardStockSolutionofDexpanthenoltocontain1.2µgofdexpanthenolpermL.AssayPreparation—Proceedasdirectedintheindividualmonographforpreparingasolutionexpectedtocontainapproximatelytheequivalentofthedexpanthenolconcen

5、trationintheStandardPreparation.ModifiedPantothenateMedium—Acid-HydrolyzedCaseinSolution25mLCystine–TryptophaneSolution25mLPolysorbate80Solution0.25mLDextrose,Anhydrous10gSodiumAcetate,Anhydrous5gAdenine–Guanine–UracilSolution5mLRiboflavin–ThiamineHydrochloride–BiotinSol

6、ution5mLPara-aminobenzoicAcid–Niacin–PyridoxineHydrochlorideSolution5mLSaltSolutionA5mLSaltSolutionB5mLPyridoxal-CalciumPantothenateSolution5mLPolysorbate40–OleicAcidSolution5mLDissolvetheanhydrousdextroseandsodiumacetateinthesolutionspreviouslymixed,andadjustwith1Nsodiu

7、mhydroxidetoapHof6.8.Finally,dilutewithwaterto250mL,andmix.Double-StrengthModifiedPantothenateMedium—PrepareasdirectedunderModifiedPantothenateMedium,butmakethefinaldilutionto125mLinsteadof250mL.Preparefresh.Acid-HydrolyzedCaseinSolution—Mix100gofvitamin-freecaseinwith50

8、0mLof6Nhydrochloricacid,andrefluxthemixturefor8to12hours.Removethehydrochloricacidfromthemixturebydisti