q3a(r2)-新原料药中的杂质(中英文)

《q3a(r2)-新原料药中的杂质(中英文)》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、ImpuritiesInNewDrugSubstances新原料药中的杂质INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHarmonisedTripartiteGuidelineImpuritiesInNewDrugSubstancesQ3A(R2)CurrentStep4versiondated25October2006ThisGuidelinehasbeendevelopedbytheappropriateICHExper

2、tWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.Page22of22ImpuritiesInNewDrugSubstances新原料药中的杂质Q3A(R2)DocumentHistoryFirstCodificationHistoryD

3、ateNewCodificationNovember2005Q3ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.15March1994Q3AQ3AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q3wasrenamedQ3A.30March1995Q3AQ3A(R)ApprovalbytheSteeringCommitteeofthefirstRevi

4、sionunderStep2andreleaseforpublicconsultation.7October1999Q3A(R1)Q3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.6February2002Q3A(R1)CurrentStep4versionQ3A(R2)ApprovalbytheSteeringCommitteeoftherevisionoftheAttachment2directl

5、yunderStep4withoutfurtherpublicconsultation.25October2006Q3A(R2)Page22of22ImpuritiesInNewDrugSubstances新原料药中的杂质ImpuritiesInNewDrugSubstancesICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon7February2002,thisguidelineisrecommendedforadoptiontothethre

6、eregulatorypartiestoICH.Attachment2hasbeenrevisedon25October2006.TABLEOFCONTENTS1.PREAMBLE12.CLASSIFICATIONOFIMPURITIES13.RATIONALEFORTHEREPORTINGANDCONTROLOFIMPURITIES23.1OrganicImpurities23.2InorganicImpurities43.3Solvents44.ANALYTICALPROCEDURES45.REPORTINGIMPURITYCONTENTOFBATCHES56.LISTINGOFIMPU

7、RITIESINSPECIFICATIONS67.QUALIFICATIONOFIMPURITIES88.GLOSSARY9ATTACHMENT113ATTACHMENT214ATTACHMENT315Page22of22ImpuritiesInNewDrugSubstances新原料药中的杂质ImpuritiesInNewDrugSubstances新原料药中的杂质1.PREAMBLE序言Thisdocum