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1、NifedipineExtended-ReleaseTablets»NifedipineExtended-ReleaseTabletscontainnotlessthan90.0percentandnotmorethan110.0percentofthelabeledamountofnifedipine(C17H18N2O6).Packagingandstorage—Preserveintight,light-resistantcontainers,andstoreatcontrolledroomtemperature.Labeling—Thelabe
2、lingindicatestheDrugReleaseTestwithwhichtheproductcomplies.Labeling—ThelabelingindicatestheDissolutionTestwithwhichtheproductcomplies.(OfficialApril1,2006)USPReferencestandards11—USPNifedipineRS.USPNifedipineNitrophenylpyridineAnalogRS.USPNifedipineNitrosophenylpyridineAnalogRS.
3、NOTE—Nifedipine,whenexposedtodaylightandcertainwavelengthsofartificiallight,readilyconvertstoanitrosophenylpyridinederivative.ExposuretoUVlightleadstotheformationofanitrophenylpyridinederivative.Performassaysandtestsinthedarkorundergoldenfluorescentorotherlow-actiniclight.Uselow
4、-actinicglassware.Identification—A:TheretentiontimeofthemajorpeakinthechromatogramoftheAssaypreparationcorrespondstothatinthechromatogramoftheStandardpreparation,asobtainedintheAssay.B:UltravioletAbsorption197U—Solutions—PrepareatestsolutionasdirectedfortheAssaypreparationintheA
5、ssay,excepttodilutefurtherwithMobilephasetoobtainasolutionhavingaconcentrationofabout0.02mgpermL.PreparetheStandardsolutionasdirectedfortheStandardpreparationintheAssayunderNifedipine,excepttodilutefurtherwithMobilephasetoobtainasolutionhavingaknownconcentrationofabout0.02mgperm
6、L.Drugrelease724—TEST1—Iftheproductcomplieswiththistest,thelabelingindicatesthatitmeetsUSPDrugReleaseTest1.Medium:water;50mL.Apparatus7:15to30cyclesperminute.Donotusethereciprocatingdisk,butusea25-cmplexiglasrod,theperimeteroftheTabletsbeingaffixedtotherodwithawater-insolubleglu
7、e.Thesolutioncontainersare25-mmtesttubes,150to200mminlength,andthewaterbathismaintainedat37±0.5.Attheendofeachspecifiedtestinterval,thesystemsaretransferredtothenextrowofnewtesttubescontaining50mLoffreshMedium.Times:4,8,12,16,20,and24hours.Dilutingsolution:amixtureofmethanolandw
8、ater(1:1).Standardsolutions—Transferabout50mgof
