第1页共23页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共23页INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEIMPURITIESINNEWDRUGSUBSTANCESQ3A(R2)CurrentStep4versiondated25October2006ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.第2页共23页第1页共23页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共23页Q3A(R2)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q3ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.15March1994Q3AQ3AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.Q3wasrenamedQ3A.30March1995Q3AQ3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep2andreleaseforpublicconsultation.7October1999Q3A(R1)Q3A(R)ApprovalbytheSteeringCommitteeofthefirstRevisionunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.6February2002Q3A(R1)CurrentStep4versionQ3A(R2)ApprovalbytheSteeringCommitteeoftherevisionoftheAttachment2directlyunderStep4withoutfurtherpublicconsultation.25October2006Q3A(R2)第3页共23页第2页共23页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共23页IMPURITIESINNEWDRUGSUBSTANCESICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon7February2002,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH.Attachment2hasbeenrevisedon25October2006.TABLEOFCONTENTS1.PREAMBLE...............................................................................................................12.CLASSIFICATIONOFIMPURITIES.....................................................................13.RATIONALEFORTHEREPORTINGANDCONTROLOFIMPURITIES.......................................................................................................23.1OrganicImpurities.............................................................................................23.2InorganicImpurities..........................................................................................43.3Solvents...............................................................................................................44.ANALYTICALPROCEDURES................................................................................45.REPORTINGIMPURITYCONTENTOFBATCHES............................................56.LISTINGOFIMPURITIESINSPECIFICATIONS...............................................67.QUALIFICATIONOFIMPURITIES.......................................................................88.GLOSSARY................................................................................................................9ATTACHMENT1...........................................................................................................13ATTACHMENT2...........................................................................................................14ATTACHMENT3...........................................................................................................15第4页共23页第3页共23页编号：时间：2021年x月x日...
