药典凡例-美国药典(中英文对照)

本文件由AI本文件由AI进行翻译，仅供行业交流使用，译文准确性不做最终负责，仅供参考GENERALNOTICESANDREQUIREMENTS凡例和要求ApplyingtoStandards,Tests,Assays,andOtherSpecificationsoftheUnitedStatesPharmacopeia适用于《美国药典》的标准、测试、化验和其他规范TheGeneralNoticesandRequirementssection(theGeneralNotices)presentsthebasicassumptions,definitions,anddefaultconditionsfortheinterpretationandapplicationoftheUnitedStatesPharmacopeia(USP)andtheNationalFormulary(NF).(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.USPNF（《药典》）认可的所有全部专论和全部通则。TITLEANDREVISION标题和版本ThefulltitleofthisjointcompendiumisThePharmacopeiaoftheUnitedStatesofAmericaandtheNationalFormulary(USP–NF).AlthoughUSPandNFarepublishedtogetherandsharetheseGeneralNotices,theyareseparatecompendia.Wheretheterms“USP”,“NF”,or“USP–NF”areusedwithoutfurtherqualification,theyrefertothecurrentlyofficialstandard.USP–NF全称是《美利坚合众国药典》和《国家处方集》。尽管USP和NF一起出版并共享这些凡例，"USP"、"NF"USP-NF等术语而未作进一步限定时，均指当前的法定标准。NewandrevisedcontentisaddedtotheUSP–NFperiodically(seesection2.10OfficialText).Routinerevisionsarepublishedthreetimesayear,onthefollowingdates,correspondingwiththree“issues”:USP-NF定期添加新内容和修订内容（2.10节正式文本）。常规修订每年出版三次，日期如下，对应"issues"：USP–NF2021Issue1:PublishedNovember1,USP-NF20211期：111日出版、2020USP–NF2021Issue2:PublishedFebruary1,2020USP-NF20212期：2月1日出版、2021USP–NF2021Issue3:PublishedJune1,20212021USP-NF20213期：20216月1日出版“Issues”representdatesonwhichnewandrevisedcontentisaddedtotheUSP–NF.TheUSP–NFisincontinuousrevision,withstandardshavingofficialdatesthatcorrespondtotheirspecificrevisionhistories."Issues"代表USP-NF添加新内容和修订内容的日期。USP-NF不断修订，标准的正式日期与其具体的修订历史相对应。Changetoread:改为OFFICIAL STATUS AND RECOGNITION官方地位和法律承认2.10OfficialText正式文本OfficialtextoftheUSPandNFispublishedonlineathttps://.USPNF的正式文本在https://上在线发布。RoutinerevisionsarepublishedintheUSP–NFandbecomeofficialonthedateindicated,usuallysixmonthsafterpublication.USP-NF中公布，并在所示日期（通常是公布后六个月）成为正式版本。AcceleratedRevisions,publishedperiodicallyintheUSP–NF,aredesignedtomakerevisionsofficialmorequicklythanthroughtheroutineprocessforpublishingstandardsintheUSP–NF.AcceleratedRevisionsmayalsobepublishedontheOfficialTextsectionofUSP’swebsite(ww/official-text).AcceleratedRevisionssupersedepreviouslypublishedcontentandbecomeofficialonthedateindicated.USP-NFUSP-NF中出版标准的常规程序更快的速度使修订成为正USP(ww/official-text)的正式文本部分发布。加速修订版取代之前发布的内容，并在所示日期成为正式版本。InterimRevisionAnnouncementsareAcceleratedRevisionstoUSPandNFthatcontainrevisionsandtheirofficialdates.USPNF的加速修订版，其中包含修订内容及其正式日期。RevisionBulletinsareAcceleratedRevisionstoofficialtextorpostponementsthatrequireexpeditedpublication.TheygenerallyareofficialimmediatelyunlessotherwisespecifiedintheRevisionBulletin.修订公告是对正式文本的加速修订或需要快速发布的延期公告。除非修订公告中另有说明，否则它们通常立即成为正式文本。ErrataareAcceleratedRevisionsrepresentingcorrectionstoitemserroneouslypublished.勘误表是加速修订本，是对错误出版的项目所作的更正。Periodically,anon-officialvolumeofassociatedrevisionsandadditionstotheUSP–NFispublishedinprintorothermedia.Thisvolumeisintendedtoserveasahistoricalreferencedocumentandisnotconsideredofficialtext.USP-NF的相关修订和增补内容会定期以印刷品或其他媒体形式出版非官方版本。本卷旨在作为历史参考文件，不被视为正式文本。2.20OfficialArticles法定产品AnofficialarticleisanarticlethatisrecognizedinUSPorNF.Anarticleisdeemedtoberecognizedandincludedinacompendiumwhenamonographforthearticleispublishedinthecompendiumandanofficialdateisgenerallyorspecificallyassignedtothemonograph.法定产品是USP或NF认可的产品。当某一产品的专论在药典中出版，且该专论一般或特别指定了正式日期时，该产品即被视为得到认可并被纳入药典。Thetitlespecifiedinamonographistheofficialtitleforsucharticle.Othernamesconsideredtobesynonymsoftheofficialtitlesmaynotbeusedassubstitutesforofficialtitles.▲ForabiologicproductlicensedunderthePublicHealthServiceAct,theofficialtitleshallbethetitlespecifiedintherelevantmonographplusanyprefixand/orsuffixdesignatedbytheFDAunlessotherwisespecifiedintheapplicablemonograph.▲(USP1-Dec-2022)Fordrugproductsthatincorporateasensortodetectthattheproducthasbeenadministered,theofficialtitleshallbethetitlespecifiedintherelevantdrugproductmonographplusthewords“withsensor”.专论中指定的标题是该文章的正式标题。不得使用被视为正式名称同义词的其他名称替代正式名称。对于根据公共卫生服务法获得许可的生物制品，正式名称应为相关专论中规定的名称加上FDA指定的任何前缀和/或后缀，除非适用专论中另有规定。(USP1-Dec-2022)对于装有传感器以检测产品是否已给药的药品，正式名称应为相关药品专论中规定的名称加上""字样。Officialarticlesincludebothofficialsubstancesandofficialproducts.Anofficialsubstanceisadrugsubstance,excipient,dietaryingredient,otheringredient,orcomponentofafinisheddeviceforwhichthemonographtitleincludesnoindicationofthenatureofthefinishedform.法定产品包括法定物质和法定产品。法定物质是一种原料药、辅料、膳食成分、其他成分或成品器械的组成部分，其专论标题不包括成品形式性质的说明。2.30LegalRecognition法律认可TheUSPandNFarerecognizedinthelawsandregulationsofmanycountriesthroughouttheworld.RegulatoryauthoritiesmayenforcethestandardspresentedintheUSPandNF,butbecauserecognitionoftheUSPandNFmayvarybycountry,usersshouldunderstandapplicablelawsandregulations.IntheUnitedStatesundertheFederalFood,Drug,andCosmeticAct(FDCA),bothUSPandNFarerecognizedasofficialcompendia.AdrugwithanamerecognizedinUSP–NFmustcomplywithcompendialidentitystandardsorbedeemedadulterated,misbranded,orboth.See,e.g.,FDCA§501(b)and502(e)(3)(b);alsoU.S.FoodandDrugAdministration(FDA)regulations,21CFR§299.5(a&b).Toavoidbeingdeemedadulterated,suchdrugsmustalsocomplywithcompendialstandardsforstrength,quality,andpurity,unlesslabeledtoshowallrespectsinwhichthedrugdiffers.See,e.g.,FDCA§501(b)and21CFR§299.5(c).Inaddition,toavoidbeingdeemedmisbranded,drugsrecognizedinUSP–NFmustalsobepackagedandlabeledincompliancewithcompendialstandards.SeeFDCA§502(g).USPNFUSPNF中提出的标准，但由于各国对USP和NF的认可程度可能不同，用户应了解适用的法律和法规。在美国，根据联邦食品(FDCA)，USPNF都被认定为官方药典。USP-NF认可的药品名称必须符合药典身FDCA§501(b)502(e)(3)(b)；另见美(FDA)法规，21CFR§299.5(a&b)。为避免被视为掺假，此类药品还必须符合药典规FDCA§501(b)21CFR§299.5(c)502(g)。AdietarysupplementrepresentedasconformingtospecificationsinUSPwillbedeemedamisbrandedfoodifitfailstosoconform.SeeFDCA§403(s)(2)(D).FDCA§403(s)(2)(D)。EnforcementofUSPstandardsistheresponsibilityofFDAandothergovernmentauthoritiesintheU.S.andelsewhere.USPhasnoroleinenforcement.USPFDA和其他政府机构负责。USP不参与执行工作。CONFORMANCETOSTANDARDS符合标准3.10ApplicabilityofStandards标准的适用性Standardsforanarticlerecognizedinthecompendia(USP–NF)areexpressedinthearticle’smonograph,applicablegeneralchapters,andGeneralNotices.Theidentity,strength,quality,andpurityofanarticlearedeterminedbytheofficialtests,procedures,andacceptancecriteria,andotherrequirementsincorporatedinthemonograph,inapplicablegeneralchapters,orintheGeneralNotices.药典(USP-NF)认可的产品标准在产品的专论、适用的通则和凡例中表述。产品的特性、强度、质量和纯度由官方测试、程序和可接受标准以及专论、不适用的通则章节或一般公告中包含的其他要求决定。Inamonograph,requirementsforofficialarticlesareindicatedintwoways:(1)forcertainmonographs,aftertheofficialtitle,theprimarilyinformationalportionsofthetextappearfirst,followedbythetextcomprisingrequirements,thelattersectionofthemonographbeingintroducedbyadoublearrowsymbol»;and(2)formonographsmorerecentlyredesigned,requirementsappearintheofficialtitleandinanytextbeginningwiththesectiontitled“Definition”.Ineitherformat,informationthatappears:(1)afterthetitlebutbeforethedoublearrowsymbol;(2)afterthetitlebutbeforethesectiontitled“Definition”;or(3)inorafterthesectiontitled“AuxiliaryInformation”isprovidedforinformationalpurposes.SeePrefaceforinformationrelatedtoupdatestoChemicalInformation.)的主要信息部分，然后是包含要求的正文，专论的后一部分用双箭头符号»表示；(2)对于最近重新设计位置的信息仅供参考：(1)标题之后，双箭头符号之前；(2)标题之后，"定义"部分之前；或(3)"辅助信"部分中或之后。有关""更新的信息，请参见"前言"。WhereconformancetoanyspecificationsrepresentedbyChemicalInformationiscriticaltoestablishingidentity,purity,potency,oranotherqualityattributeofanofficialarticle,themonographwillincludesuchspecificationsinthetextthatstatesrequirements.论将在说明要求的文本中包括这些规格。“Applicablegeneralchapters”meansgeneralchaptersnumberedbelow1000orabove2000thataremadeapplicabletoanarticlethroughreferenceinGeneralNotices,amonograph,oranotherapplicablegeneralchapternumberedbelow1000.WheretherequirementsofamonographdifferfromtherequirementsspecifiedintheseGeneralNoticesoranapplicablegeneralchapter,themonographrequirementsapplyandsupersedetherequirementsoftheGeneralNoticesorapplicablegeneralchapters,whetherornotthemonographexplicitlystatesthedifference."适用的通则"是指编号低于1000或高于2000的通则，这些章节通过凡例、专论或编号低于1000的另一适用的通则的提及而适用于某一产品。如果专论的要求与凡例或通则中规定的要求不同时，则专论的要求适用并取代凡例或通则的要求，无论专论是否明确说明了两者的区别。Generalchaptersnumbered1000to1999areforinformationalpurposesonly.Theycontainnomandatorytests,assays,orotherrequirementsapplicabletoanyofficialarticle,regardlessofcitationinageneralchapternumberedbelow1000,amonograph,ortheseGeneralNotices.Generalchaptersnumberedabove2000applyonlytoarticlesthatareintendedforuseasdietaryingredientsanddietarysupplements.GeneralchaptercitationsinNFmonographsrefertoUSPgeneralchapters.编号为1000至1999的总章仅供参考。它们不包含适用于任何法定产品的强制性试验、化验或其他要求，无论编号低于1000的总章、专论或凡例中如何引用。编号高于2000的总章仅适用于用作膳食成分和膳食补充剂的产品。NFUSP通则。EarlyadoptionofrevisedstandardsinadvanceoftheofficialdateisallowedbyUSPunlessspecifiedotherwiseatthetimeofpublication.Whererevisedstandardsforanexistingarticlehavebeenpublishedasfinalapproved“officialtext”(asapprovedinsection2.10OfficialText)buthavenotyetreachedtheofficialdate(6monthsafterpublication,unlessotherwisespecified;see“officialdate”,section2.20OfficialArticles),compliancewiththerevisedstandardshallnotprecludeafindingorindicationofconformancewithcompendialstandards,unlessUSPspecifiesotherwisebyprohibitingearlyadoptioninaparticularstandard.USP允许在正式日期之前提前采用修订标准，除非在出版时另有规定。如果现有产品的修订标准已作为最"正式文本"（2.10""中批准）出版，但尚未达到正式日期（6个月，除2.20"""法定产品"），USP另有规定，禁止在特定标准中提前采用，否则遵守修订标准并不妨碍发现或表明符合药典标准。Thestandardsintherelevantmonograph,generalchapter(s),andGeneralNoticesapplyatalltimesinthelifeofthearticlefromproductiontoexpiration.Itisalsonotedthatthemanufacturer’sspecifications,andmanufacturingpractices(e.g.,QualitybyDesign,ProcessAnalyticalTechnology,andRealTimeReleaseTestinginitiatives),generallyarefollowedtoensurethatthearticlewillcomplywithcompendialstandardsuntilitsexpirationdate,whenstoredasdirected.Everycompendialarticleincommerceshallbesoconstitutedthatwhenexaminedinaccordancewiththeseassaysandtestprocedures,itmeetsallapplicablepharmacopeialrequirements(GeneralNotices,monographs,andgeneralchapters).Thus,anyofficialarticleisexpectedtomeetthecompendialstandardsiftested,andanyofficialarticleactuallytestedasdirectedintherelevantmonographmustmeetsuchstandardstodemonstratecompliance.相关专论、通则和凡例中的标准适用于产品从生产到失效的整个生命周期。还应注意的是，制造商的规范和生产实践（如设计质量、工艺分析技术和实时释放测试计划）一般都会得到遵守，以确保产品在按规定储存时，在有效期前都符合药典标准。商业中的每种药典产品在按照这些检测方法和测试程序进行检查时，都应符合所有适用的药典要求（总则、专论和通则）。因此，任何法定产品经检测后都应符合药典标准，而任何法定产品按相关专论的指示进行实际检测后都必须符合这些标准，以证明其符合要求。Sometests,suchasthoseforDissolutionandUniformityofDosageUnits,requiremultipledosageunitsinconjunctionwithadecisionscheme.Thesetests,albeitusinganumberofdosageunits,areinfactonedetermination.Theseproceduresshouldnotbeconfusedwithstatisticalsamplingplans.Thesimilaritytostatisticalproceduresmayseemtosuggestanintenttomakeinferencetosomelargergroupofunits,butinallcases,statementsaboutwhetherthecompendialstandardismetapplyonlytotheunitstested.Repeats,replicates,statisticalrejectionofoutliers,orextrapolationsofresultstolargerpopulations,aswellasthenecessityandappropriatefrequencyofbatchtesting,areneitherspecifiednorproscribedbythecompendia;suchdecisionsarebasedontheobjectivesofthetesting.Frequencyoftestingandsamplingarelefttothepreferencesordirectionofthoseperformingcompliancetesting,andotherusersofUSP–NF,includingmanufacturers,buyers,orregulatoryauthorities.有些检验，如溶解度检验和剂量单位均匀性检验，需要多个剂量单位和一个判定方案。这些检验虽然使用了多个剂量单位，但实际上是一种测定方法。这些程序不应与统计抽样计划相混淆。与统计程序的相似性似乎暗示着要对更大的一组单位进行推断，但在任何情况下，关于是否符合药典标准的声明都只适用于所测试的单位。重复、再现、对异常值的统计剔除、或将结果推断到更大的群体，以及批量测试的必要性和适当频率，既没有在药典中明确规定，也没有在药典中加以禁止；这些决定都是根据测试的目标作出的。USP-NF的其他用户（包括制造商、买家或监管机构）自行决定。OfficialproductsarepreparedaccordingtorecognizedprinciplesofgoodmanufacturingpracticeandfromingredientsthatmeetUSPorNFstandards,wherestandardsforsuchingredientsexist(fordietarysupplements,seesection3.10.20ApplicabilityofStandardstoMedicalDevices,DietarySupplements,andTheirComponentsandIngredients).法定产品是根据公认的良好生产规范原则制备的，其成分符合USP或NF标准（如果有此类成分的标准）（3.10.20"标准对医疗器械、膳食补充剂及其成分和配料的适用性"）。Officialsubstancesarepreparedaccordingtorecognizedprinciplesofgoodmanufacturingpracticeandfromingredientscomplyingwithspecificationsdesignedtoensurethattheresultantsubstancesmeettherequirementsofthecompendialmonographs.法定产品是根据公认的良好生产规范原则，用符合规范的成分制备的，目的是确保制得的物质符合药典专论的要求。3.10.10.ApplicabilityofStandardstoDrugProducts,DrugSubstances,and3.10.10.ApplicabilityofStandardstoDrugProducts,DrugSubstances,andExcipients标准对药品、原料药和辅料的适用性TheapplicableUSPorNFstandardappliestoanyarticlemarketedintheUnitedStatesthat(1)isrecognizedinthecompendiumand(2)isintendedorlabeledforuseasadrugorasaningredientinadrug.Sucharticles(drugproducts,drugsubstances,andexcipients)includebothhumandrugs(whetherdispensedbyprescription,“overthecounter”,orotherwise),aswellasanimaldrugs.Theapplicablestandardappliestosucharticleswhetherornottheaddeddesignation“USP”or“NF”isused.Thestandardsapplyequallytoarticlesbearingtheofficialtitlesornamesderivedbytranspositionofthedefinitivewordsofofficialtitlesortranspositionintheorderofthenamesoftwoormoredrugsubstancesinofficialtitles,orwherethereisuseofsynonymswiththeintentoreffectofsuggestingasignificantdegreeofidentitywiththeofficialtitleorname.适用的USP或NF标准适用于在美国市场上销售的任何产品，这些产品(1)得到药典认可，(2)打算或标明用作药物或药物成分。此类产品（药品、原料药和辅料）既包括人类药物（无论是处方药、"非处方药"还是其他药物），也包括动物药物。无论是否添加了"USP"或"NF"名称，适用标准都适用于此类产品。这些标准同样适用于带有正式名称或通过调换正式名称中的定语或调换正式名称中两种或两种以上原料药名称的顺序而产生的名称的产品，或使用同义词的意图或效果是暗示与正式名称或名称有很大程度的相同之处的产品。3.10.20.ApplicabilityofStandardstoMedicalDevices,DietarySupplements,and3.10.20.ApplicabilityofStandardstoMedicalDevices,DietarySupplements,andTheirComponentsandIngredients.标准对医疗器械、膳食补充剂及其成分和配料的适用性AnarticlerecognizedinUSPorNFshallcomplywiththecompendialstandardsifthearticleisamedicaldevice,componentintendedforamedicaldevice,dietarysupplement,dietaryingredient,orotheringredientthatisintendedforincorporationintoadietarysupplement,andislabeledasconformingtotheUSPorNF.USPNF认可的产品应符合药典标准，前提是该产品是医疗器械、医疗器械部件、膳食补充剂、膳食成分或其他旨在加入膳食补充剂的成分，并标明符合USPNF标准。Generally,dietarysupplementsarepreparedfromingredientsthatmeetUSP,NF,orFoodChemicalsCodexstandards.Wheresuchstandardsdonotexist,substancesmaybeusedindietarysupplementsiftheyhavebeenshowntobeofacceptablefoodgradequalityusingothersuitableprocedures.一般来说，膳食补充剂是用符合USP、NF或食品化学法典标准的成分制成的。在没有此类标准的情况下，如果使用其他合适的程序证明这些物质具有可接受的食品级质量，则可将其用于膳食补充剂。本文件由AI本文件由AI进行翻译，仅供行业交流使用，译文准确性不做最终负责，仅供参考3.10.303.10.30ApplicabilityofStandardstothePracticeofCompounding标准对复方制剂生产的适用性USPcompoundingpracticestandards,PharmaceuticalCompounding—NonsterilePreparations795andPharmaceuticalCompounding—SterilePreparations〈797,asappropriate,applytocompoundingpracticeoractivityregardlessofwhetheramonographexistsforthecompoundedpreparationorthesechaptersarereferencedinsuchamonographIntheUnitedStates,〈795〉and〈797〉arenotapplicabletodrugscompoundedbyentitiesregisteredwithFDAasoutsourcingfacilitiesasdefinedbyFDCA§503B,becausesuchfacilitiesarerequiredtocomplywithFDA’scurrentgoodmanufacturingpracticerequirements.美国药典复方制剂实践标准药物复方制剂-非无菌制剂〈795〉和药物复方制剂-无菌制剂〈797〉酌情适用于复方制剂实践或活动，而不论复方制剂是否存在专论，也不论此类专论是否引用了这些章节。在美国，〈795〉和〈797〉不适用于在FDA注册为FDCA第503B节定义的外包设施的实体所配制的药物，因为这类设施必须遵守FDA现行的良好生产规范要求。Compoundedpreparations,includingdrugproductscompoundedbyoutsourcingfacilities,mayalsobesubjecttoapplicablemonographs;seesection2.20OfficialArticlesandsection4.10Monographs.2.20""4.10"专论"。3.10.403.10.40ApplicabilityofGlobalHealthMonographs全球卫生专论的适用性GlobalHealthMonographs(GHM)donotapplytoproductsmarketedintheUnitedStates.MonographsinthissectionoftheUSP–NFarenotconsidered“applicable”USP–NFmonographsforuseinpharmacycompoundingintheUnitedStatesundertheFederalFood,Drug,andCosmeticAct.GHMsareprovidedforpossibleuseoutsideoftheUnitedStates,atthediscretionofindividualgovernmentauthorities.全球保健专论(GHM)不适用于在美国销售的产品。根据《联邦食品、药品和化妆品法》，USP-NF本节""USP-NF专论。GHM供美国境外使用，由各政府部门自行决定。ApplicabilityofaGHM,inwholeorinpart,alongwiththeapplicabilityofassociatedGeneralNoticesandgeneralchapterrequirements,inwholeorinpart,isatthediscretionofindividualgovernmentauthorities.全球健康手册的全部或部分适用性，以及相关的凡例和通则要求的全部或部分适用性，由各政府当局自行决定。WhereaproductpurportstocomplywiththerequirementsofanofficialGHM,itisrecommendedthattheproductlabelorlabelingclearlyspecifyconformancetoaGHM,e.g.,“USP-GHM”or“USP–GH”.Thedesignations,“USP–NF”,“USP”,and“NF”shouldbeusedonlytoindicateconformancetoUSPorNFmonographsoutsideofGHMs(seesection3.20IndicatingConformance).如果产品声称符合官方GHM的要求，建议在产品标签上明确注明符合GHM"USP-GHM"或"USP-GH"USP-NF""USP"NFGHMUSPNF（见第3.20"表示符合性"）。Thedesignation“USP–GHM”or“USP–GH”onthelabel"USP-GHM"USP-GHmaynotanddoesnotconstituteanendorsementbyUSPanddoesnotrepresentassurancebyUSPthatthearticleisknowntocomplywiththerelevantstandards.USPmayseeklegalredressifanarticlepurportstobeorisrepresentedasanofficialGHMarticleandsuchclaimisdeterminedbyUSPnottobemadeingoodfaith.USP可能也不会认可该产品，也不代表USP保证该产品符合相关标准。如果某产品声称是或被表示为官方GHM产品，而USP认定该声称并非出于善意，USP可能会寻求法律补救。EnforcementofGHMrequirementsistheresponsibilityofgovernmentauthoritiesoutsideoftheU.S.USPhasnoroleinenforcement.GHM要求的执行由美国以外的政府部门负责，USP不参与执行。3.20IndicatingConformance显示一致性Adrugproduct,drugsubstance,orexcipientmayusethedesignation“USP”or“NF”inconjunctionwithitsofficialtitleorelsewhereonthelabelonlywhen(1)amonographisprovidedinthespecifiedcompendiumand(2)thearticlecomplieswiththeidentityprescribedinthespecifiedcompendium.(1)特定药典提供了专论，且(2)产品符合特定药典规定的特征时，才可在其正式名称或标签的其他地方使用"USP"或"NF"名称。Whenadrugproduct,drugsubstance,compoundedpreparation,orexcipientdiffersfromtherelevantUSPorNFstandardofstrength,quality,orpurity,asdeterminedbytheapplicationofthetests,procedures,andacceptancecriteriasetforthintherelevantcompendium,itsdifferenceshallbeplainlystatedonitslabel.当药品、原料药、复方制剂或辅料在强度、质量或纯度方面不同于相关USP或NF标准（根据相关药典规定的测试、程序和可接受标准确定）时，应在其标签上明确说明其差异。Whenadrugproduct,drugsubstance,compoundedpreparation,orexcipientfailstocomplywiththeidentityprescribedinUSPorNForcontainsanaddedsubstancethatinterfereswiththeprescribedtestsandprocedures,thearticleshallbedesignatedbyanamethatisclearlydistinguishinganddifferentiatingfromanynamerecognizedinUSPorNF.当药品、原料药、复方制剂或赋形剂不符合USP或NF规定的特性，或含有干扰规定的测试和程序的添加物质时，产品的名称应明显区别于USPNF中认可的任何名称。Amedicaldevice,dietarysupplement,oringredientorcomponentofamedicaldeviceordietarysupplementmayusethedesignation“USP”or“NF”inconjunctionwithitsofficialtitleorelsewhereonthelabelonlywhen(1)amonographisprovidedinthespecifiedcompendiumand(2)thearticlecomplieswiththemonographstandardsandotherapplicablestandardsinthatcompendium.医疗器械、膳食补充剂或医疗器械或膳食补充剂的成分或组分只有在以下情况下才可在其正式名称或标签"USP"NF名称：(1)特定药典中提供了专论；(2)产品符合该药典中的专论标准和其他适用标准。Thedesignation“USP–NF”maybeusedonthelabelofanarticleprovidedthatthelabelalsobearsastatementsuchas“MeetsNFstandardsaspublishedbyUSP”,indicatingtheparticularcompendiumtowhichthearticlepurportstoapply.USP-NF"名称可用于产品标签上，条件是标签上还必须注明"符合USP公布的NF标准"等字样，并注明产品声称适用的特定药典。Whentheletters“USP”,“NF”,or“USP–NF”areusedonthelabelofanarticletoindicatecompliancewithcompendialstandards,thelettersshallappearinconjunctionwiththeofficialtitleofthearticle.Thelettersarenottobeenclosedinanysymbolsuchasacircle,square,etc.,andshallappearincapitalletters."USP"、"NF"USP-NF表示符合药典标准时，字母应与产品的正式名称一起出现。字母不得与任何符号（如圆形、方形等）结合，并应以大写字母显示。IfadietarysupplementdoesnotcomplywithallapplicablecompendialrequirementsbutcontainsoneormoredietaryingredientsorotheringredientsthatarerecognizedinUSPorNF,theindividualingredient(s)maybedesignatedascomplyingwithUSPorNFstandardsorbeingofUSPorNFqualityprovidedthatthedesignationislimitedtotheindividualingredient(s)anddoesnotsuggestthatthedietarysupplementcomplieswithUSPstandards.如果膳食补充剂不符合所有适用的药典要求，但含有一种或多种膳食成分或USP或NF认可的其他成分，则可将个别成分指定为符合USP或NF标准或具有USP或NF质量，但指定仅限于个别成分，并不USP标准。MONOGRAPHSANDGENERALCHAPTERS专论和通则4.10Monographs专论Monographssetforththearticle’sname,definition,specification,andotherrequirementsrelatedtopackaging,storage,andlabeling.Thespecificationconsistsoftests,procedures,andacceptancecriteriathathelpensuretheidentity,strength,quality,andpurityofthearticle.Forgeneralrequirementsrelatingtospecificmonographsections,seesection5.MonographComponents.Becausemonographsmaynotprovidestandardsforallrelevantcharacteristics,someofficialsubstancesmayconformtotheUSPorNFstandardbutdifferwithregardtononstandardizedpropertiesthatarerelevanttotheiruseinspecificpreparations.Toassuresubstitutabilityinsuchinstances,usersmaywishtoascertainfunctionalequivalenceordeterminesuchcharacteristicsbeforeuse.专论规定了产品的名称、定义、规格以及与包装、储存和标签有关的其他要求。规范包括有助于确保产品5节。专论组成部分。由于专论可能无法提供所有相关特性的标准，因此某些法定产品可能符合USP或NF标准，但在与特定制剂用途相关的非标准化特性方面存在差异。在这种情况下，为确保可替代性，用户可能希望在使用前确定功能等同性或确定此类特性。0.10ApplicabilityofTestProcedures分析过程的适用性Asinglemonographmayincludemorethanonetest,procedure,and/oracceptancecriterionforthesameattribute.Unlessotherwisespecifiedinthemonograph,alltestsarerequirements.Insomecases,monographinstructionsallowtheselectionofteststhatreflectattributesofdifferentmanufacturers’articles,suchasdifferentpolymorphicforms,impurities,hydrates,anddissolution.Monographinstructionsindicatethetests,procedures,and/oracceptancecriteriatobeusedandtherequiredlabeling.一个专论可能包含多个针对同一属性的检验、程序和/或可接受标准。除非专论中另有规定，否则所有检验都是要求。在某些情况下，专论说明书允许选择反映不同制造商产品属性的试验，如不同的多晶型、杂质、水合物和溶解度。专论说明书说明所用的试验、程序和/或可接受标准以及所要求的标签。TheorderinwhichthetestsarelistedinthemonographisbasedontheorderinwhichtheyareapprovedbytherelevantExpertCommitteeforinclusioninthemonograph.Test1isnotnecessarilythetestfortheinnovatororforthereferenceproduct.Dependingonmonographinstructions,alabelingstatementisnottypicallyrequiredifTest1isused.1不一定是创新产品或参比产品的试验。根据专论的说明，如果使用试验1，一般不需要标签说明。0.20AcceptanceCriteria可接受标准Theacceptancecriteriaallowforanalyticalerror,forunavoidablevariationsinmanufacturingandcompounding,andfordeteriorationtoanextentconsideredacceptableunderpracticalconditions.Theexistenceofcompendialacceptancecriteriadoesnotconstituteabasisforaclaimthatanofficialsubstancethatmorenearlyapproaches100%purity“exceeds”compendialquality.Similarly,thefactthatanarticlehasbeenpreparedtotightercriteriathanthosespecifiedinthemonographdoesnotconstituteabasisforaclaimthatthearticle“exceeds”thecompendialrequirements.可接受标准允许存在分析误差、制造和配制过程中不可避免的差异，以及在实际条件下可接受的变质程度100%""药典质量的依据。同样，按照比专论规定更严格的标准制备产品的事实，也不构成声称该产品"超过"药典要求的依据。Anofficialproductshallbeformulatedwiththeintenttoprovide100%ofthequantityofeachingredientdeclaredonthelabel.Wheretheminimumamountofasubstancepresentinadietarysupplementisrequiredbylawtobehigherthantheloweracceptancecriterionallowedforinthemonograph,theupperacceptancecriterioncontainedinthemonographmaybeincreasedbyacorrespondingamount.法定产品必须100%提供标签上标明的每种成分的含量。如果法律要求膳食补充剂中某种物质的最低含量高于专论中允许的较低接受标准，则专论中的较高接受标准可相应增加。Theacceptancecriteriaspecifiedinindividualmonographsandinthegeneralchaptersforcompoundedpreparationsarebasedonsuchattributesofqualityasmightbeexpectedtocharacterizeanarticlecompoundedfromsuitablebulkdrugsubstancesandingredients,usingtheproceduresprovidedorrecognizedprinciplesofgoodcompoundingpractice,asdescribedinthesecompendia.专论和总论中规定的复方制剂可接受标准，是根据这些药典中规定的程序或公认的良好复方制剂操作原则，从合适的原药和配料中复方制得的产品的预期质量特性制定的。4.20GeneralChapters通则Eachgeneralchapterisassignedanumberthatappearsinanglebracketsadjacenttothechaptername(e.g.,Chromatography〈621〉Generalchaptersmaycontainthefollowing:每个通则都有一个编号，编号出现在章节名称旁边的角括号中（例如，《色谱法〈621〉》）。通则可包含以下内容：Descriptionsoftestsandproceduresforapplicationthroughindividualmonographs,通过专论对应用的测试和程序进行说明、Descriptionsandspecificationsofconditionsandpracticesforpharmaceuticalcompounding,药品配制条件和规范的说明和规格、Generalinformationfortheinterpretationofthecompendialrequirements,解释药典要求的一般信息，Descriptionsofgeneralpharmaceuticalstorage,dispensing,andpackagingpractices,or一般药品储存、配发和包装规范的说明，或Generalguidancetomanufacturersofofficialsubstancesorofficialproducts.对官方物质或官方产品制造商的一般指导。Whenageneralchapterisreferencedinamonograph,acceptancecriteriamaybepresentedafteracolon.在专论中引用通则时，可在冒号后列出可接受标准。Somechaptersmayserveasintroductoryoverviewsofatestorofanalyticaltechniques.Theymayreferenceothergeneralchaptersthatcontaintechniques,detailsoftheprocedures,and,attimes,acceptancecriteria.有些章节可作为测试或分析技术的介绍性概述。这些章节可能会参考其他包含技术、程序细节以及可接受标准的通则。MONOGRAPHCOMPONENTS专论的组成部分5.10MolecularFormula分子式Theuseofthemolecularformulafortheofficialsubstance(s)namedindefiningtherequiredstrengthofacompendialarticleisintendedto