美国药典凡例中英文-USP32-NF27-General-Notice

USP32-NF27GeneralNotices凡例USP32............................................................................................................................2Introduction简介..........................................................................................................24.MONOGRAPHSANDGENERALCHAPTERS正文和附录.............................35.MONOGRAPHCOMPONENTS专论构成............................................................76.TESTINGPRACTICESANDPROCEDURES试验规范和过程....................187.TESTRESULTS测试结果..................................................................................288.TERMSANDDEFINITIONS术语及定义.........................................................319.PRESCRIBINGANDDISPENSING开方和配方..............................................4110.PRESERVATION,PACKAGING,STORAGE,ANDLABELING防腐，包装，贮藏和标签......................................................................................................................42NF27............................................................................................................................66Introduction简介....................................................................................................66TITLE标题..............................................................................................................67“OFFICIAL”AND“OFFICIALARTICLES”“药典的”和“药典药物”....................68STORAGEUNDERNONSPECIFICCONDITIONS非特定条件下的贮存..........70OTHERGENERALNOTICES其他凡例.................................................................71USP32Introduction简介GENERALNOTICESANDREQUIREMENTS凡例和要求Changetoread:TheGeneralNoticesandRequirementssection(theGeneralNotices)presentsthebasicassumptions,definitions,anddefaultconditionsfortheinterpretationandapplicationoftheUnitedStatesPharmacopeia(USP)andtheNationalFormulary(NF).凡例和要求部分（凡例）给出对USP和NF中假设、定义、默认条件的解释和应用。RequirementsstatedintheseGeneralNoticesapplytoallarticlesrecognizedintheUSPandNF(the“compendia”)andtoallgeneralchaptersunlessspecificallystatedotherwise.WheretherequirementsofanindividualmonographdifferfromtheGeneralNoticesorageneralchapter,themonographrequirementsapplyandsupersedetherequirementsoftheGeneralNoticesorthegeneralchapter,whetherornotthemonographexplicitlystatesthedifference.除另有规定外，凡例中的要求应用于所有USP和NF公认的(即药典的)药品，也适用于所有附录。如果专论的要求与凡例或附录要求不同，无论专论是否说明改差别，都应使用专论要求取代凡例或附录的要求。4.MONOGRAPHSANDGENERALCHAPTERS正文和附录4.10Monographs专论Monographssetforththearticle'sname,definition,specification,andotherrequirementsrelatedtopackaging,storage,andlabeling.Thespecificationconsistsoftests,procedures,andacceptancecriteriathathelpensuretheidentity,strength,quality,andpurityofthearticle.Forgeneralrequirementsrelatingtospecificmonographsections,seesection5,MonographComponents.专论阐述了药品的名称，定义，质量 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，及其他和包装，储存和标签相关的要求。质量标准包括测试，过程，及可接受范围，保证了药品的特性，规格，质量和纯度。对于特定专论相关的一般要求，参见章节5“专论构成”。Becausemonographsmaynotprovidestandardsforallrelevantcharacteristics,someofficialsubstancesmayconformtotheUSPorNFstandardbutdifferwithregardtononstandardizedpropertiesthatarerelevanttotheiruseinspecificpreparations.Toassureinterchangeabilityinsuchinstances,usersmaywishtoascertainfunctionalequivalenceordeterminesuchcharacteristicsbeforeuse.由于专论可能无法提供全部特性的标准，有些药物可能符合USP或NF标准，但是其在特定的制备中使用的相关非标准性质可能有所不同。为确保这个情况的互通性，使用者在使用前须确定其功能对等或确定其特征。4.10.10ApplicabilityofTestProcedures测试过程的适用性Asinglemonographmayincludeseveraldifferenttests,procedures,and/oracceptancecriteriathatreflectattributesofdifferentmanufacturers'articles.Suchalternativesmaybepresentedfordifferentpolymorphicforms,impurities,hydrates,anddissolutioncases.Monographsindicatethetests,procedures,and/oracceptancecriteriatobeusedandtherequiredlabeling.单个专论中可能包括几个测试，过程，和/或验收标准，来反映不同的厂商药品的特性。其中可能包括不同的多晶型，杂质，水合物，和溶出度等。专论涉及到使用的测试，过程，和/或验收标准，和需要的标签。4.10.20AcceptanceCriteria验收标准Theacceptancecriteriaallowforanalyticalerror,forunavoidablevariationsinmanufacturingandcompounding,andfordeteriorationtoanextentconsideredacceptableunderpracticalconditions.Theexistenceofcompendialacceptancecriteriadoesnotconstituteabasisforaclaimthatanofficialsubstancethatmorenearlyapproaches100percentpurity“exceeds”compendialquality.Similarly,thefactthatanarticlehasbeenpreparedtotightercriteriathanthosespecifiedinthemonographdoesnotconstituteabasisforaclaimthatthearticle“exceeds”thecompendialrequirements.验收标准允许 分析 定性数据统计分析pdf销售业绩分析模板建筑结构震害分析销售进度分析表京东商城竞争战略分析 误差、生产中不可能避免的变化，及根据实际情况在一定可接受范围内调整。药典标准的存在并不说明一个药物接近100%纯度就是超过了药典质量标准。同样的，如果一个药品按照比专论更严格的标准制备也不能说明该药品超过了药典质量标准。Anofficialproductshallbeformulatedwiththeintenttoprovide100percentofthequantityofeachingredientdeclaredonthelabel.Wheretheminimumamountofasubstancepresentinadietarysupplementisrequiredbylawtobehigherthantheloweracceptancecriterionallowedforinthemonograph,theupperacceptancecriterioncontainedinthemonographmaybeincreasedbyacorrespondingamount.一个药品必须100%保证其标签上所有成分的质量。当法律要求食品添加剂中某一成分使用最小量，标准比专论允许的较低标准要高，这时专论中较高的验收标准需做相应的提高。Theacceptancecriteriaspecifiedinindividualmonographsandinthegeneralchaptersforcompoundedpreparationsarebasedonsuchattributesofqualityasmightbeexpectedtocharacterizeanarticlecompoundedfromsuitablebulkdrugsubstancesandingredients,usingtheproceduresprovidedorrecognizedprinciplesofgoodcompoundingpractice,asdescribedinthesecompendia.专论和附录中复方制剂的验收标准，是基于这样的质量特性：这些质量特性可能用于检测由适当原辅料制备得到的制剂，并采用药物混合操作提供的规程或公认 规则 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，如药典阐述的。4.20GeneralChapters附录Eachgeneralchapterisassignedanumberthatappearsinanglebracketsadjacenttothechaptername(e.g.,Chromatography<621>).Generalchaptersmaycontainthefollowing:•Descriptionsoftestsandproceduresforapplicationthroughindividualmonographs,•Descriptionsandspecificationsofconditionsandpracticesforpharmaceuticalcompounding,•Generalinformationfortheinterpretationofthecompendialrequirements,•Descriptionsofgeneralpharmaceuticalstorage,dispensing,andpackagingpractices,or•Generalguidancetomanufacturersofofficialsubstancesorofficialproducts.每个附录标题旁边都有一个带尖括号的数字（如：色谱<621>），附录一般包括一下内容：z应用到正文中的测试和方法的说明；z药物混合的说明，条件要求和操作；z一般信息：药典标准的诠释；z一般药品的储存，分装和包装的说明；z对药典原料药或制剂生产商的指南。Whenageneralchapterisreferencedinamonograph,acceptancecriteriamaybepresentedafteracolon.如果正文中引用附录，其验收标准会出现在冒号后。Somechaptersmayserveasintroductoryoverviewsofatestorofanalyticaltechniques.Theymayreferenceothergeneralchaptersthatcontaintechniques,detailsoftheprocedures,and,attimes,acceptancecriteria.有些附录可能作是某个测试或分析技术的概述，其可能参考其他附录中的技术，过程细节，有时还有验收标准。5.MONOGRAPHCOMPONENTS专论构成5.10MolecularFormula分子式Theuseofthemolecularformulafortheactiveingredient(s)namedindefiningtherequiredstrengthofacompendialarticleisintendedtodesignatethechemicalentityorentities,asgiveninthecompletechemicalnameofthearticle,havingabsolute(100percent)purity.用于表示化学实体或实体的活性组分分子式的使用，是完整的化学名称，具有绝对（100%）的纯度。5.20.AddedSubstances,Excipients,andIngredients添加剂，辅料，和成分Substancesareregardedasunsuitableforinclusioninanofficialarticleandthereforeprohibitedunless:(1)theydonotexceedtheminimumquantityrequiredforprovidingtheirintendedeffect;(2)theirpresencedoesnotimpairthebioavailability,therapeuticefficacy,orsafetyoftheofficialarticle;and(3)theydonotinterferewiththeassaysandtestsprescribedfordeterminingcompliancewiththecompendialstandards.不适合用于药品的物质，则不能使用，除非以下情况：（1）其含量没有超过发挥其作用的最低限度；（2）其存在不会影响药品的生物利用度，疗效或安全性；（3）其不会影响药典标准的含量和测试要求。Theairinacontainerofanofficialarticlemay,whereappropriate,beevacuatedorbereplacedbycarbondioxide,helium,argon,ornitrogen,orbyamixtureofthesegases.Theuseofsuchgasneednotbedeclaredinthelabeling.药品包装中的空气，如果需要，可抽真空，或用二氧化碳，氦气，氩气，氮气，或这些气体的混合物替代。使用这些气体无需在标签中标明。5.20.10.AddedSubstances,Excipients,andIngredientsinOfficialSubstances药物的添加剂，辅料，和成分Officialsubstancesmaycontainonlythespecificaddedsubstancesthatarepermittedbytheindividualmonograph.Wheresuchadditionispermitted,thelabelshallindicatethename(s)andamount(s)ofanyaddedsubstance(s).药物可能只包含了专论允许的特定添加剂。如果添加剂是允许的，则标签上必须标明所有添加剂的名称和质量。5.20.20.AddedSubstances,Excipients,andIngredientsinOfficialProducts制剂的添加剂，辅料，和成分Suitablesubstancesandexcipientssuchasantimicrobialagents,pharmaceuticalbases,carriers,coatings,flavors,preservatives,stabilizers,andvehiclesmaybeaddedtoanofficialproducttoenhanceitsstability,usefulness,orelegance,ortofacilitateitspreparation,unlessotherwisespecifiedintheindividualmonograph.为增强制剂的稳定性，作用，或外观，或方便其制备，制剂中经常加入适当的成分和辅料，如抗菌剂，药物基质，载体，包衣辅料，香料，防腐剂，稳定剂和媒介物，除专论中另有规定外。Addedsubstancesandexcipientsemployedsolelytoimpartcolormaybeincorporatedintoofficialproductsotherthanthoseintendedforparenteralorophthalmicuse,inaccordancewiththeregulationspertainingtotheuseofcolorsissuedbytheU.S.FoodandDrugAdministration(FDA),providedsuchaddedsubstancesorexcipientsareotherwiseappropriateinallrespects.(SeealsoAddedSubstancesunderInjection<1>)根据美国FDA发布的关于着色剂使用的法规，除了注射剂或眼科制剂以外的制剂产品可以加入着色剂，只要加入物质符合各方面的要求（见“注射剂<1>”下的添加剂）Theproportionsofthesubstancesconstitutingthebaseinointmentandsuppositoryproductsandpreparationsmaybevariedtomaintainasuitableconsistencyunderdifferentclimaticconditions,providedthattheconcentrationsofactiveingredientsarenotvariedandprovidedthatthebioavailability,therapeuticefficacy,andsafetyofthepreparationarenotimpaired.为保证产品在不同的气候条件下的一致性，软膏和栓剂的基本处方比例和制备可进行适当调整，前提是活性成分的浓度不会改变，且制剂的生物利用度、疗效和安全性不会受影响。5.20.20.1.InCompoundedPreparations复方制剂Compoundedpreparationsforwhichacompletecompositionisgivenshallcontainonlytheingredientsnamedintheformulasunlessspecificallyexemptedhereinorintheindividualmonograph.Deviationfromthespecifiedprocessesormethodsofcompounding,althoughnotfromtheingredientsorproportionsthereof,mayoccurprovidedthatthefinishedpreparationconformstotherelevantstandardsandtopreparationsproducedbyfollowingthespecifiedprocess.对于有完整处方的复方制剂，在本文或专利没有特殊说明的情况下，只能包含处方上的成分。假如最终产品符合相关标准并按照指定工艺生产，尽管成分和比例相同，实际操作与指定工艺或方法仍可能存在一定偏差。Whereamonographforacompoundedpreparationcallsforaningredientinanamountexpressedonthedriedbasis,theingredientneednotbedriedbeforeuseifdueallowanceismadeforthewaterorothervolatilesubstancespresentinthequantitytaken.如果专论要求某一成分以干品计，若其取用量所含水分或其他挥发性物质有明确的允许范围，则不必在使用前预先干燥。SpeciallydenaturedalcoholformulasareavailableforuseinaccordancewithfederalstatutesandregulationsoftheInternalRevenueService.AsuitableformulaofspeciallydenaturedalcoholmaybesubstitutedforAlcoholinthemanufactureofofficialpreparationsintendedforinternalortopicaluse,providedthatthedenaturantisvolatileanddoesnotremaininthefinishedproduct.Apreparationthatisintendedfortopicalapplicationtotheskinmaycontainspeciallydenaturedalcohol,providedthatthedenaturantiseitherausualingredientinthepreparationorapermissibleaddedsubstance;ineithercasethedenaturantshallbeidentifiedonthelabelofthetopicalpreparation.Whereaprocessisgivenintheindividualmonograph,anypreparationcompoundedusingdenaturedalcoholshallbeidenticaltothatpreparedbythemonographprocess.根据美国国内税局的联邦法和相关规程，可以使用指定的变性乙醇。内用或外用的制剂生产过程可以使用指定的变性乙醇替代乙醇，只要变性剂是易挥发且不会在终产品中残留。外用皮肤制剂可含特定的变性乙醇，只要变性剂是普通制剂成分或允许添加物，或在标签上标示。只要是专论中给出了工艺，则使用了特定变性乙醇的制剂，必须与专论工艺生产出来的制剂一致。5.20.20.2.InDietarySupplements食品添加剂Additionalingredientsmaybeaddedtodietarysupplementproductsprovidedthattheadditionalingredients:(1)complywithapplicableregulatoryrequirements;and(2)donotinterferewiththeassaysandtestsprescribedfordeterminingcompliancewithcompendialstandards可在食品中加入添加剂，只要添加剂符合以下情况：（1）符合相关法规；（2）不影响药典标准的含量和测试要求。5.30.DescriptionandSolubility性状和溶解度Onlywhereaquantitativesolubilitytestisgiveninamonographandisdesignatedassuchisitatestforpurity.只有给出定量溶解度试验且指定内容时，方可用于纯度的检查。Amonographmayincludeinformationregardingthearticle'sdescription.Informationaboutanarticle's“descriptionandsolubility”alsoisprovidedinthereferencetableDescriptionandRelativeSolubilityofUSPandNFArticles.Thereferencetablemerelydenotesthepropertiesofarticlesthatcomplywithmonographstandards.Thereferencetableisintendedprimarilyforthosewhouse,prepare,anddispensedrugsand/orrelatedarticles.Althoughtheinformationprovidedinmonographsandtheinformationinthereferencetablemayindirectlyassistinthepreliminaryevaluationofanarticle,itisnotintendedtoserveasastandardortestforpurity.专论中可能包含药品性状的信息。参考表中也有“性状和溶解度”的信息和USP/NF产品相对溶解度。参考表只提供符合专论标准的药品特性。参考表主要用于使用，制备，分装药品和相关物品。尽管专论和参考表提供的信息可间接作为初步评估药品的参考，但并不能作为纯度的检测和标准。Theapproximatesolubilityofacompendialsubstanceisindicatedbyoneofthefollowingdescriptiveterms:原料药可用以下说明之一表述其溶解性。DescriptiveTerm说明项PartsofSolventRequiredfor1PartofSolute一份溶质需要的溶剂Verysoluble极易溶解Lessthan1不到1DescriptiveTerm说明项PartsofSolventRequiredfor1PartofSolute一份溶质需要的溶剂Freelysoluble易容From1to101到10Soluble溶解From10to3010到30Sparinglysoluble略溶From30to10030到100Slightlysoluble微溶From100to1,000100到1000Veryslightlysoluble极微溶From1,000to10,0001000到10000Practicallyinsoluble,orInsoluble几乎不容或不溶Greaterthanorequalto10,000大于或等于100005.40.IdentificationTest鉴定测试ThecompendialtesttitledIdentificationisprovidedasanaidinverifyingtheidentityofarticlesastheyarepurportedtobe,e.g.,thosetakenfromlabeledcontainers.TestspresentedintheIdentificationsectionshallbeusedtoassistinestablishingtheidentityofthesubstancebutarenotnecessarilysufficienttoestablishproofofidentity.Othertestsandspecificationsinthemonographoftenarenecessarytoestablishorconfirmtheidentityofanarticle.FailureofanarticletomeettherequirementsofaprescribedIdentificationtestmayindicatethatthearticleismislabeled.药典中的鉴定项是作为鉴定药物（如从贴了标签的容器中取出的药物）的辅助手段。鉴定项的测试用于辅助鉴定原料药，但并不足以鉴定该药品，其鉴定通常还需要专论中其他的测试及质量标准。药品如达不到鉴定测试的要求则可视为贴错标签。5.50.Assay含量Assaytestsforcompoundedpreparationsarenotintendedforevaluatingacompoundedpreparationbeforedispensing,butinsteadareintendedtoserveastheofficialtestintheeventofaquestionordisputeregardingthepreparation'sconformancetoofficialstandards.复方制剂的含量测定不是用于发放前对复方制剂评估，而是当制剂与药典标志一致性有争议时，作为法定的测试。5.50.10.UnitsofPotency(Biological)效价（生物学的）单位Forsubstancesthatcannotbecompletelycharacterizedbychemicalandphysicalmeans,itmaybenecessarytoexpressquantitiesofactivityinbiologicalunitsofpotency,eachdefinedbyanauthoritative,designatedreferencestandard.如果某一物质不能通过化学和物理学方法鉴定，可能需要采用生物效价单位来表示活性成分的含量。每一个单位均由权威的，指定的参考标准来定义。UnitsofbiologicalpotencydefinedbytheWorldHealthOrganization(WHO)forInternationalBiologicalStandardsandInternationalBiologicalReferencePreparationsaretermedInternationalUnits(IU).MonographsrefertotheunitsdefinedbyUSPReferenceStandardsas“USPUnits.”Forbiologicalproducts,unitsofpotencyaredefinedbythecorrespondingU.S.StandardestablishedbyFDA,whetherornotInternationalUnitsorUSPUnitshavebeendefined(seeBiologics<1041>).以WHO规定的国际生物学标准和国际生物学对照品的形式定义的生物效价单位称为国际单位（IU）。专论引用USP对照品标定的单位，即USP单位。对生物制品，无论是否有国际单位或USP单位（见“生物制剂<1041>”），效价均由FDA规定的相应US标准确定。5.60.ImpuritiesandForeignSubstances杂质和外来物质Testsforthepresenceofimpuritiesandforeignsubstancesareprovidedtolimitsuchsubstancestoamountsthatareunobjectionableunderconditionsinwhichthearticleiscustomarilyemployed(seealsoImpuritiesinOfficialArticles<1086>).杂质和外来物质的检测是为了限制这些物质在药品一般条件中可接受的含量（见“药品杂质<1086>”）。Nonmonographtestsandacceptancecriteriasuitablefordetectingandcontrollingimpuritiesthatmayresultfromachangeintheprocessingmethodsorthatmaybeintroducedfromexternalsourcesshouldbeemployedinadditiontothetestsprovidedintheindividualmonograph,wherethepresenceoftheimpurityisinconsistentwithapplicablegoodmanufacturingpracticesorgoodpharmaceuticalpractice.由工艺方法变更或外来物质所引入的杂质，且杂质不符合GMP或制药操作时，可用专论的杂质测试和验收标准进行检测和控制。5.60.10.OtherImpuritiesinUSPandNFArticlesUSP和NF药品的其他杂质IfaUSPorNFmonographincludesanassayororganicimpuritytestbasedonchromatography,otherthanatestforresidualsolvents,andthatmonographproceduredoesnotdetectanimpuritypresentinthesubstance,theamountandidentityoftheimpurity,wherebothareknown,shallbestatedinthelabeling(certificateofanalysis)oftheofficialsubstance,undertheheadingOtherImpurity(ies).除了溶残，如果USP或NF专论中用色谱法做含量或有机杂质检测，而这个方法又检测不到样品中的某一杂质，在这种情况下，如果能鉴别出这个杂质并测出其含量，则必须在标签（分析 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）上列出，同时标明“其他杂质”。Thepresenceofanyunlabeledotherimpurityinanofficialsubstanceisavariancefromthestandardifthecontentis0.1%orgreater.ThesumofallOtherImpuritiescombinedwiththemonograph-detectedimpuritiesmaynotexceed2.0%(seeOrdinaryImpurities<466>),unlessotherwisestatedinthemonograph.其他任何未报告杂质如果大于或等于0.1%，则超出了标准范围。除专论另有规定外，其他专论列出的杂质总杂可能不超过2.0%（见“一般杂质<466>）。ThefollowingcategoriesofdrugsubstancesareexcludedfromOtherImpuritiesrequirements:其他杂质要求不包括以下类型产品：•fermentationproductsandsemi-syntheticsderivedtherefrom,发酵产品和由发酵产品半合成得到的衍生物；•radiopharmaceuticals,发射性药品；•biologics,生物制剂；•biotechnology-derivedproducts,用生物技术得到的衍生物；•peptides,多肽；•herbals,and中草药及•crudeproductsofanimalorplantorigin.动物或植物的提取物AnysubstanceknowntobetoxicshallnotbelistedunderOtherImpurities.其他任何有毒物质必须列出，并标明“其它杂质”。5.60.20.ResidualSolventsinUSPandNFArticlesUSP和NF药品的溶剂残留AllUSPandNFarticlesaresubjecttorelevantcontrolofresidualsolvents,evenwhennotestisspecifiedintheindividualmonograph.Ifsolventsareusedduringproduction,theymustbeofsuitablequality.Inaddition,thetoxicityandresiduallevelofeachsolventshallbetakenintoconsideration,andthesolventslimitedaccordingtotheprinciplesdefinedandtherequirementsspecifiedinResidualSolvent<467>,usingthegeneralmethodspresentedthereinorothersuitablemethods.即使专论中没有特定的检测，所有USP和NF药品都必须控制其溶剂残留。生产中用到溶剂必须符合一定的质量要求。另外，必须考虑每个溶剂的毒性及残留，具体的溶剂限度见“残留溶剂<467>”中的规定和要求，溶剂残留检测可使用这里的一般方法或其他适当的方法。5.70.PerformanceTests性能测试WherecontentuniformitydeterminationshavebeenmadeusingthesameanalyticalmethodologyspecifiedintheAssay,withappropriateallowancesmadefordifferencesinsamplepreparation,theaverageofalloftheindividualcontentuniformitydeterminationsmaybeusedastheAssayvalue.如果含量均匀度使用与含量测定一样的方法，且样品制备方法不同，则含量均匀度的平均值可作为含量使用。5.80.USPReferenceStandardsUSP对照品USPReferenceStandardsareauthenticspecimensthathavebeenapprovedbytheUSPReferenceStandardsExpertCommitteeassuitableforuseascomparisonstandardsinUSPorNFtestsandassays.(SeeUSPReferenceStandards<11>)CurrentofficiallotsofUSPReferenceStandardsarepublishedintheUSPReferenceStandardsCatalog.WhereaprocedurecallsfortheuseofacompendialarticleratherthanforaUSPReferenceStandardasamaterialstandardofreference,asubstancemeetingallofthecompendialmonographrequirementsforthatarticleshallbeused.NonewUSPorNFstandardorprocedurerequiringtheuseofanewUSPReferenceStandardshallbeofficialuntilthespecifiedUSPReferenceStandardisavailable.USP对照品是USP对照品专家委员会批准的用作USP/NF检测或含量测定对照标准的可信的样本（见“USP对照品<11>”）。当前的官方USP对照品批号见USP对照品目录。如果某一检测需要的参照标准物质是官方物质而且不是USP对照品，这个参照物必须符合药典专论的要求。在新USP对照品生效之前，任何新的、需要使用新USP对照品的USP或NF标准、规程都是不合法。Unlessareferencestandardlabelbearsaspecificpotencyorcontent,assumethereferencestandardis100.0%pureintheofficialapplication.Unlessotherwisedirectedintheprocedureintheindividualmonographorinageneralchapter,USPReferenceStandardsaretobeusedinaccordancewiththeinstructionsonthelabeloftheReferenceStandard.除非对照品标签中另有效价或含量的说明，一般对照品都认为是100%纯度。除非专利或附录中另有直接规定，USP对照品一般需按对照品说明使用。6.TESTINGPRACTICESANDPROCEDURES试验规范和过程6.10.SafeLaboratoryPractices安全实验室规范Inperformingcompendialprocedures,safelaboratorypracticesshallbefollowed,includingprecautionarymeasures,protectiveequipment,andworkpracticesconsistentwiththechemicalsandproceduresused.Beforeundertakinganyproceduredescribedinthecompendia,theanalystshouldbeawareofthehazardsassociatedwiththechemicalsandthetechniquesandmeansofprotectingagainstthem.Thesecompendiaarenotdesignedtodescribesuchhazardsorprotectivemeasures.实施药典检测过程，需要遵守安全实验室规范，包括预防性措施，保护设备，与实验物和实验过程一致的 操作规程 操作规程下载怎么下载操作规程眼科护理技术滚筒筛操作规程中医护理技术操作规程 。实验之前，操作人员必需知道相关化合物的危害及对付的技能和方法。药典中不体现这些保护措施。6.20.AutomatedProcedures自动化过程Automatedandmanualproceduresemployingthesamebasicchemistryareconsideredequivalent.基于相同化学技术的自动化及人工操作可认为是等同的。6.30.AlternativeandHarmonizedMethodsandProcedures变通和协调的方法和规程Alternativemethodsand/orproceduresmaybeusediftheyprovideadvantagesintermsofaccuracy,sensitivity,precision,selectivity,oradaptabilitytoautomationorcomputerizeddatareduction,orinotherspecialcircumstances.SuchalternativeproceduresandmethodsshallbevalidatedasdescribedinthegeneralchapterValidationofCompendialProcedures<1225>andmustbeshowntogiveequivalentorbetterresults.Onlythoseresultsobtainedbythemethodsandproceduresgiveninthecompendiumareconclusive.当某个方法或规程有更高的准确性、灵敏度、精确度，或较高的自动化适应性，或能简化计算机数据处理，或在其他特定的环境下，可变通地使用该方法或规程。这些变通的方法和规程必须按照章节“药典规程的验证<1225>”中的方法进行验证，同时必须证明具有同等或更好的实验效果。只有与药典方法和规程相比较的结果才具有权威性。Alternativep