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Impurities:GuidelineforResidualSolventsPAGEiiiINTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineImpurities:GuidelineforResidualSolventsQ3C(R4)CurrentStep4versiondatedFebruary2009ParentGuidelinedated17July1997(RevisedPDEforTHFandNMPdated12September2002and28October2002incorporatedinNovember2005)ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.PROPOSAL:Q3C(R4)DocumentHistoryFirstCodificationHistoryDateNewCodificationNov.2005ParentGuideline:Impurities:GuidelineforResidualSolventsQ3CApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.6November1996Q3CQ3CApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.17July1997Q3CRevisionofthePDEinformationforTHFcontainedintheParentGuidelineQ3C(M)forTHFPermissibleDailyExposure(PDE)forTetrahydrofuran(THF):revisionofPDEbasedonnewtoxicologicaldata.ApprovalbytheSteeringCommitteeofthenewPDEforTHFunderStep2andreleaseforpublicconsultation.20July2000inQ3C(R1)Q3C(M)forTHFApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.12September2002inQ3C(R1)RevisionofPDEinformationforNMPcontainedintheParentGuidelineQ3C(M)forNMPPermissibleDailyExposure(PDE)forN-Methylpyrrolidone(NMP):revisionofPDEbasedonnewtoxicologicaldata.ApprovalbytheSteeringCommitteeoftheRevisionunderStep2andreleaseforpublicconsultation.20July2000inQ3C(R2)Q3C(M)forNMPApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.12September2002inQ3C(R2)Q3C(M)forNMPCorrigendumtocalculationformulaapprovedbytheSteeringCommittee.28October2002inQ3C(R3)Q3C,Q3C(M)forTHFandQ3C(M)forNMPTheparentguidelineisnowrenamedQ3C(R3)asthetwou
