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1、á467ñORGANICVOLATILEIMPURITIESRESIDUALSOLVENTSLIMITSForpharmacopeialpurposes,residualsolventsinpharmaceuticalsaredefinedasorganicvolatilechemicalsthatareusedorproducedinthemanufactureofdrugsubstancesorexcipients,orinthepreparationofdrugproducts.Theresidualsolventsarenotcompletelyremov
2、edbypracticalmanufacturingtechniques.Appropriateselectionofthesolventforthesynthesisofadrugsubstanceoranexcipientmayenhancetheyield,ordeterminecharacteristicssuchascrystalform,purity,andsolubility.Therefore,thesolventmaysometimesbeacriticalelementinthesyntheticprocess.ThisGeneralChapt
3、erdoesnotaddresssolventsdeliberatelyusedasexcipientsnordoesitaddresssolvates.However,thecontentofsolventsinsuchproductsshouldbeevaluatedandjustified.Becauseresidualsolventsdonotprovidetherapeuticbenefit,theyshouldberemoved,totheextentpossible,tomeetingredientandproductspecifications,g
4、oodmanufacturingpractices,orotherquality-basedrequirements.Drugproductsshouldcontainnohigherlevelsofresidualsolventsthancanbesupportedbysafetydata.Solventsthatareknowntocauseunacceptabletoxicities(Class1,Table1)shouldbeavoidedintheproductionofdrugsubstances,excipients,ordrugproductsun
5、lesstheirusecanbestronglyjustifiedinarisk-benefitassessment.Solventsassociatedwithlessseveretoxicity(Class2,Table2)shouldbelimitedinordertoprotectpatientsfrompotentialadverseeffects.Ideally,lesstoxicsolvents(Class3,Table3)shouldbeusedwherepractical.Thecompletelistofsolventsincludedint
6、hisGeneralChapterisgiveninAppendix1.Thesetablesandthelistarenotexhaustive.Whereothersolventshavebeenused,basedonapprovalbythecompetentregulatoryauthority,suchsolventsmaybeaddedtothetablesandlist.Testingofdrugsubstances,excipients,anddrugproductsforresidualsolventsshouldbeperformedwhen
7、productionorpurificationprocessesareknowntoresultinthepresenceofsuchresidualsolvents.Itisonlynecessarytotestforresidualsolventsthatareusedorproducedinthemanufactureorpurificationprocesses.Althoughmanufacturersmaychoosetotestthedrugproduct,acumulativeproceduremaybeusedtocalculatetheres
8、idual
