如果您无法下载资料，请参考说明：
1、部分资料下载需要金币，请确保您的账户上有足够的金币
2、已购买过的文档，再次下载不重复扣费
3、资料包下载后请先用软件解压，在使用对应软件打开
Accessedfrom128.83.63.20bynEwp0rt1onWedNov2323:31:20EST20112980Doxepin/OfficialMonographsUSP35thatareidenticalwiththoseobtainedwiththeStandardPackagingandstorageÐPreserveintightcontainers,andsolution.storeatcontrolledroomtemperature,exceptwhereitislabeledUniformityofdosageunits〈905〉Ðasamorphous,inwhichcaseitshouldbestoredinthefreezer.FORORALSOLUTIONPACKAGEDINSINGLE-UNITCONTAINERS:LabelingÐTheamorphousformissolabeled.meetstherequirements.USPReferencestandards〈11〉ÐDeliverablevolume〈698〉ÐUSPDoxorubicinHydrochlorideRSFORORALSOLUTIONPACKAGEDINMULTIPLE-UNITCONTAINERS:meetsIdentificationÐTheretentiontimeofthedoxorubicinpeakintherequirements.thechromatogramoftheAssaypreparationcorrespondstothatpH〈791〉:between4.0and7.0,thetestspecimenbeingal-inthechromatogramoftheStandardpreparation,asobtainedlowedtoremainincontactwiththeelectrodesfor15minutesintheAssay.priortothemeasurement.Crystallinity〈695〉:meetstherequirements,exceptthatAssayÐTransferanaccuratelymeasuredvolumeofOralSolu-whereitislabeledasamorphous,mostoftheparticlesdonottion,equivalentto100mgofdoxepin,toa100-mLvolumetricexhibitbirefringenceandextinctionpositions.flask,dilutewithdilutehydrochloricacid(1in120)tovolume,pH〈791〉:between4.0and5.5,inasolutioncontaining5mgandmix.Dilute4.0mLofthissolutionwiththesamesolventtopermL.50.0mL.Transfer15.0mLoftheresultingsolutiontoa125-mLseparator,andextractwithtwo20-mLportionsofether.DiluteWater,MethodI〈921〉:notmorethan4.0%.10.0mLoftheextractedaqueousphasewithdilutehydrochlo-ChromatographicpurityÐProceedasdirectedintheAssay,ricacid(1in120)to25.0mL.PrepareaStandardsolutionexcepttouse,insteadoftheAssaypreparation,atestsolutionfromasuitablequantityofUSPDoxepinHydrochlorideRS,bypreparedbydissolvingDoxorubicinHydrochlorideinMobilequantitativeandstepwisedilutionwithdilutehydrochloricacidphasetoobtainasolutioncontainingabout0.5mgpermL.(1in120)toobtainasolutionhavingaknownconcentrationFromthechromatogramofthetestsolution,calculatetheper-ofabout1.1mgpermL.Takea4-mLa
立即下载
