新药杂质指导原则

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1、EuropeanMedicinesAgencyOctober2006CPMP/ICH/2737/99ICHTopicQ3A(R2)ImpuritiesinnewDrugSubstancesICHStep5NOTEFORGUIDANCEONIMPURITIESTESTING:IMPURITIESINNEWDRUGSUBSTANCESTRANSMISSIONTOCPMPNovember1999TRANSMISSIONTOINTERESTEDPARTIESNovember1999RELEASEFORCONSULTATIONNove

2、mber1999DEADLINEFORCOMMENTSMay2000APPROVALBYCPMPFebruary2002DATEFORCOMINGINTOOPERATIONAugust2002REVISEDATTACHMENT2October20067WestferryCircus,CanaryWharf,London,E144HB,UKTel.(44-20)74188575Fax(44-20)75237040E-mail:mail@emea.europa.euhttp://www.emea.europa.eu©EMEA20

3、06Reproductionand/ordistributionofthisdocumentisauthorisedfornoncommercialpurposesonlyprovidedtheEMEAisacknowledgedIMPURITIESTESTINGGUIDELINE:IMPURITIESINNEWDRUGSUBSTANCESTABLEOFCONTENTS1.PREAMBLE32.CLASSIFICATIONOFIMPURITIES33.RATIONALEFORTHEREPORTINGANDCONTROLOFI

4、MPURITIES43.1OrganicImpurities43.2InorganicImpurities43.3Solvents54.ANALYTICALPROCEDURES55.REPORTINGIMPURITYCONTENTOFBATCHES56.LISTINGOFIMPURITIESINSPECIFICATIONS67.QUALIFICATIONOFIMPURITIES78.GLOSSARY9Attachment1-Thresholds11Attachment2-IllustrationofReportingImpu

5、rityResultsforIdentificationandQualificationinanApplication12Attachment3-DecisionTreeforIdentificationandQualification14©EMEA20062ImpuritiesTestingGuideline:ImpuritiesinNewDrugSubstances1.PREAMBLEThisdocumentisintendedtoprovideguidanceforregistrationapplicationsont

6、hecontentandqualificationofimpuritiesinnewdrugsubstancesproducedbychemicalsynthesesandnotpreviouslyregisteredinaregionormemberstate.Itisnotintendedtoapplytonewdrugsubstancesusedduringtheclinicalresearchstageofdevelopment.Thefollowingtypesofdrugsubstancesarenotcover

7、edinthisguideline:biological/biotechnological,peptide,oligonucleotide,radiopharmaceutical,fermentationproductandsemi-syntheticproductsderivedtherefrom,herbalproducts,andcrudeproductsofanimalorplantorigin.Impuritiesinnewdrugsubstancesareaddressedfromtwoperspectives:

8、ChemistryAspectsincludeclassificationandidentificationofimpurities,reportgeneration,listingofimpuritiesinspecifications,andabriefdiscussionofanal