usp凡例

GeneralNoticesandRequirements凡例ApplyingtoStandards,Tests,Assays,andOtherSpecificationsoftheUnitedStatesPharmacopeia应用于美国药典的标准、测试、定量分析、其他质量标准TheGeneralNoticesandRequirements(hereinafterreferredtoastheGeneralNotices)andgeneralrequirementsappearinginGeneralChaptersprovideinsummaryformthebasicguidelinesfortheinterpretationandapplicationofthestandards,tests,assays,andotherspecificationsoftheUnitedStatesPharmacopeiaandeliminatetheneedtorepeatthroughoutthebookthoserequirementsthatarepertinentinnumerousinstances.Wherenospecificlanguageisgiventothecontrary,therequirementsundertheGeneralNoticesandGeneralChaptersapply.凡例（下文中称为凡例）和出现在通则中的常规要求以总结的形式为理解和应用美国药典的标准、测试、定量分析、其他质量标准，提供了基本指导原则，并消除了在全书的无数个案中重复那些要求的必要。在没有具体的言语指向对立情况时，就适用在凡例和通则下的要求。WhereexceptionstotheGeneralNoticesorGeneralChaptersaremade,thewordingintheindividualmonographtakesprecedenceandspecificallyindicatesthedirectionsortheintent.Toemphasizethatsuchexceptionsdoexist,theGeneralNoticesorGeneralChaptersinsomeplacesemploywhereindicatedaqualifyingexpressionsuchas“unlessotherwisespecified.”Intheindividualmonograph,itisunderstoodthatthespecificwordingofstandards,tests,assays,andotherspecificationsisbindingwhereverdeviationsfromtheGeneralNoticesorGeneralChaptersexistwhetherornotastatementofexceptionismade.当不同于凡例和通则的例外发生时，在具体各论中的语句具优先权，并具体地指明了方向或目的。为了强调此类例外确实存在，凡例和通则在某些地方使用了指明适用情况的表达方式，例如“除非另有规定。”在具体的各论中，只要存在与凡例和通则的差异，而不论是否有关于例外的声明，均要认为各论的标准、测试、定量分析、其他质量标准的具体语句必须遵守。TITLE名称Thefulltitleofthispublication,includingitssupplements,isThePharmacopeiaoftheUnitedStatesofAmerica,Thirtiethrevision.ThistitlemaybeabbreviatedtoUnitedStatesPharmacopeia,ThirtiethRevision,ortoUSP30.TheUnitedStatesPharmacopeia,ThirtiethRevision,supersedesallearlierrevisions.Wheretheterm“USP”isused,withoutfurtherqualification,itrefersonlytoUSP30andanysupplement(s)thereto.Thesametitles,withnofurtherdistinction,applyequallytoprintorelectronicpresentationofthesecontents.此出版物包括其增补本的全称为美利坚合众国药典，30版。这个名称可以简称为美国药典30版，或USP30。美国药典30版取代了所有早前的版本。当用到“USP”这个名词时，无需进一步确认，它仅指USP30和对其的任何增补本。同样的名称，没有任何进一步的区别，适用于这些内容的打印或电子版本。“OFFICIAL”AND“OFFICIALARTICLES”“官方的”和“官方物品”Theword“official”,asusedinthisPharmacopeiaorwithreferencehereto,issynonymouswith“Pharmacopeial”,with“USP”,andwith“compendial”.“官方的”一词，在此药典中使用或提到时，是“药典”、“USP”、“药典”的同义词。Thedesignation“USP”inconjunctionwiththeofficialtitleorelsewhereonthelabelofanarticleindicatesthatamonographisincludedintheUSPandthatthearticlepurportstocomplywithallapplicableUSPstandards.Thedesignation“USP”onthelabelmaynotanddoesnotconstitutearepresentation,endorsement,orincorporationbythemanufacture’slabelingoftheinformationalmaterialcontainedintheUSPmonograph,nordoesitconstituteassurancebyUSPthatthearticleisknowntocomplywithaUSPstandardorotherrequirementsonlywhenthearticleisrecognizedintheUSP.Thestandardsapplyequallytoarticlesbearingtheofficialtitlesornamesderivedbytranspositionofthedefinitivewordsofofficialtitlesortranspositionintheorderofthenamesoftwoormoreactiveingredientsinofficialtitles,whetherornottheaddeddesignation“USP”isused.Namesconsideredtobesynonymsoftheofficialtitlesmaynotbeusedforofficialtitles.与药典名称有关或在某个物品标签上的“USP”字样说明在美国药典（USP）中包含了某个各论，并且该物品声称符合所有适用的USP标准。在标签上的“USP”的字样Althoughbothcompendia,theUnitedStatesPharmacopeiaandtheNationalFormulary,currentlyarepublishedunderonecover,theyremainseparatecompendia.ThedesignationUSP-NForsimilarcombinationmaybeusedonthelabelofanarticle,providedthelabelalsobearsastatementsuchas“MeetsNFstandardsaspublishedbytheUSP,”indicatingtheparticularcompendiumtowhichthearticlepurportstoapply.Whereanarticlediffersfromthestandardsofstrength,quality,andpurity,asdeterminedbytheapplicationoftheassaysandtestssetforthforitinthePharmacopeia,itsdifferenceshallbeplainlystatedonitslabel.WhereanarticlefailstocomplyinidentitywiththeidentityprescribedintheUSP,orcontainsanaddedsubstancethatinterfereswiththeprescribedassaysandtests,sucharticleshallbedesignatedbyanamethatisclearlydistinguishinganddifferentiatingfromanynamerecognizedinthePharmacopeia.Articleslistedhereinareofficialandthestandardssetforthinthemonographsapplytothemonlywhenthearticlesareintendedorlabeledforuseasdrugs,asnutritionalordietarysupplements,orasmedicaldevicesandwhenbought,sold,ordispensedforthesepurposesorwhenlabeledasconformingtothisPharmacopeia.AnarticleisdeemedtoberecognizedinthisPharmacopeiawhenamonographforthearticleispublishedinit,includingitssupplements,addenda,orotherinterimrevisions,andanofficialdateisgenerallyorspecificallyassignedtoit.Thefollowingterminologyisusedfordistinguishingthearticlesforwhichmonographsareprovided:anofficialsubstanceisanactivedrugentity,arecognizednutrient,adietarysupplementingredient,orapharmaceuticingredient(seealsoNF26)oracomponentofafinisheddeviceforwhichthemonographtitleincludesnoindicationofthenatureofthefinishedform:anofficialpreparationisadrugproduct,anutritionalsupplement,dietarysupplement,orafinisheddevice.Itisthefinishedorpartiallyfinished(e.g.,asinthecaseofasterilesolidtobeconstitutedintoasolutionforadministration)preparationorproductofoneormoreofficia