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1、PropranololHydrochlorideandHydrochlorothiazideExtended-ReleaseCapsules»PropranololHydrochlorideandHydrochlorothiazideExtended-ReleaseCapsulescontainnotlessthan90.0percentandnotmorethan110.0percentofthelabeledamountsofpropranololhydrochloride(Ci6H2iNO2-HCI)andhydrochlorothiazide(C7H8CIN3O4S2
2、).Packagingandstorage—Preserveinwell-closedcontainers・USPReferencestandards〈11>—USPBenzothiadiazineRelatedCompound力RS回.USPHydrochlorothiazideRS.USPPropranololHydrochlorideRS.Identification—A:TransferthecontentsofanumberofCapsules,equivalenttoabout100mgofhydrochlorothiazide,toa20-meshsieve.B
3、reakupanylargelumpswiththeaidofaspatula,andcollectthepowderthatpassesthroughthesieve・[NOTE—RetainthematerialonthescreenforIdentificationtestB.]Transferthepowderthatpassedthroughthesievetoascrew-capped,35-mLcentrifugetube,add5mLofsolventhexane,andshakefor5minutes.Centrifuge,anddiscardthesolv
4、ent.Totheresidueinthecentrifugetubeadd10mLof1Nsodiumhydroxide,shake,andfilter,collectingthefiltrateinaseparator.Washthefilterwith5mLofwater,andcollectthewashingintheseparator.Add50mLofethertotheseparator,shakefor2minutes3andallowthephasestoseparate.Draintheaqueouslayerintoabeaker,adjustwith
5、6NhydrochloricacidtoapHofabout2,inducecrystallizationbyscratchingtheinnersurfaceofthebeakerwithaglassrod,andallowtostanduntilcrystallizationiscomplete.Collectthecrystalsonafilter,anddryat105°for30minutes.Grindthecrystalstoafinepowder:theIRabsorptionspectrumofamineraloildispersionofthepowder
6、soobtainedexhibitsmaximaonlyatthesamewavelengthsasthatofasimilarpreparationofUSPHydrochlorothiazideRS.B:WashthematerialretainedonthescreenfromIdentificationtestAwithasmallamountofwater,discardingthewashings・Transfertheparticlesremainingonthescreentoaglassmortar,addabout5mLofwater,andtritura
7、tethemixturewithaglasspestle・Transferthesuspension,withtheaidofabout10mLofwater,toa35-mLscrew-cappedcentrifugetube,addabout1mLof1Nsodiumhydroxide,andmix.Addabout15mLofether,andshakebymechanicalmeansfor5minutes・Centrifugethemixture,andtransferasmuchofthee
