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1、467RESIDUALSOLVENTSINTRODUCTIONThisgeneralchapterappliestoexistingdrugsubstances,excipients,andproducts.Allsubstancesandproductsaresubjecttorelevantcontrolofsolventslikelytobepresentinasubstanceorproduct.Wherethelimitstobeappliedcomplywiththosegivenbelow,testsforresidualsolventsarenotg
2、enerallymentionedinspecificmonographsbecausethesolventsemployedmayvaryfromonemanufacturertoanother.Theobjectiveofthisgeneralchapteristoprovideacceptableamountsofresidualsolventsinpharmaceuticalsforthesafetyofthepatient.Thegeneralchapterrecommendstheuseoflesstoxicsolventsanddescribeslev
3、elsconsideredtobetoxicologicallyacceptableforsomeresidualsolvents.Forpharmacopeialpurposes,residualsolventsinpharmaceuticalsaredefinedasorganicvolatilechemicalsthatareusedorproducedinthemanufactureofdrugsubstancesorexcipients,orinthepreparationofdrugproducts.Theresidualsolventsarenotco
4、mpletelyremovedbypracticalmanufacturingtechniques.Appropriateselectionofthesolventforthesynthesisofadrugsubstanceoranexcipientmayenhancetheyield,ordeterminecharacteristicssuchascrystalform,purity,andsolubility.Therefore,thesolventmaysometimesbeacriticalelementinthesyntheticprocess.This
5、generalchapterdoesnotaddresssolventsdeliberatelyusedasexcipientsnordoesitaddresssolvates.However,thecontentofsolventsinsuchproductsshouldbeevaluatedandjustified.Becauseresidualsolventsdonotprovidetherapeuticbenefit,theyshouldberemoved,totheextentpossible,tomeetingredientandproductspeci
6、fications,goodmanufacturingpractices,orotherquality-basedrequirements.Drugproductsshouldcontainnohigherlevelsofresidualsolventsthancanbesupportedbysafetydata.Solventsthatareknowntocauseunacceptabletoxicities(Class1,Table1)shouldbeavoidedintheproductionofdrugsubstances,excipients,ordrug
7、productsunlesstheirusecanbestronglyjustifiedinarisk-benefitassessment.Solventsassociatedwithlessseveretoxicity(Class2,Table2)shouldbelimitedinordertoprotectpatientsfrompotentialadverseeffects.Ideally,lesstoxicsolvents(Class3,Table3)shouldbeusedwherepractical.Thecompletelistofsolvents
