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时间:2019-08-20
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1、ChemistrySpecificationsforChemistryServicesContractorsNationalToxicologyProgramAppendix3.1VehicleAnalysisofEthanolSeptember20,2013DoseVehicleAnalysisofEthanolNIEHSContractNo.N01-ES-55385ETPTaskNo.CHEM02363MRIProjectNo.4300MRITaskNo.792MidwestResearchInstitute425VolkerBoulevardKansasCity,Missouri64
2、110January29,1997EthanolCASNo.:64-17-15LotNo.:96J31KLabChemicalIDCode:N/AMRIAssignedBatchNo.:01InternalTaskNo.:792AmountReceived:8×1-gallonplasticjugsETPTaskNo.:CHEM02363SampleReceiptDate:12/05/1996ProgramSupported:GPSAppearance:Clear,colorlessliquidAnalysisDates:12/13-20/1996StorageConditions:Amb
3、ientInitiationDate:12/12/1996Vendor:McCormickDistillingCo.,Inc.InterimResultDate:N/AVendorPurity:95%StructureMolecularWeightMolecularFormulaH3CCH2OH46.07C2H6OQualityAssuranceStatementDoseVehicleAnalysisofEthanolETPTaskNo.CHEM02363MRIProjectNo.4300MRITaskNo.792ThisstudywasinspectedbytheQualityAssur
4、anceUnitofMRI(QAU)andthefindingsreportedtotheStudyDirectorandManagementasfollows:PhaseInspectedDateInspectedDateReportedProtocolAudit12/17/199612/18/1996In-lifeAudit,GCPurityAssessment12/17/199612/18/1996DataAudit1/24/19971/24/1997ReportAudit1/24/19971/24/1997Thisreportreflectstheproceduresandrawd
5、atageneratedinthisstudy.TherawdataandreportwillbestoredintheMRIArchives.Inadditiontothestudy-specificaudits/inspectionscitedabove,inspectionsoftheapplicablefacilitiesandequipmentwereperformedbytheQAUandreportsweresubmittedtomanagementasfollows:Facility/EquipmentInspectionDateManagementSubmittalDat
6、ePCALaboratoryComplex7/31/19968/2/1996GasChromatographyFacility8/20/19968/26/1996MidwestResearchInstituteCarlosCastroSeniorQualityAssuranceOfficerApproved:EugeneG.Podrebarac,Ph.D.Manager,QualityAssuranceJanuary29,1997GoodLaboratoryPracticeComplianceStatementThisstudywasconductedincompliancewiththe
7、GoodLaboratoryPracticeregulationsoftheU.S.FoodandDrugAdministration(21CFR58).MichaelKozakStudyDirectorExecutiveSummaryThepurposeofthistaskwastoverifytheidentityandassessthepurityforasampleofethanol.Theidentityofe
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