USP天平41及1251中英对照.doc

USP天平41及1251中英对照 USP36天平（中英文）xx-12-1117:36:56|分类USP|标签|举报|字号大中小订阅Change toread:This chapterstates therequirements for balances used for materials that must be aurately weighed(see General Notices,8.20).Unless otherwisespecified,when substancesmust beaurately weighed,the weighingshall be performed using a balance that iscalibrated overthe operatingrange andmeets therequirements definedfor repeatability and auracy.For balancesused for other applications,the balancerepeatabilityandauracy should be mensuratewith therequirements forits use.本章说明了用于必须精密称定（参见凡例8.20）的物料称量的天平的要求。 除非另有说明，如果必须精密称定，则应采用在称量范围内经过校正，并且符合重复性和准确性要求的天平来称量。 对于其它用途的天平，天平的重复性和准确度应根据其用途要求来确定。 For discussionof thetheoretical basis of theserequirements,see generalinformation chapterWeighing onan AnalyticalBalance1251,which may be ahelpfulbut notmandatoryresource.关于这些要求的理论基础的讨论，参见凡例，可能会有帮助-但不是必须。 REPEATABILITY重复性Repeatability isassessed byweighing oest weightNLT10times.NOTEThe test weight must be within the balances operatingrange,but the weight neednot becalibrated.Because repeatability is virtuallyindependent of sample masswithin the balances capacity,use of a smalltest weight,which may be difficultto handle,is notrequired.重复性采用对一个重量测试不少于10次来评估。 【注-用于测试的重量必须是在天平的称量范围内，但该砝码是不需要校正的。 因为重复性实际上取决于天平称量能力内样品的重量，由于很小的砝码可能比较难操作，因此不一定必须使用很小的那个。 】Repeatability issatisfactory iftwo timesthe standard deviation of the weighedvalue,divided by the nominal value of the weightused,does not exceed0.10%.If the standard deviationobtained isless than0.41d,where dis thescale interval,replace thisstandard deviationwith0.41d.In thiscase,repeatability issatisfactory iftwo times0.41d,divided by the nominalvalue of the weightused,does not exceed0.10%.如果各次所称得的重量值的标准偏差的2倍，除以所用砝码的名义重量值，不超过0.10%，则认为重复性满足要求。 如果所得的标准偏差小于0.41d，这里d值是分度值，则采用0.41d替代该标准偏差。 这种情况下，如果0.41d的2倍，除以所用砝码的名义重复值，不超过0.10%，则认为重复性满足要求。 ACCURACY准确度The auracyof a balance issatisfactory if its weighing value,when testedwith asuitable weight(s),is within0.10%of the test weight value.如果采用一个适当的砝码，其称量值与标准值的差值在标准值的+/-0.10%以内，则认为天平的准确度满足要求。 A test weight issuitable ifit hasa massbetween5%and100%of the balances capacity.The test weights maximumpermissible error(mpe),or alternativelyits calibrationuncertainty,shall beNMT one-third of the appliedtest limit of the auracy test.适当的砝码是指其重量在天平的最大量程的5%-100%之间的重量。 测试用砝码的最大允许偏差（mpe），或其校正不确定度，应不超过所使用的准确度测试的检测限的1/3。 NOTEApplicable standardsare the following:ASTM E617(available from.astm)and OIMLR111(available from.oiml).【注-适用标准引用ASTM E617】2S(USP36)Auxiliary InformationPlease checkfor yourquestion in the FAQsbefore contactingUSP.USP36NF31Page53USP36NF31Supplement:No.2Page6136USP37使用分析天平称量（中英文）xx-12-3115:08:35|分类USP|标签|举报|字号大中小订阅WEIGHING ONAN ANALYTICALBALANCE使用分析天平称量自（本文件USP37-NF32，目前尚未实施，信息仅供参考）INTRODUCTION介绍Weighing isa frequentstep in analytical procedures,and the balance isan essentialpiece of laboratory equipment.The generalinformation describedhere appliesdirectly toelectronic balancesused in analytical procedures.Although manyportions of the chapterare applicableto allbalances,some areapplicable onlyto analytical balances.This chaptershould not be consideredall-inclusive,and othersources ofinformation(e.g.,the USNational Institutefor Scienceand Technologyand balancemanufacturers)maybeuseful andapplicable whenanalysts performa weighingoperation orimplement a weighing procedureiiiiii.The informationgiven inthis chapteris applicablenot onlyto balancesused formaterials that must be aurately weighed(see Balances41)but alsoto balancesused in all analyticalprocedures.称重在分析程序中是一个很频繁的操作，天平是化验室的基本设备。 这里的一般信息适用于在分析过程中使用的电子天平。 尽管本章节的一部分也适用于所有天平，一些仅适用于分析天平。 本章不应作为包括所有的文件，一些其它的信息（例如，美国国家科学技术研究所和天平生产商）可能也很有用，适用于化验员进行称量操作，或实施称重程序。 本章中给出的信息不仅适用于必须精密称定的物质（参见），同时也适用于所有分析过程中使用的天平。 QUALIFICATION确认Users shouldconsult AnalyticalInstrument Qualification1058,standard operating procedures,and remendationsfrom manufacturerswhen theydevise qualificationplans.用户在设计其确认计划时，应参考，标准操作规程，和生产商的推荐。 Installation安装The balances performancedepends on the conditionsof thefacility whereit is installed.Analysts shouldconsult informationprovided by the manufacturerbefore theyinstall abalance.天平的性能取决于其安装所处的环境。 在安装天平前，化验员应参考供应商给出的信息。 Support surface:The balance should be installed ona solid,level,nonmagic surfacethat minimizesthe transmissionof vibration(e.g.,a floor-mounted,granite weighbench).If ametallic supportsurface is used,the surface should begrounded in order toprevent thebuildup ofstatic electricity.支持台面天平应安装在坚固、水平、无磁场的平面，尽量减少震动传递（例如，安装在地板，花岗岩称重台）。 如果采用了金属的支持台面，表面应接地，以避免静电聚积。 Location:If possible,the balance should be located ina roomthat istemperature andhumidity controlled.The locationshould have a clean,consistent electricalpower supply.The locationshould befree ofdrafts and should notbe nearovens,furnaces,air conditionerducts,or coolingfans fromequipment orputers.位置如果可能，天平应安装在一个温湿度可控的房间。 位置应清洁，具有持续的电力供应。 位置应不会产生波动，不靠近烘箱、马弗炉、空调送回风罩，或设备、空调的冷却风扇。 The balanceshould bepositioned awayfrom outsidewindows sothat directsunlight does not strikethe balance.The balanceshould notbe installednear sourcesof electromagic radiation such as radiofrequencygenerators,electric motors,or hand-held municationdevices(including cordlesstelephones,cellular telephones,and walkie-talkies).The balanceshould notbelocated near magic fields induced by laboratoryinstrumentation orother equipment.天平位置应远离窗户，以避免直接阳光照射。 天平安装不应靠近电磁辐射源，如无线频率发向射源，电子马达，或手动通话设施（包括无绳电话、手机、手提无线电话机）。 天平不应安装在化验室设备或其它设备产生的磁场区域附近。 The performance of the balanceshould be assessedfollowing installationand before use in order todemonstrate adequateperformance.In somesituations,it may notbepossible toposition the balance inan optimumenvironment.Examples ofpotential facilityissues include thefollowing:天平的性能在安装后使用前应进行评估，以证明其性能符合要求。 在某些情况下，可能无法将天平安装在一个理想的环境。 潜在的设施问题包括以下1.Air currentssometimes arepresent in the laboratory.化验室中有时会有气流2.Temperatures in the laboratoryvary excessively(check the manufacturers literatureabout temperaturesensitivity).化验室温度有时会快速波动（检查供应商关于温度敏感性的说明）3.Humidity iseither verylow orvery high.Either conditionmay increasethe rateat which the sample weight variesbecause ofpickup orloss ofwater.Low humidityincreases thebuildup ofstatic electricity.湿度可能会很低或很高。 由于失水或吸水，太高或太低都会影响样品重量变动的速度。 低湿度会增加静电积聚。 4.Adjacent operationsare causingvibration.邻近操作产生震动5.Corrosive materialsare usednearby or are routinelyweighed.附近使用腐蚀性材料，或常规称量腐蚀性物料6.The balance is locatedwithin afume hoodbecause it is used to weighcorrosive orhazardous materials.由于天平用于称量腐蚀性或危险性物料，因此安装在排烟罩内7.The balanceis adjacentto equipmentthat producesa magicfield(e.g.,a magicstirrer).天平邻近产生磁场的设备（例如，电磁搅拌器）8.Direct sunlightstrikes the balance.天平有直接太阳光照In situationswhen the balanceislocatednearequipment orsystems thatinduce vibration,drafts,electromagicradiation,magicfields,or changesin temperatureor humidity,the assessmentshould beconducted withthose systemsoperating inorder toduplicate aworst-case scenario.如果天平位置接近产生震动、摆动、电磁辐射、磁场或温湿度变化的设备，则需要对这些系统在操作状态下进行评估，以重复最差情况环境。 Operational Qualification运行确认An operational qualification should be performedeither bythe useror bya qualifiedthird-party vendorafter theequipment hasbeen installed.在天平安装后，应由用户或第三方供应商进行运行确认。 As aminimum,the powershould beturned onand the balanceshould be allowedto equilibrateaording to the manufacturers instructions(124h,depending on the type of balance)before use.Depending on the balance,analysts shouldincludethefollowing proceduresin theoperational qualification:最低要求，要打开电源，根据生产商的要求，在使用前让天平平衡（1-24小时，根据型号不同而不同）。 根据天平型号，化验员应在运行确认中包括以下程序1.Mechanical mobilityof allmoveable parts所有可移动部件机械动态2.Control ofstable indication稳定指示的控制3.Manually triggered or automatic adjustment by means of built-in weights内置砝码的手动或自动调节4.Operation of ancillary equipment辅助设备的操作5.Tare function去皮功能6.Initial calibration初始校正Several typesof electronicanalyticalbalancesuse built-in weightsfor manuallytriggeredorautomaticadjustment.This adjustmentusually isapplied to reduce thedrift of the balanceover timeand topensate fordrifts caused by variationsin theambient temperature.一些电子分析天平使用内置砝码，可以进行手动或自动调节。 这种调节一般用于减少天平随时间的漂移，对由于周围产生震动引起的漂移进行补偿。 Calibration normallyis performedas partof theoperationalqualification,but italso can be performed periodically thereafter.Calibration should beperformed at thelocation wherethe balanceis usedin normaloperation.校正一般作为运行确认的一部分实施，但也可以在之后进行周期性校正。 校正应在天平所正常操作的原位进行。 Performance Qualification性能确认Table1provides alist of the mostimportant balanceproperties thatshould beassessed duringperformance qualification.Depending on the riskof theapplication and the required weighing processtolerance,some of these testsmaybeomitted.Tests also can beomitted if there isevidence that the propertyin questionhas onlyminimal effecton the weighing performance.Any proceduresused should be consistentwith in-house standardoperating procedures,applicable for the specificbalance,and adequatelyjustified.Performance qualificationshouldbeperformedperiodicallyas describedin standardoperating procedures,and thefrequency ofeach of the individualtests can vary depending onthecriticality of the property.表1提供了一个天平最重要属性的清单，在性能确认中应该进行评估。 根据应用的风险不同，要求的称重允差不同，有时该类测试可以省略。 如果有证据表明该属性仅对称量性能形成很小的影响，则也可以省略对其进行的测试。 任何所用的程序均应与公司内部，适用于该特定天平的标准操作规程一致，并应进行充分判定。 性能确认应按标准操作规程的描述周期实施，各测试的实施频率可能根据属性的关键程度不同而不同。 The weightsthat areused toperform the tests shouldbe storedand handledinamanner thatminimizes contamination.Before executingthe tests,the analystshould place the weightsinthevicinity of the balancefor an appropriate timeto reachsufficient thermalequilibrium.If possible,all testsshouldbecarried outwith asingle test weight inorder tominimize handlingerrors,but multipletest weightsare permitted.用于测试的砝码存贮和使用过程应能尽量减少污染。 在进行测试前，化验员应将砝码放置在天平附近一段时间，以使其温度达到与环境温度平衡。 如有可能，所有测试均应采用同一个砝码，以尽可能减少操作误差，但使用多个砝码也是允许的。 The testsshouldberecorded insuchamanner that the datacan be used toeasily trackbalance performanceand to assist inlaboratory investigationsas needed.Meaningful aeptance criteria canbe setdepending onthe requiredweighing tolerance,i.e.,the maximumallowed deviationpermitted byspecifications,regulations,etc.,of aquantity tobe weighedfrom itstarget value.Procedures shouldbein place to address testresults thatare outside aeptable rangesand toprovide assurancethat balancecleanliness andenvironment havenot affectedthe result.Also,a procedureshouldbeinplacefor removingabalancefrom operationwhen observed results falloutsideaeptableranges.测试过程要进行记录，数据应能很容易地追踪到天平性能，帮助化验室进行必要的调查。 根据要求的称重误差，即质量标准、法规等允许的与目标重量值的最大允差，可以设定实际的可接受标准。 应有程序说明测试超出可接受范围的结果，并保证天平的清洁和环境不会对结果产生影响。 应有程序说明如果观察到结果超出可接受标准，则天平则不能继续使用。 Table1.Suggested PerformanceTests andAeptance Criteria表表1.推荐性能确认测试和可接受标准Property属性Definition定义Examples举例Aeptance Criteria可接受标准Sensitivity Changein weighingvalue divided bythechange inload,usually measuredbetween zeroand the capacity of the balance.The testload ator sufficientlyclose to the capacity of the balance.NMT0.05%deviation where41is applicable.For otheruses,respective tolerancerequirement divided by2.灵敏度称量值变动值除以载重变动值，一般在零点和天平最大载荷间测量测试载重接近天平最大载荷如果适用，则0.05%偏差其它情况，以相应的要求允差除以2Linearity Abilityof abalance tofollow thelinear relationshipbetween aload and the indicatedweighingvalue.Nonlinearity usuallyis expressedas thelargest magnitudeof anylinearity deviationwithin the test interval.From3to6points overthe rangeof the balance.NMT0.05%deviation where41is applicable.For otheruses,respective tolerancerequirement dividedby2.线性天平在载重和指示的重量之间保持线性关系的能力。 非线性一般表达为在测试间隔内的任何线性偏差的最大级别天平范围内从3-6点如果适用，则0.05%偏差其它情况，以相应的要求允差除以2Eentricity Deviationinthemeasurement valuecausedbyeentric loadingin otherwords,the asymmetricalplacement of the centerof gravityof theload relativeto theload receiver.Performed inthe centerof gravityand thefour quadrants(for rectangularplatter shapes)or atanalogous locationsforotherplatter shapes.Test loadNMT0.05%deviation where41is applicable.For otheruses,respective tolerancerequirement dividedby2.Eentricity usuallyis expressedas thelargest magnitudeof anyof thedeviations betweenan off-center readingand thecenter readingfor agiven testload.usually shouldbe30%of thecapacity of the balanceor higher(refer to themanufacturers manualfor anypossible upperlimit).偏心率由于偏心载重引起的测量值的偏差，换句话说，载重盘中心荷载不均匀。 偏心率一般表达为对一个给定的载重，非中心放置时读数与中心放置时的读数的偏差最大级别。 测量四角称量值（四边形称量盘）或其它形状称量盘类似的位置。 测试用载重一般为天平最大载重量的30%，或更高（参见供应商手册中建议的可用最高限值）如果适用，则0.05%偏差其它情况，以相应的要求允差除以2Repeatability Abilityof aweighing instrumentto displayidentical measurementvalues forrepeated weighingsof the same objectsunder the same conditions,e.g.,thesamemeasurement procedure,same operator,same measuringsystem,same operatingconditions,and samelocation overa shortperiod oftime.Repeatability usuallyis expressedas thestandard deviation of multipleweighings.10replicate weighings(usingatest weight that isa few percent of the nominalcapacity of thebalance).Requirement from41where applicable.For otheruses,user specifiedrequirements willapply.重复性在相同条件下，一个称重设备对同一物体的重复称重显示同一测量值的能力，例如，采用同样的称量很多种，同样操作者，同一测量系统，同一操作条件，同一位置在较短时间内。 重复性一般表达为重复称量的标准偏差。 10次重复称量（采用天平名义载重能力的百分之几的测试砝码）如果适用，则按照要求。 其它情况，用户指定适用的要求Sensitivity,linearity,and eentricityall aount for systematic deviations;i.e.,they limitthe auracyof thebalance(based onthe definitionof auracyin Validationof CompendialProcedures1225and ICH Q2).In theInternational Vocabularyof Metrology(VIM)and documentsof theInternational Organizationfor Standardization,this conceptis referredtoastrueness.Because deviations are largelyindependent fromeach other,itis not likelythat alldeviations oursimultaneously andhave thesame algebraicsign.灵敏度、线性和偏心率均为系统性误差，即它们会局限天平的精密度（基于精密度定义，和ICHQ2）。 在国际计量词汇（VIM）中，和国际标准化组织文件中，本根据被引用为真实性。 因为偏差很大程度上相互独立，因此不可能所有偏差同时产生，并具有同向性（即同时正负）。 Therefore thearithmetic addition of allindividual deviationsto assessthebalanceauracy wouldconstitute arather conservativeapproach.A quadraticadditionofthe individualdeviations isa morerealistic approach.By allocating50%ofthe weighing tolerancebudget to the aeptance criteria ofthe individualproperties,e.g.,sensitivity,linearity,and eentricity,analysts ensureadherence tothe requiredweighing tolerance.Therefore,the aeptancecriteria for the individualproperties thataountfor the systematicdeviationsareset toweighing tolerancedividedby2.These propertiesorasubset ofthemalso canbe taken to fulfillthe auracyrequirement describedin41.In thiscase the aeptancecriteriathus allowa maximumdeviation of0.05%for sensitivity,linearity,and eentricity.Repeatability preferablyis testedwith atest weight of a fewpercent ofthebalance capacity.At the lower endof itsmeasurement range,the performanceoflaboratory balances is limited bythe finite repeatability,and limitationsinducedbysystematicdeviationsnormally canbe neglected.Therefore,the wholeweighing tolerancebudget canbe allocatedtothe aeptance criterionofthe repeatability test.因此，采用所有单个误差的算术加和，来评估天平的准确度是一种较为保守的方法。 采用单个偏差的二次加和是一种更现实的方法。 将各单个属性的可接受标准置为称量允差的50%，如，灵敏度、线性和偏心率，化验员可以保证达到所需的称量允差。 这样，单个属性的可接受标准作为系统误差设定为称量允差除以2。 这些属性-或属性的子集-也可以认为是满足中描述的精密度要求。 在这种情况下，可接受标准允许最大偏差为灵敏度、线性和偏心率的0.05%。 重复性最好采用一个天平最大载重量百分之几重量的砝码测试。 在测量范围的低值端，化验室天平的性能由有限次数重复性所限度，由系统误差引入的限度一般可以忽略。 因此，整个称量允差可以直接作为重复性测试的可接受标准。 For thesensitivity andlinearity testsas described above,the analystshould usecertified weightswith anappropriate weightclass(e.g.,aording toInternational Organizationof LegalMetrology R111or AmericanSociety forTesting andMaterials E617,available from.oiml and.astm,respectively).NOTEIf adifferential methodis used for thelinearity test,certified weightsmay notbe required.对于上述灵敏度和线性，化验员应使用具有适当重量分类（例如，根据国际法定计算组织R111或美国材料试验协会E617，可分别从上述网址获得）且认证过的砝码。 【注-如果使用了不同方法进行线性测试，认证过的砝码，可能不需要认证过的砝码】Depending onthe aeptancecriterion,it maybe sufficient to consideronly the nominal weight value ofthe testweights.If thenominalvalue ofthetestweight is considered,analysts shouldensure that the maximumpermissible errordoes notexceed one-third ofthe aeptancecriterion.Alternatively,ifthecertified valueofthetestweightis considered,its calibrationuncertainty should notexceed one-third oftheaeptancecriterion.If morethan oneweightisusedtoperform thetest,the calibrationuncertainties ofthe weightsmust besummed andthe sumshouldnotexceedone-third oftheaeptancecriterion.For testssuch aseentricity orrepeatability,the useof certifiedweights isoptional,but analysts must ensure that themass ofthe weightdoes notchange during thetest.根据可接受标准的不同，可能只需要考虑测试所用砝码的名义重量。 如果考虑的是名义值，化验员应保证最大允差不超过可接受标准的1/3。 相应的，如果考虑的是测试用砝码的校正值，则校正不确定度应不超过可接受标准的1/3。 如果使用了不止一个砝码，则校正砝码不确定度必须要进行加和，和值应不超过可接受标准的1/3。 对于偏心率或重复性，可以使用认证过的砝码，但化验员必须保证砝码的重量在测试期间不产生变化。 The testsdescribedabovealsocanbe includedin formalperiodic calibrationinorder to fulfillapplicable cGMPrequirements.上述测试也可以包括在正式的周期性校正中，以满足所实施的cGMP的要求。 Balance Checks天平检查A balance check usingan external weight helpsensurethatthebalancemeets weighing tolerance requirements.The balance check isperformedatappropriate intervalsbased onapplicable standardoperatingprocedures.The frequencyofthebalancecheckdepends onthe riskoftheapplication andthe requiredweighing tolerance.Checks withexternal weightscanbe replaced partiallyusing automaticor manuallytriggered adjustmentbymeansofbuilt-in weights.When analystsperform thebalancecheckwith anexternalweight,thesameaeptancecriteriamay applyas describedinthesensitivity testabove.对天平采用外部砝码进行检查，可以保证天平符合称重允差要求。 根据所要求的标准操作规程，可以采用适当的间隔进行天平检查。 检查频率取决于使用的风险，以及称重允差要求。 采用外部砝码进行检查可以部分采用自动或手动内置砝码调节功能代替。 如果化验室采用外部砝码进行检查时，适用上述灵敏度测试相同的可接受标准。 Minimum Weight最小称样量The minimum sample weight,mmin,of