1GENERALNOTICES凡例1.1GENERALSTATEMENTS概述TheGeneralNoticesapplytoallmonographsandothertextsoftheEuropeanPharmacopoeia.凡例的内容适用于各论和欧洲药典中的其它章节。TheofficialtextsoftheEuropeanPharmacopoeiaarepublishedinEnglishandFrench.TranslationsinotherlanguagesmaybepreparedbythesignatoryStatesoftheEuropeanPharmacopoeiaConvention.Incaseofdoubtordispute,theEnglishandFrenchversionsarealoneauthoritative.欧洲药典以英语和法语形式发行，欧洲药典委员会的签署国可将药典内容译成其它语言，但若发生争议，应以英语和法语版为权威。InthetextsoftheEuropeanPharmacopoeia,theword‘Pharmacopoeia’withoutqualificationmeanstheEuropeanPharmacopoeia.TheofficialabbreviationPh.Eur.maybeusedtoindicatetheEuropeanPharmacopoeia.在欧洲药典中，如无特殊规定，“药典”是指欧洲药典，官方缩写Ph.Eur.也指欧洲药典。Theuseofthetitleorthesubtitleofamonographimpliesthatthearticlecomplieswiththerequirementsoftherelevantmonograph.SuchreferencestomonographsinthetextsofthePharmacopoeiaareshownusingthemonographtitleandreferencenumberinitalics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。文章参考药典中各论内容时，以斜体的各论题目或相关数字表示。Apreparationmustcomplythroughoutitsperiodofvalidity;adistinctperiodofvalidityand/orspecificationsforopenedorbroachedcontainersmaybedecidedbythecompetentauthority.Thesubjectofanyothermonographmustcomplythroughoutitsperiodofuse.Theperiodofvaliditythatisassignedtoanygivenarticleandthetimefromwhichthatperiodistobecalculatedaredecidedbythecompetentauthorityinlightofexperimentalresultsofstabilitystudies.制剂在有效期内必须性质稳定，明确的有效期或说明书应由权力机构批准。任何各论的物质也必须服从其使用期限。任何药品的有效期和有效期的计算由权力机构经稳定性研究的试验结果决定。UnlessotherwiseindicatedintheGeneralNoticesorinthemonographs,statementsinmonographsconstitutemandatoryrequirements.Generalchaptersbecomemandatorywhenreferredtoinamonograph,unlesssuch1referenceismadeinawaythatindicatesthatitisnottheintentiontomakethetextreferredtomandatorybutrathertociteitforinformation.Theactivesubstances,excipients,pharmaceuticalpreparationsandotherarticlesdescribedinthemonographsareintendedforhumanandveterinaryuse(unlessexplicitlyrestrictedtooneoftheseuses).AnarticleisnotofPharmacop