ICH Q3C R5 残留溶剂指导原则

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEIMPURITIES:GUIDELINEFORRESIDUALSOLVENTSQ3C(R5)CurrentStep4versiondated4February2011ParentGuidelinedated17July1997(RevisedPDEforTHFandNMPdatedSeptemb

2、er2002andOctober2002incorporatedincoreGuidelineinNovember2005andrevisedPDEforCumeneincorporatedincoreGuidelineinFebruary2011)ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4of

3、theProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Q3C(R5)DocumentHistoryFirstHistoryDateNewCodificationCodificationParentGuideline:Impurities:GuidelineforResidualSolventsQ3CApprovalbytheSteeringCommitteeunderStep2andrelease6Q3Cforpubli

4、cconsultation.November1996Q3CApprovalbytheSteeringCommitteeunderStep4and17JulyQ3CrecommendationforadoptiontothethreeICHregulatory1997bodies.RevisionofthePDEinformationforTHFcontainedintheParentGuidelineQ3C(M)PermissibleDailyExposure(PDE)forTetrahydrofuran(THF):20JulyinQ3C(R1)forTHFre

5、visionofPDEbasedonnewtoxicologicaldata.2000ApprovalbytheSteeringCommitteeofthenewPDEforTHFunderStep2andreleaseforpublicconsultation.Q3C(M)ApprovalbytheSteeringCommitteeunderStep4and12inQ3C(R1)forTHFrecommendationforadoptiontothethreeICHregulatorySeptemberbodies.2002RevisionofPDEinfor

6、mationforNMPcontainedintheParentGuidelineQ3C(M)forPermissibleDailyExposure(PDE)forN-Methylpyrrolidone20JulyinQ3C(R2)NMP(NMP):revisionofPDEbasedonnewtoxicologicaldata.2000ApprovalbytheSteeringCommitteeoftheRevisionunderStep2andreleaseforpublicconsultation.Q3C(M)forApprovalbytheSteerin

7、gCommitteeunderStep4and12inQ3C(R2)NMPrecommendationforadoptiontothethreeICHregulatorySeptemberbodies.2002Q3C(M)forCorrigendumtocalculationformulaapprovedbytheSteering28OctoberinQ3C(R3)NMPCommittee.2002Q3C,Q3C(M)TheparentGuidelineisnowrenamedQ3C(R3)asthetwoNovemberQ3C(R3)forTHFandupda

8、tes(PDEforN-