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首页 仪器确认 附件5 自动滴定仪确认 中英文

仪器确认 附件5 自动滴定仪确认 中英文.doc

仪器确认 附件5 自动滴定仪确认 中英文

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简介:本文档为《仪器确认 附件5 自动滴定仪确认 中英文doc》,可适用于战略管理领域,主题内容包含仪器确认附件自动滴定仪确认中英文PAPHOMCL()ROMCLGuidelineonautomatictitrators(Annex)OMCLNet符等。

仪器确认附件自动滴定仪确认中英文PAPHOMCL()ROMCLGuidelineonautomatictitrators(Annex)OMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENT质量管理文件PAPHOMCL()RQUALIFICATIONOFEQUIPMENT质器的质确ANNEX:QUALIFICATIONOFAUTOMATICTITRATORS附件,自质滴定质的质确FulldocumenttitleandreferenceQualificationofEquipment质器的质确文件全名和考文参献Annex:Qualificationofautomatictitrators附件,自质滴定质的质确PAPHOMCL()RDocumenttypeGuideline文件质型指南LegislativebasisThepreviousversionofthisdocumentwasalsoacceptedbyEAas立法基质recommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoptionJune首次采用日期Dateoforiginalentryintoforce初August版生效日期DateofentryintoforceofrevisedstMaydocument修质本生效日期PrevioustitlesotherThisdocumentreplacesdocumentPAPHOMCL()RReferences本文件替代文件PAPHOMCL()R曾用名其考文它参献CustodianOrganisationThepresentdocumentwaselaboratedbytheOMCLNetwork管理机构EDQMoftheCouncilofEuropeConcernedNetworkGEON相质质网ANNEXOFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”网确质指南“质器质”附件OMCLQUALIFICATIONOFAUTOMATICTITRATORS自质滴定质的质确介质IntroductionthThepresentdocumentistheAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingthequalificationprocessofautomatictitrators本文件质核心文件“质器的质”的第确个划确将附件~在质质、质施和质质自质滴定质的质质程中~质本文件核心文件一起使用。与ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,whicharecommontoalltypeofinstruments核心文件包括第一质和第二质质的介质和通用表格~适用于所有质型的质器。确Itisrecommended,atLevelIIofqualificationoftheautomatictitrators(Installationandreleaseforuse),toperformagravimetrictestofthevolumes(selectedvolumesinarandomwayfromtoofthecylindervolume)建质在自质滴定质的第二质质中安和使用放行,~质质质行重量质质滴定管确装体体随质质机质质个,。ThepresentannexcontainsinstrumentrelatedrecommendationsonparameterstobecheckedatLevelIIIandIVofqualificationandthecorrespondingtypicalacceptancelimits,aswellaspracticalexamplesonthemethodologythatcanbeusedtocarryoutthesechecks所附文件包括质器相质的推~在第三质和第四质质质质质何各~以及典型的可接受质准~质有与荐确参数可以用于质施质些质质的质质例。践表TABLEIIILevelIIIPeriodicandmotivatedinstrumentchecks第三质周期性主质质器质质Examplesofrequirementsforautomatictitrators自质滴定质要求质例质位滴定质欧洲质典(PhEur)POTENTIOMETRICTITRATORSParametertobecheckedTypicaltolerancelimits要质质的参数典型可接受限度Precision精密度RSDAccuracy准度确drelLinearity质性rKARLFISCHERVOLUMETRICTITRATORSusedforsemimicrodeterminationofwater卡质质休容量法滴定质~用于半微量水分质定卡欧质质休滴定~洲质典(KarlFischerTitration,PhEur)ParametertobecheckedTypicaltolerancelimits需要质质的参数典型可接受限度Precision精密度RSDLinearity(optional)质性可质质,rRecovery(optional)回收率可质质,to表质TABLEIII(cont)LevelIIIPeriodicandmotivatedinstrumentchecks第三质周期性质器质质Examplesofrequirementsforautomatictitrators(cont)自质滴定质要求质例KARLFISCHERCOULOMETRICTITRATORSusedformicrodeterminationofwater卡质质休质质滴定质~用于微量水分质定(CoulometricTitration,PhEur)质质滴定法~洲质典欧,ParametertobecheckedTypicaltolerancelimits需质质的参数典型可接受限度Precision精密度Standard质准μggHO:RSD质准StandardμggHO:RSDRecovery回收率Standard质准μggHO:to质准StandardμggHO:toLinearity(optional)质性rKARLFISCHEROVENusedformicrodeterminationofwaterusinganevaporationtechnique(CoulometricTitration,PhEur)卡炉欧质质休~用于蒸质技质质定微量水~质质滴定~洲质典,ParametertobecheckedTypicaltolerancelimits需要质质的参数典型可接受限度Temperatureaccuracy,温确度准性Temperaturestability温度质定性Carriergasflowrate质流速气mlminTABLEIVLevelIVInuseinstrumentchecks第四质次在用质器质质Examplesofrequirementsforautomatictitrators自质滴定质要求质例自质质位滴定质POTENTIOMETRICTITRATORSParametertobecheckedTypicaltolerancelimits需要质质的参数典型可接受质准Precision精密度RSDAccuracy准度确drel卡质质休容量法滴定质KARLFISCHERVOLUMETRICTITRATORSParametertobecheckedTypicaltolerancelimits需要质质的参数典型可接受质准Precision精密度RSDRecovery准度确to卡质质休质质法滴定质KARLFISCHERCOULOMETRICTITRATORSParametertobecheckedTypicaltolerancelimits需要质质的参数典型可接受质准Recovery回收率Standard质准μggHO:to质准StandardμggHO:to附件ANNEXILevelIIIPeriodicandmotivatedinstrumentchecks第三质周期性主质质器质质ThisAnnexcontainspracticalexamplesoftestsandtheirassociatedtolerancelimitsforseveralparametersrelatedtotheperformanceofautomatictitrators本附件包括了质质的质性例子~及其相质的自质滴定质性能相质的的可接受质准。践几个与参数TheseexamplescanbeconsideredbytheOMCLsaspossibleapproachestoperformtheLevelIIIoftheequipmentqualificationprocess:“Periodicandmotivatedinstrumentchecks”质些例子可以被质质是质器第三质质质“周期性主质质器质质”的方法。确OMCL质考质体GENERALCONSIDERATIONSDuetothefactthataholisticapproachhasbeentaken,theverificationoftemperatureprobesandburettesisnotincludedinthisguideline,astheperformanceoftheseitemsisindirectlycheckedduringtheaccuracytest由于采用了整合功能的质方法~本指南未包括度探质和滴定管的质~因质在准度质质中确温确确~上述质已质质接地被质质了。两Ifavailable,theinternalstartuptestfunctionmaybeusedeachtimetheinstrumentisswitchedon如果可以的质~质器置质机质质功能在每次质机质可以使用。内Ifseveralexchangeunitsareusedfordifferenttitrants,allunitsshouldbetestedatLevelIII如果有滴定质元用于不同的滴定质~所有质元在第几个质均需要质质。IIIThelimitsandspecificationsofthisguidelinehavebeensetaccordingtoMetrohmdocumentationForothermanufacturers(egMettlerToledo,Mitsubishi,etc)thespecificationsmayslightlydiffer本指南的限度和质准根据万通相质文质行质定。质于其生质商例如梅特勒献它托利多、三菱等,~质准可能稍有不同。质位滴定质POTENTIOMETRICTITRATORS精密度PRECISION材料Materials:SuitablecertifiedstandardRV(highlypure,dried),egBenzoicacidRVortris(hydroxymethyl)aminomethane(TRIS)合适的质准品高质~干燥,~例如甲酸苯或三质甲基氨基甲质,RVRV()TRISFreshtitrant,appropriatetotitratetheselectedstandard质休滴定质~适宜滴定质质的质准方法Method:Performaminimumoftitrationswithindependentadditionsofcertifiedstandard(inrandomorderifusingdifferentweights),whichshouldresultinaconsumptionofapproxtooftheburettevolume独立加入次质量质的质准物质如果重量不同的质~质序可以机,~质行至少随次滴定~消耗的滴定质的质质控制在一管质的体体。Note:Ifnecessary,forlowervolumeburettes,increasethemolarityofthetitrant(forexample,fromtoM)tominimizetheweighingerrorofthestandard注,如有必要~质于小容量滴管~增加滴定质的质度如从增加到,以少质准的量质差减称。MCalculatetherelativestandarddeviationofthetitersobtained质算所得的滴定度的相质质准偏差,。RSDIfavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument如果可以的质~质质算可以由质器的置质质功能质算得到。内Limits:RSD限度,RSD准度确ACCURACY材料Materials:参照第章精密度RefertochapterPrecisionTheaccuracyoftheresultsobtaineddependsonthecontentofthecertifiedstandardguaranteedbyitsmanufacturer所得质果的准性依质于质准物质供质商所保质的含量。确Calculationofthetheoreticaltitervalueasafunctionoftemperature:质滴定度受度影的质算温响Thetheoreticaltitervalueofthetitrantsolutionatis,withareductioninthetiterofperdegreeoftemperaturerise,accordingtothefollowingformula:滴定质溶液在质理质滴定度质~根据以下公式质行质算~每升高一度~质滴定度下降会。theoreticalXTiter(at)=(–x)理质滴定度在度质,,X=X其中Where:x=meanoftheinitialandfinaltemperatureofthetitrantsolution(atthebeginningandattheendofthemeasurement),inC滴定质溶液起始和质束度在质量质始和质束质,~温X=Note:Thestatedformulaisonlyapplicableforaqueoustitrantsolutions(seeApplicationBulletinNo,Metrohm)Forexample,thegivenreductioninthetiterofPerchloricacidisperdegreeoftemperaturerise注,所质定的公式只用于水相滴定溶液质第号质用公告~万通,。例如~高质酸滴定液质定的温数度膨质系质每升高一度~质度降低。方法Method:Performaminimumoftitrationswithdifferentweightsofcertifiedstandard称份量三质准物质~质行至少三次滴定。Note:Resultsfromtheprecisiontest(see)canbeused注,可以采用精密度质质质,的据。数Calculatethemeanofthetitersobtained质算滴定度的平均质。relCalculatethesystematicdeviation(d)withthefollowingformula:用以下公式质算系质质差,dreld=titertiterrelmean,theoreticaltitertheoretical,Ifavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument如果可以的质~质质算可以由质器的置质质功能质算得到。内限度Limits:relThesystematicdeviation(d)shouldbemaximum(whenusingafreshlyopenedtitrantcontainer)系质质差质如果使用新质的滴定质的质,质性LINEARITY材料Materials:参质第章精密度RefertochapterPrecisionMethod:Linearregressionvolumesamplesize方法,质性回质质体质品量Calculatealinearregressionofthetitrantvolumeinml(ycoordinate),versustheweightofthecertifiedstandarding(xcoordinate)onaminimumofweights以滴定质体,质质~质质准品重量,质质质算质性回质方程式~至少需要五重量据。个数mlygxLimits:r限度,rNote:Inaddition,usingthesamelinearitydata,systematicerrorscanbeevaluated,astheysysaxisinterceptofthelinearregressionTitrantvolumeinmlSamplesizeing(a),andtheTVolslopeofthelinearregressionTiterinMTitrantvolumeinml(b)注,外~如果使用相同的质性据~可以质系质质质~因质另数估质截距质滴定质体,质品ymlsysTVol重量,~质性回质的斜率质滴定度,滴定质体,。g(a)Mml(b)限度Limits:<a<lformlburettesalfor,,andmlburettesμμsyssys滴定管,~、、和滴定管,<mla<lmlalμμsyssysb<mlTVol卡质质休,容量法滴定质KARLFISCHER(KF)VOLUMETRICTITRATORSKF卡荐质质休滴定常质推GENERALRECOMMENDATIONSFORKFTITRATIONSItisrecommendedtoworkwithcertifiedwaterstandardsolutionsforwaterdetermination,withexactlyknownwatercontents,egHYDRANALSolidsubstances,suchasdisodiumtartratedihydrate,canalsobeused推使用质质质量的水质准溶液质质水含量~质的水含量质准已知~例如荐来它确~HYDRANAL也可以使用固质准物质~例如酒石酸二质二水合物。体KFinstrumentsshouldnotbelocatedinroomsthataresubjecttolargevariationsoftemperature,orclosetorefrigeratorsorradiatorsAprotectionshouldbeinstallediftheyarelocatedclosetowaterbathsorsinks,orindirectsunlight卡温冰质质休质器不质放置在差质大的房质~或接近箱、有质射源的地方。如果附近有水源、水池或直接光照~质加以保质。精密度PRECISION材料Materials:CertifiedwaterstandardsolutionwithadefinedguaranteedwatercontentsofmggKarlFischerreagentsforvolumetricwaterdetermination卡质质休质质,用于容量法质定水分Note:Thedryingtubeofthetitrationcellmustbefilledwithfreshmolecularsieve注,滴定质元需要干燥~充新质分子质。填方法Method:Performaminimumoftitrationswithindependentadditionsofwaterstandardsolution(inrandomorderifusingdifferentweights),whichshouldresultinaconsumptionofapproxtooftheburettevolume用至少份独随立的水质准溶液如果重量不同的质质序可以机,质行至少六次滴定~控制消耗的滴定液质质一管的体至。Calculatetherelativestandarddeviationofthetitersobtained质算所得滴定度的相质质准偏差,。RSDIfavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument如果可以的质~质质算可以由质器置的质质功能直接质算得到。内DLimits:RS限度,DRS质性可质质,LINEARITY(optional)材料Materials:RefertochapterPrecision参质第章~精密度Method:Linearregressionvolumesamplesize方法,质性回质质体质品量Calculatealinearregressionofthetitrantvolumeinml(ycoordinate),versustheweightofthecertifiedstandarding(xcoordinate)onaminimumofweights以滴定质体,质质~质质准品重量,质质质算质性回质方程式~至少需要五重量据。个数mlygxLimits:r限度,r回收率RECOVERY材料Materials:参质第章~精密度RefertochapterPrecision方法Method:PerformaminimumofinjectionswithanaccuratelyweighedamountofwaterstandardandperformthetitrationCalculatethemeanpercentagerecovery(r)ofwaterfromthewaterstandard,usingthefollowingformula:用精密量的水质准至少质称个质~滴定~用以下公式质算回收率的平均质。其中Where:百分比回收率r:percentagerecovery加入的水的重量~W:amountofwateradded,inmgmg质质水的重量~W:amountofwaterfound,inmgmgLimits:to限度,至卡质质休质质法滴定质KARLFISCHERCOULOMETRICTITRATORS精密度PRECISION材料Materials:Certifiedstandardsolution(highlypure,stable)withexactlyknownwatercontent:ggorμggμ质准物质高质度~质定,~水含量已知质或ggggμμKarlFischerreagentsforcoulometry用于质质法的质质休质质卡方法Method:Performaminimumofdeterminationswithindependentadditionsofwaterstandardsolution(inrandomorderifusingdifferentweights),betweenandgforawaterstandardsolutiongg,andbetweenandgforawaterstandardsolutionggμμ用至少份独随立的水质准溶液如果重量不同的质质序可以机,质行至少六次滴定~水质准溶液称质量~水质准称质量质。ggggggμμCalculatetherelativestandarddeviationofthewatercontentsfound(inμgg)质算质质水含量,相质质准偏差。μggIfavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument可以采用质器置的质质功能质行质质质算。内限度Limits:DWaterstandardsolutiongg:RSμ水质准溶液Dgg:RSμWaterstandardsolutiongg:RSDμ水质准溶液gg:RSDμ回收率RECOVERYThedeterminationoftherecoveryisbaseduponthewatercontentofthestandardguaranteedbythemanufacturer回收率的质算基于水质准供质商所申明的水含量。材料Materials:参质第章精密度RefertochapterPrecision方法Method:PerformaminimumofinjectionswithanaccuratelyweighedamountofwaterstandardandperformthecoulometrictitrationCalculatethemeanpercentagerecovery(r)ofwaterfromthewaterstandard,usingthefollowingformula:取水质准精密定~质校至少称次~作质质法滴定~用以下公式质算水质准的回收率的平均质。r=WW其中Where:百分比回收率r:percentagerecovery加入水的量数~:amountofwateradded,inmgmgW质质得水的量数~W:amountofwaterfound,inmgmg限度Limits:WaterstandardsolutionggRecovery:toμ水质准溶液回收率gg–:toμWaterstandardsolutionggRecovery:toμ水质准溶液回收率gg–:toμ质性可质质,LINEARITY(optional)材料Materials:参质第章~精密度RefertochapterPrecision方法Method:Calculatetheregressionlineoftheamountofwaterfounding(ycoordinate),versusthesampleμsizeing(xcoordinate)以质质水含量,质质~质质品重量,质质质算质性回质系。数gygxμLimits:r限度,r卡温炉质质休高KARLFISCHEROVENThefollowingtestsmaybeperformedincasetheKarlFischertitrator(volumetricorcoulometric)iscoupledtoanoven如果质质休滴定质容量法或质质法,配置了高~质质行下列质质卡温炉温度精密度TEMPERATUREACCURACY材料Materials:Calibratedtemperatureprobe质质校正的度探质。温方法Method:SettheoventemperatureatCWaituntilthesystemisequilibrated将炉温质定质~待系质平衡。Bymeansofthecalibratedprobe,measuretheactualtemperatureintheoven(alwaysinthesameposition)andcompareittothetemperaturedisplayedbytheoven用校正质的度探质~质量质质度保持在同一位置,~高的质质质示度质行比质。温炉内温与温炉温限度Limits:TheactualtemperaturemaynotdiffermorethanCwithrespecttothesettemperature质质度质定度差质不质大于温与温。C温度质定性TEMPERATURESTABILITY材料Materials:Calibratedtemperatureprobe校正质的度探质。温方法Method:SettheoventemperatureatCWaituntilthesystemisequilibrated将炉温质定质~待系质平衡。CInsertthecalibratedtemperatureprobeintotheovenblock(alwaysinthesameposition)Readtheinitialtemperatureandrepeatthereadingafterminutes将温插炉内温校正质的度探质入保持质在同一位置,。质取初始度~分质后再次质取度。温限度Limits:ThetemperatureafterminutesmaynotdiffermorethanCwithrespecttotheinitialtemperature分质后~质质度起始度差不得质温与温异。C质流速气CARRIERGASFLOWRATE材料Materials:Calibratedflowmeterorflowmeterusedinconnectionwithacalibratedwatch校正质的流量质或质接有校正质的秒表的流量质方法Method:Setthecarriergas(airorN)flowrateatmlminBymeansofthecalibratedflowmeter,measuretheactualflowrateandcompareittothesetvalue质定质流速空或,质气气氮气~用校正质的流量质质量质质流速~质定质质行比质。与mlmin限度Limits:nTheactualflowratemaynotdiffermorethamlminwithrespecttothesetflowrate质质流速质定流速差质不得质与异。mlmin附件ANNEXIILevelIVInuseinstrumentchecks第四质在用质器的质质ThisAnnexcontainspracticalexamplesoftestsandtheirassociatedtolerancelimitsforseveralparametersrelatedtotheperformanceofanautomatictitrator本附件包括了质质的质性例子~及其相质的自质滴定质性能相质的的可接受质准。践几个与参数TheseexamplescanbeconsideredbytheOMCLsaspossibleapproachestoperformtheLevelIVoftheequipmentqualificationprocess:“Inuseinstrumentchecks”质些例子可以被质质是质器第四质质质“在用质器质质”的方法。确OMCL质位滴定质POTENTIOMETRICTITRATORS精密度PRECISION材料Materials:SuitablecertifiedstandardRV(highlypure,dried),egBenzoicacidRVortris(hydroxymethyl)aminomethane(TRIS)适的质质质量的质准物质高质~干燥,~例如甲酸或三质甲基甲当苯胺,。TRISFreshtitrant,appropriatetotitratetheselectedstandard质休滴定质~适合滴定所质质的质准。方法Method:Performaminimumoftitrationswithindependentadditionsofcertifiedstandard(inrandomorderifusingdifferentweights),whichshouldresultinaconsumptionofapproxtooftheburettevolume采用质量质的质准物质质行次立加质如果使用的重量不同~质序可以机,~质行至少独随次滴定~滴定液消耗质质质一管的体。Calculatetherelativestandarddeviationofthetitersobtained质算所得滴定度的相质质准偏差。Ifavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument可以使用质器置的质质功能质行上述质算。内DLimits:RS限度,RSD准度确ACCURACY材料Materials:参质第章~精密度RefertochapterPrecision方法Method:CalculatethemeanofthetitersobtainedinchapterPrecision质算在第章~精密度中得到的滴定度的平均质。Forthecalculationofthetheoreticaltitervalueofthetitrantsolutionandthesystematicdeviationrel(d),refertoLevelIII,chapterPOTENTIOMETRICTITRATORSACCURACYrel质于滴定质溶液的理质滴定度质和系质性偏差的质算~质第参质~质位滴定质第章精密度。(d)III限度Limits:relThesystematicdeviation(d)shouldbemaximumofthetheoreticaltiter(determinedonafreshlyopenedtitrantcontainer)rel系质偏差质最大不超质理质滴定度的以新质的滴定质容器质准,。(d)Note:TheimplementationofthesuggestedlimitdependsonthequalityoftheusedvolumetricsolutionTheuseofanewsolutionandorthecheckofthetiterarerecommended注,所建质质行的可接受质准依质于所用的定量溶液的质量。建质使用新溶液和质质滴定度。KARLFISCHERVOLUMETRICTITRATORS卡质质休容量法滴定质PRECISION准度确Materials:材料Certifiedwaterstandardsolutionwithadefinedguaranteedwatercontentsofmgg质质质定的水质准溶液~水含量。mggKarlFischerreagentsforvolumetricwaterdetermination用于质质法质定水分的质质休质质。卡Method:方法Performaminimumoftitrationswithindependentadditionsofwaterstandardsolution(inrandomorderifusingdifferentweights),whichshouldresultinaconsumptionofapproxtooftheburettevolume用水质准溶液次立质质~质行至少独次滴定如果质准溶液重量不同~质质质序可以机,~滴定消随耗的滴定质质质一管的体。Calculatetherelativestandarddeviationofthetitersobtained质算所得的滴定度的相质质准偏差。Ifavailable,thiscalculationcanbeperformeddirectlywiththebuiltinstatisticsfunctionoftheinstrument如果可以的质~质质算可以由质器置的质质功能直接质算得到。内Limits:RSD限度:RSD回收率RECOVERYMaterialsandMethod:材料和方法RefertoRecoverytestinLevelIII参质第质质回收率质质III限度Limits:to限度:toKARLFISCHERCOULOMETRICTITRATORS卡质质休质质法滴定质RECOVERY回收率MaterialsandMethod:材料和方法RefertoRecoverytestinLevelIII参质第质质回收率质度IIILimits:限度WaterstandardsolutionggRecovery:toμ水质准溶液回收率gg–:toμWaterstandardsolutionggRecovery:toμ水质准溶液回收率gg–:toμ参献考文REFERENCES所有的考文均质采用质行版本参献(Forallreferences,thelatestversionapplies)欧洲质典)PhEur(,))ApplicationBulletinNoValidationofMetrohmKFTitratorsaccordingtoGLPISO质用期刊第期万通质质休滴定质根据卡的质质~万通MetrohmGLPISO)ApplicationBulletinNoValidationofMetrohmtitrators(potentiometric)accordingto质用期刊第期依据的万通滴定质质位滴定,的质质~GLPISOMetrohmGLPISO万通)ApplicationBulletinNoValidationofMetrohmKFcoulometersusingStandardOperating质用期刊第期万通质质休质质法的质准卡操作程序~万通ProceduresMetrohm质用期刊第期万)ApplicationBulletinNo–ValidationofMetrohmburetsMetrohm通滴定管的质质~万通

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