q3a(r2)-新原料药中的杂质(中英文)

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1、ImpuritiesInNewDrugSubstances新原料药中的杂质INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineImpuritiesInNewDrugSubstancesQ3A(R2)CurrentStep4versiondated25October2006ThisGuidelineha

2、sbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Page22of22Impuriti

3、esInNewDrugSubstances新原料药中的杂质Q3A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q3ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.15March1994Q3AQ3AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadop

4、tiontothethreeICHregulatorybodies.Q3wasrenamedQ3A.30March1995Q3AQ3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep2andreleaseforpublicconsultation.7October1999Q3A(R1)Q3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep4andrecommendationf

5、oradoptiontothethreeICHregulatorybodies.6February2002Q3A(R1)CurrentStep4versionQ3A(R2)ApprovalbytheSteeringCommitteeoftherevisionoftheAttachment2directlyunderStep4withoutfurtherpublicconsultation.25October2006Q3A(R2)Page22of22ImpuritiesInNewDrugSubstances新原料药中的

6、杂质ImpuritiesInNewDrugSubstancesICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon7February2002,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH.Attachment2hasbeenrevisedon25October2006.TABLEO

7、FCONTENTS1.PREAMBLE12.CLASSIFICATIONOFIMPURITIES13.RATIONALEFORTHEREPORTINGANDCONTROLOFIMPURITIES23.1OrganicImpurities23.2InorganicImpurities43.3Solvents44.ANALYTICALPROCEDURES45.REPORTINGIMPURITYCONTENTOFBATCHES56.LISTINGOFIMPURITIESINSPECIFICATIONS67.QUALIFIC

8、ATIONOFIMPURITIES88.GLOSSARY9ATTACHMENT113ATTACHMENT214ATTACHMENT315Page22of22ImpuritiesInNewDrugSubstances新原料药中的杂质ImpuritiesInNewDrugSubstances新原料药中的杂质1.PREAMBLE序言Thisdocum