Q3A-新原料药中的杂质.doc

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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineImpuritiesInNewDrugSubstancesQ3A(R2)CurrentStep4versiondated25October2006ThisGuidelinehasbeendevelopedbytheappropriate

2、ICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.22/22Q3A(R2)DocumentHistoryFirstCodificat

3、ionHistoryDateNewCodificationNovember2005Q3ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.15March1994Q3AQ3AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q3wasrenamedQ3A.30March1

4、995Q3AQ3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep2andreleaseforpublicconsultation.7October1999Q3A(R1)Q3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.6February20

5、02Q3A(R1)CurrentStep4versionQ3A(R2)ApprovalbytheSteeringCommitteeoftherevisionoftheAttachment2directlyunderStep4withoutfurtherpublicconsultation.25October2006Q3A(R2)22/22ImpuritiesInNewDrugSubstancesICHHarmonisedTripartiteGuidelineHavingreachedStep4ofthe

6、ICHProcessattheICHSteeringCommitteemeetingon7February2002,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH.Attachment2hasbeenrevisedon25October2006.TABLEOFCONTENTS1.PREAMBLE12.CLASSIFICATIONOFIMPURITIES13.RATIONALEFORTHEREPORTINGANDC

7、ONTROLOFIMPURITIES23.1OrganicImpurities23.2InorganicImpurities43.3Solvents44.ANALYTICALPROCEDURES45.REPORTINGIMPURITYCONTENTOFBATCHES56.LISTINGOFIMPURITIESINSPECIFICATIONS67.QUALIFICATIONOFIMPURITIES88.GLOSSARY9ATTACHMENT113ATTACHMENT214ATTACHMENT31522/2

8、2ImpuritiesInNewDrugSubstances新原料药中的杂质1.PREAMBLE序言Thisdocumentisintendedtoprovideguidanceforregistrationapplicationsonthecontentandqualificationofimpuritiesinnewdrugsubstancesproducedbychemicalsynthesesandnotpreviouslyreg