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CholestyramineforOralSuspension

CholestyramineforOralSuspensionisamixtureofCholestyramineResinwith
suitableexcipientsandcoloringandflavoringagents.Itcontainsnotlessthan85.0
percentandnotmorethan115.0percentofthelabeledamountofdried
cholestyramineresin.
PackagingandstoragePreserveintightcontainers.

USPReferencestandards 11
USPCholestyramineResinRS.

IdentificationTransferaquantityofCholestyramineforOralSuspension,equivalenttoabout500mgof
driedcholestyramineresin,toasuitableflask,add100mLof0.1Nhydrochloricacid,stirtosuspendthe
solid,andheatonasteambathfor10minutes.Filter,washtheresiduewiththree50mLportionsofwater,
anddryat70 andatapressurenotexceeding50mmofmercuryfor16hours:theIRabsorption
spectrumofapotassiumbromidedispersionoftheresiduesoobtainedexhibitsmaximaonlyatthesame
wavelengthsasthatofasimilarpreparationofUSPCholestyramineResinRS.

Uniformityofdosageunits 905 :meetstherequirementsforWeightVariation.

Assay

Mobilephase,Potassiumphosphatebuffer,Sodiumglycocholatesolution,Referencesolution,Standard
solution,Systemsuitabilitysolution,andChromatographicsystemProceedasdirectedinthetestfor
ExchangecapacityunderCholestyramineResin.

TestsolutionTransferanaccuratelyweighedportionofCholestyramineforOralSuspension,equivalent
toabout100mgofcholestyramineresin,toa25mLconicalflask.Pipet15.0mLofSodiumglycocholate
solutionintotheflask,andstirbymechanicalmeansfor2hours.Transferthecontentstoacentrifugetube,
andcentrifugefor15minutes.Transfer5.0mLofthesupernatanttoa50mLvolumetricflask,anddilute
withwatertovolume.

ProcedureSeparatelyinjectequalvolumes(about50L)oftheReferencesolution,theStandard
solution,andtheTestsolutionintothechromatograph,recordthechromatograms,andmeasurethe
responsesforthemajorpeaks.Calculatethequantity,inmg,ofcholestyramineresinpermgof
CholestyramineforOralSuspensiontakenbytheformula:
[M(2.5rRrU)WS]/[(2.5rRrS)WUQ]

inwhichMisthestatedvalue,inmg,ofsodiumglycocholateabsorbedpergofUSPCholestyramine
ResinRSrR,rU,andrSarethepeakresponsesobtainedfromtheReferencesolution,theTestsolution,
andtheStandardsolution,respectivelyWSistheweight,inmg,ofUSPCholestyramineResinRStakento
preparetheStandardsolutionWUistheweight,inmg,ofCholestyramineforOralSuspensiontakento
preparetheTestsolutionandQisthequantityofsodiumglycocholateabsorbedpergofdried
cholestyramineresin,asobtainedinthetestforExchangecapacityunderCholestyramineResin.

AuxiliaryInformationPleasecheckforyourquestionintheFAQsbeforecontactingUSP.
Topic/Question Contact ExpertCommittee
Monograph ElenaGonikberg,Ph.D. (MDGRE05)MonographDevelopment
SeniorScientist GastrointestinalRenalandEndocrine
13018168251
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Topic/Question Contact ExpertCommittee

Reference LiliWang,Technical
Standards ServicesScientist
13018168129
RSTech@usp.org
USP32NF27Page1925
PharmacopeialForum:VolumeNo.28(1)Page51
ChromatographicColumn

CHOLESTYRAMINEFORORALSUSPENSION

Chromatographiccolumnstextisnotderivedfrom,andnotpartof,USP32orNF27.

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