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Maltodextrin

Maltodextrinisanonsweet,nutritivesaccharidemixtureofpolymersthatconsistsofDglucoseunits,
withaDextroseEquivalentlessthan20.Itispreparedbythepartialhydrolysisofafoodgradestarch
withsuitableacidsand/orenzymes.Itmaybephysicallymodifiedtoimproveitsphysicalandfunctional
characteristics.
PackagingandstoragePreserveintightcontainers,orinwellclosedcontainersatatemperaturenotexceeding30 and
arelativehumiditynotexceeding50%.
USPReferencestandards 11 USPDextroseRS.
Microbiallimits 61 ItmeetstherequirementsofthetestsforabsenceofSalmonellaspeciesandEscherichiacoli.
pH 791 :between4.0and7.0,ina1in5solutionincarbondioxidefreewater.
Lossondrying 731 Dryitat105 for2hoursinaforcedairoven:itlosesnotmorethan6.0%ofitsweight.
Residueonignition 281 :notmorethan0.5%.
Heavymetals,MethodII 231 :5ppm.
ProteinTransferabout10gofMaltodextrin,accuratelyweighed,toan800mLKjeldahlflask,andadd10gofanhydrous
potassiumsulfateorsodiumsulfate,300mgofcopperseleniteormercuricoxide,and60mLofsulfuricacid.Gentlyheat
themixture,keepingtheflaskinclinedatabouta45 angle,andafterfrothinghasceased,boilbrisklyuntilthesolutionhas
remainedclearforabout1hour.Cool,verycautiouslyaddabout50mLofwaterwhileswirlingtodissipatetheresulting
heat.Addanadditional150to250mLofwater,mix,andcoolagain.Cautiouslypourabout75mL(orenoughtomakethe
mixturestronglyalkaline)ofsodiumhydroxidesolution(2in5)downtheinsideoftheflasksothatitformsalayerunderthe
acidsolution,andthenaddafewpiecesofgranularzinc.Immediatelyconnecttheflasktoadistillationapparatus
consistingofaKjeldahlconnectingbulbandacondenser,thedeliverytubeofwhichextendswellbeneaththesurfaceofan
accuratelymeasuredexcessof0.1Nsulfuricacidcontainedina500mLflask.GentlyrotatethecontentsoftheKjeldahl
flasktomix,anddistilluntilallammoniahaspassedintotheabsorbingacidsolution(about250mLofdistillate).Tothe
receivingflaskadd0.25mLofmethylredmethyleneblueTS,andtitratetheexcessacidwith0.1Nsodiumhydroxide.
Performablankdetermination,substitutingpuresucroseordextroseforthetestspecimen,andmakeanynecessary
correction.EachmLof0.1Nsulfuricacidconsumedisequivalentto1.401mgofnitrogen(N).Calculatethepercentageof
Ninthespecimentaken,andthencalculatethepercentageofproteinbymultiplyingthepercentageofNby6.25.Thelimit
is0.1%.
Sulfurdioxide
HydrogenperoxidesolutionDilute30percenthydrogenperoxidewithwatertoobtaina3%solution.Justbeforeuse,add
3dropsofmethylredTS,andneutralizetoayellowendpointwith0.01Nsodiumhydroxide.Donotexceedtheendpoint.
NitrogenUsehighpuritynitrogen,withaflowregulatorthatwillmaintainaflowof20010mLperminute.Guardagainst

thepresenceofoxygenbypassingthenitrogenthroughascrubber,suchasalkalinepyrogallol,preparedasfollows.Add
4.5gofpyrogalloltoagaswashingbottle,purgethebottlewithnitrogenfor3minutes,andaddasolutioncontaining85mL
ofwaterand65gofpotassiumhydroxide,whilemaintaininganatmosphereofnitrogeninthebottle.
ApparatusTheapparatus(seeFig.1)isdesignedtoeffecttheselectivetransferofsulfurdioxidefromthespecimenin
boilingaqueoushydrochloricacidtotheHydrogenperoxidesolution.Thebackpressureislimitedtotheunavoidable
pressureduetotheheightoftheHydrogenperoxidesolutionabovethetipofthebubbler,F.Keepingthebackpressureas
lowaspossiblereducesthelikelihoodthatsulfurdioxidewillbelostthroughleaks.Preboilvinylandsiliconetubing.Applya
thinfilmofstopcockgreasetothesealingsurfacesofallofthejointsexceptthejointbetweentheseparatoryfunneland
theflask,andclampthejointstoensuretightness.Theseparatoryfunnel,B,hasacapacityof100mLorgreater.Theinlet
adapter,A,withahoseconnectorprovidesameansofapplyingheadpressureoverthesolution.[NOTEApressure
equalizingdroppingfunnelisnotrecommendedbecausecondensate,whichmaycontainsulfurdioxide,isdepositedinthe
funnelandthesidearm.]

Fig.1.ApparatusforSulfurdioxidetest.
Theroundbottomflask,C,isa1000mLflaskwiththree24/40taperedjoints.Thegasinlettube,D,islongenoughto
permitintroductionofthenitrogenwithin2.5cmofthebottomoftheflask.TheAllihncondenser,E,hasajacketlengthof
300mm.Thebubbler,F,(seeFig.2)isfabricatedfromglassaccordingtothedimensionsgiveninFigure2.TheHydrogen
peroxidesolutioniscontainedinavessel,G,havinganinsidediameterofabout2.5cmandadepthofabout18cm.
Circulatecoolant,suchasamixtureofwaterandmethanol(4:1)maintainedat5 ,tochillthecondenser.

Fig.2.Bubbler(F)forSulfurDioxideApparatus.
ProcedurePositiontheApparatusinaheatingmantlecontrolledbyapowerregulatingdevice.Add400mLofwatertothe
flask.Closethestopcockoftheseparatoryfunnel,andadd90mLof4Nhydrochloricacidtotheseparatoryfunnel.Begin
theflowofnitrogenatarateof20010mLperminute.Startthecondensercoolantflow.Add30mLofHydrogenperoxide
solutiontovesselG.After15minutes,removetheseparatoryfunnel,andtransferamixtureof50.0gofMaltodextrin,
accuratelyweighed,and100mLofalcoholsolution(5in100).Applystopcockgreasetotheouterjointoftheseparatory
funnel,returntheseparatoryfunneltothetaperedjointflask,andconcomitantlyresumethenitrogenflow.Apply
headpressureabovethehydrochloricacidsolutionintheseparatoryfunnelwitharubberbulbequippedwithavalve.Open
thestopcockoftheseparatoryfunneltopermitthehydrochloricacidsolutiontoflowintotheflask.Continuetomaintain
sufficientpressureabovethehydrochloricacidsolutiontoforceitintotheflask.[NOTEThestopcockmaybetemporarily
closed,ifnecessary,topumpupthepressure.]Toguardagainstescapeofsulfurdioxideintotheseparatoryfunnel,close
thestopcockbeforethelastfewmLofhydrochloricaciddrainout.Applypowertotheheatingmantlesufficienttocause
about85dropsofrefluxperminute.Afterrefluxingfor1.75hours,removevesselG,add3dropsofmethylredTS,and
titratethecontentswith0.01NsodiumhydroxideVS,usinga10mLburetwithanoverflowtubeandahoseconnectiontoa
carbondioxideabsorbingtube,toayellowendpointthatpersistsforatleast20seconds.Performablankdetermination,
andmakeanynecessarycorrection(seeTitrimetry 541 ).Calculatethequantity,ing,ofSO2ineachgofthe
Maltodextrintakenbytheformula:
1000(32.03)VN/W,
inwhich32.03isthemilliequivalentweightofsulfurdioxideVisthevolume,inmL,oftitrantconsumedNisthenormality
ofthetitrantandWistheweight,ing,ofMaltodextrintaken.Notmorethan40gofsulfurdioxidepergofMaltodextrin
arefound(.004%).
Dextroseequivalent
StandardsolutionDissolveanaccuratelyweighedquantityofUSPDextroseRSinwater,anddilutequantitativelywith
watertoobtainasolutionhavingaknownconcentrationofabout10mgpermL.
TestsolutionTransferabout5gofMaltodextrin,accuratelyweighed,withtheaidofhotwatertoa100mLvolumetric
flask,cool,addwatertovolume,andmix.
ProcedureTransfer25.0mLportionsofalkalinecuprictartrateTStoeachoftwoboilingflasks.Bringthecontentsofone
flasktoboilingwithinabout2minuteswhiletitratingwithStandardsolutiontowithin0.5mLoftheanticipatedendpoint.Boil
gentlyfor2minutes.Continuetoboilgently,add2dropsofmethylenebluesolution(1in100),andcompletethetitration
within1minutebyaddingtheStandardsolutiondropwiseorinsmallincrementsuntilthebluecolordisappears,determined
byviewingagainstawhitebackgroundindaylightorunderequivalentillumination.Ifmorethan0.5mLofthetitrantwas
requiredaftertheadditionoftheindicator,repeatthetitration,addingthenecessaryvolumeoftitrantbeforeaddingthe
indicator.Bringthecontentsofthesecondflasktoboiling,andsimilarlytitratewithTestsolution.CalculatetheDextrose
equivalent,onthedriedbasis,takenbytheformula:
[100/(1 0.01A)](CS/CU)(VS/VU),
inwhichAisthepercentageLossondryingoftheMaltodextrintakenCUistheconcentration,inmgpermL,of

MaltodextrinintheTestsolutionCSistheconcentration,inmgpermL,ofUSPDextroseRSintheStandardsolutionand
VUandVSarethetitratedvolumes,inmL,oftheTestsolutionandtheStandardsolution,respectively.TheDextrose
equivalentislessthan20.[NOTEThisisalimittest.ForMaltodextrinswithlowerreducingvalues,otherproceduresmay
giveotherresults.]
Residualsolvents 467 :meetstherequirements.
(OfficialJanuary1,2007)
AuxiliaryInformationStaffLiaison:HongWang,Ph.D.,SeniorScientificAssociate
ExpertCommittee:(EM205)ExcipientMonographs2
USP29NF24Page3368
PhoneNumber:13018168351