USP711

Medium,Apparatus,Times,andAnalysis:Asgiveninthemonographfollowingtheappropriatetestnumberfoundonthelabeling.Acceptancecriteria:ThepercentagesofthelabeledamountreleasedatthetimesspecifiedconformtotheL2levelcriteriaofAcceptanceTable2iná711ñ.DISINTEGRATIONDisintegrationtestingisnecessaryonlywhenusedasasurrogatefordissolutiontestingasspecifiedinthemonograph.Fol-lowtheprocedureusingsplitportionsfromtabletsthatareacceptableaccordingtotheSplittingTabletswithFunctionalScoringtestasthedosageunit(seeDisintegrationá701ñ).á711ñDISSOLUTIONGeneralchapterDissolutioná711ñisbeingharmonizedwiththecorrespondingtextsoftheEuropeanPharmacopoeiaand/ortheJapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.PortionsofthepresentgeneralchaptertextthatarenationalUSPtext,andthereforenotpartoftheharmonizedtext,aremarkedwithsymbols(♦♦)tospecifythisfact.Thistestisprovidedtodeterminecompliancewiththedissolutionrequirements♦wherestatedintheindividualmonograph♦fordosageformsadministeredorally.Inthisgeneralchapter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.♦Ofthetypesofapparatusdesignsdescribedherein,usetheonespecifiedintheindividualmonograph.Wherethelabelstatesthatanarticleisentericcoatedandadissolutionordisintegrationtestdoesnotspecificallystatethatitistobeappliedtodelayed-releasearticlesandisincludedintheindividualmonograph,theprocedureandinterpretationgivenforDelayed-ReleaseDosageFormsareapplied,unlessotherwisespecifiedintheindividualmonograph.FORDOSAGEFORMSCONTAININGORCOATEDWITHGELATINIfthedosageformcontaininggelatindoesnotmeetthecriteriaintheappropriateAcceptanceTable(seeInterpretation,Im-mediate-ReleaseDosageForms,Extended-ReleaseDosageForms,orDelayed-ReleaseDosageForms)becauseofevidenceofthepresenceofcross-linking,thedissolutionprocedureshouldberepeatedwiththeadditionofenzymestothemedium,asde-scribedbelow,andthedissolutionresultsshouldbeevaluatedstartingatthefirststageoftheappropriateAcceptanceTable.Itisnotnecessarytocontinuetestingthroughthelaststage(upto24units)whencriteriaarenotmetduringthefirststagetesting,andevidenceofcross-linkingisobserved.Gelatin,inthepresenceofcertaincompoundsand/orincertainstorageconditions,includingbutnotrestrictedtohighhu-midityandtemperature,maypresentcross-linking.Apelliclemayformontheexternaland/orinternalsurfaceofthegelatincapsuleshelloronthedosageformthatpreventsthedrugfrombeingreleasedduringdissolutiontesting(seemoreinforma-tioninCapsules—DissolutionTestingandRelatedQualityAttributesá1094ñ).NOTE—Allreferencestoachapteraboveá1000ñareforinformationpurposesonly,foruseasahelpfulresource.Thesechap-tersarenotmandatoryunlessexplicitlycalledoutforthisapplication.DissolutionMediumwithpH£4.0Enzyme:Pepsin,activitydeterminedbytheprocedureinpurifiedpepsin,intheReagentSpecificationssectionAmount:AquantityofpepsinthatresultsinanactivityofNMT750,000Units/LofdissolutionmediumDissolutionMediumwithpH4.0and6.8Enzyme:Papain,activitydeterminedbytheAssaytestinthemonographforPapain;orbromelain,activitydeterminedbytheprocedureinbromelain,intheReagentSpecificationssectionAmount:AquantityofpapainthatresultsinanactivityofNMT550,000Units/Lofdissolutionmedium,oraquantityofbromelainthatresultsinanactivityofNMT30gelatin-digestingunits(GDU)/LofdissolutionmediumDissolutionMediumwithpH³6.8Enzyme:Pancreatin,proteaseactivitydeterminedbytheprocedureinAssayforproteaseactivity(Caseindigestivepower)inthemonographforPancreatinAmount:AquantityofpancreatinthatresultsinaproteaseactivityofNMT2000Units/LofdissolutionmediumGeneralChapters588á705ñFunctionallyScoredTablets/PhysicalTestsUSP40OfficialfromDecember1,2017Copyright(c)2018TheUnitedStatesPharmacopeialConvention.Allrightsreserved.Accessedfrom60.191.164.106byhuahainfonSunJan2121:14:50EST2018DissolutionMediumContainingSurfactantorOtherIngredientsKnowntoDenaturetheEnzymeIfthedissolutionmediumcontainssurfactantorotheringredientsthatareknowntodenaturetheenzymeused,apretreat-mentstepinthedissolutiontestingofthedosageformmaybeapplied.Thispretreatmentstepisdoneusingthespecifieddissolutionmediumwithoutthesurfactantortheingredientandwiththeadditionoftheappropriateamountofenzymeac-cordingtothemediumpH.Theamountofenzymeaddedisappropriatetothevolumeofdissolutionmediumusedinthepretreatment.Toachievethespecifiedmediumvolumeforthefinaldissolutiontesting,thepretreatmentstepmaybeconduc-tedwithasmallervolumeofmediumwithouttheingredientsuchthatthefinalvolumeisobtainedwhentheingredientisaddedattheendofthepretreatmentstep.Alloftheotherconditionsofthetest(apparatus,rotation,orflowrate)shouldremainasdescribedinthemethodormonograph.Typically,thedurationofthepretreatmentstepisNMT15min.There-quiredpretreatmenttimeshouldbeevaluatedonacase-by-casebasisandshouldbescientificallyjustified.Thistimeshouldbeincludedinthetotaltimeofthetest.Asanexample,ifthetotaltimeofthetestis45minand15minareusedinthepretreat-mentstep,thetestwillcontinuefor30minaftertheadditionoftheingredient.♦APPARATUSApparatus1(BasketApparatus)Theassemblyconsistsofthefollowing:avessel,wh