ICH Q3C 杂质：残留溶剂指导原则（英文版）.pdf

EuropeanMedicinesAgency

March1998

CPMP/ICH/283/95

ICHTopicQ3C(R3)

Impurities:ResidualSolvents

Step5

NOTEFORGUIDANCEON

IMPURITIES:RESIDUALSOLVENTS

(CPMP/ICH/283/95)

TRANSMISSIONTOCPMPNovember1996

TRANSMISSIONTOINTERESTEDPARTIESNovember1996

COMMENTSREQUESTEDBEFOREMay1997

FINALAPPROVALBYCPMPSeptember1997

DATEFORCOMINGINTOOPERATIONMarch1998

7WestferryCircus,CanaryWharf,London,E144HB,UK

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EMEA2006Reproductionand/ordistributionofthisdocumentisauthorisedfornoncommercialpurposesonlyprovidedtheEMEAisacknowledged

ICHHarmonisedTripartiteGuideline

TableofContents

1.INTRODUCTION3

2.SCOPEOFTHEGUIDELINE3

3.GENERALPRINCIPLES4

3.1ClassificationofResidualSolventsbyRiskAssessment4

3.2MethodsforEstablishingExposureLimits4

3.3OptionsforDescribingLimitsofClass2Solvents4

3.4AnalyticalProcedures6

3.5Reportinglevelsofresidualsolvents6

4.LIMITSOFRESIDUALSOLVENTS7

4.1SolventstoBe