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，质量标准，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昀小量，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。Theacceptancecriteriaspecifiedinindividualmonographsandinthegeneralchaptersforcompoundedpreparationsarebasedonsuchattributesofqualityasmightbeexpectedtocharacterizeanarticlecompoundedfromsuitablebulkdrugsubstancesandingr