包装和储存条件

丽珠集团福州福兴医药有限公司·标准译文文件出处：USP38页次：20/20<659>PACKAGINGANDSTORAGEREQUIREMENTS<659>包装和储存要求(ChaptertobecomeofficialMay1,2016)（本章节2016年5月1号正式生效）Deletethefollowing：以下内容删除：EverymonographintheUSPandNFshallhavepackagingandstoragerequirements.Forthepackagingportionofthestatement,thechoiceofcontainersisgiveninthischapter.Fordrugproductpackagingrequirements,definitionsareprovidedtoguideselectionandadaptation.Foractivepharmaceuticalingredients(APIs),thechoicewouldbetight,well-closedor,whereneeded,alight-resistantcontainer.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.在USP和NF的每个专论中应要有包装和储存的要求。对于包装的声明部分，本章节提供了容器的选择。对于药品包装的要求，定义进行导向筛选和改编。对于API，要选择密封的、密闭性好的或者根据需要选择耐光的容器。对于赋形剂，和大容量商品一样，鉴于他们的典型性质，（容器从圆桶到罐车），默认是一个密闭性好的容器。Wherenospecificdirectionsorlimitationsareprovidedinthearticle’slabeling,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheatand,wherenecessary,fromlightduringshippinganddistribution.Drugsubstancesareexemptfromthisstandard.USP38.在物品的标签上没有提供特定的方向或局限性。物品在运输和配送过程中应该防潮、防冻、防过热，必要时要避光。药物不受这个标准限制。PACKAGING包装Packagingmustnotinteractphysicallyorchemicallywithofficialarticlesinanywaythatcausestheirsafety,identity,strength,quality,orpuritytofailtoconformtorequirements.包装不能以任何方式使物品化学和物理方面产生相互影响，从而导致他们的安全性、特性、强度、质量或纯度不符合要求。Packagingcontainerchoicesaregiveninthischapter.Fordrugproductsandactivepharmaceuticalingredients(APIs),thecontainerchoicesaretight,well-closed,or,whereneeded,light-resistant.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.Forarticlesotherthandrugsubstancesanddrugproducts,wherenospecificdirectionsorlimitationsareprovided,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheat,and,wherenecessary,fromlightduringshippinganddistribution.本章节提供了包装容器的选择。对于药品和API包装的要求，要选择密封的、密闭性好的或者根据需要选着耐光的容器。对于赋形剂，和大容量商品一样，鉴于他们的典型性质，（容器从圆桶到罐车），默认是一个密闭好的容器。没有提供特定的方向或局限性时，对于除了药物和药品外的其他物品，在运输和配送过程中应该防潮、防冻、防过热，必要时要避光。Thecompendialrequirementsfortheuseofspecifiedcontainersapplyalsotoarticlesaspackagedbythepharmacistorotherdispenser,unlessotherwiseindicatedintheindividualmonograph.USP38使用指定容器的药典要求对药剂师或其他分配者包装物品时同样适用，除非在专论中另有说明。GENERALDEFINITIONS一般概念Packagingsystem(alsoreferredtoasacontainer–closuresystem):Thesumofpackagingcomponentsthattogethercontainandprotectthearticle.Thisincludesprimarypackagingcomponentsandsecondarypackagingcomponents,ifthelatterisintendedtoprovideadditionalprotection.包装系统（也称为容器密封系统）：指共同盛装和保护物品的所有包装组件的总和。如果次级包装组件具有为物品提供额外保护的功能，则容器密封系统包括初级包装组件和次级包装组件。Container:Areceptaclethatholdsanintermediatecompound,activepharmaceuticalingredient,excipient,ordosageformandisormaybeUSP38indirectcontactwiththearticles.Theimmediatecontaineristhatwhichisindirectcontactwiththearticleatalltimes.Theclosureisapartofthecontainer.Beforebeingfilled,thecontainershouldbeclean.Specialprecautionsandcleaningproceduresmaybenecessarytoensurethateachcontaineriscleanandthatextraneousmatterisnotintroducedintoorontothearticle.USP38容器：能够保存中间体、原料药、辅料或剂型的容器，是或可能是和物品直接接触。直接包装的容器会一直直接接触药品。密封也是容器的一部分。在填装之前，容器应该干净。特殊的预防措施和清洁程序可能是必要的，可以保证每个容器的干净，异物不会引入或粘到药品上。Packagingcomponent:Anysinglepartofthepackageorcontainer–closuresystemincludingthecontainer(e.g.,ampuls,prefilledsyringes,vials,bottles);containerliners(e.g.,tubecartridgeliners);closures(e.g.,screwcaps,stoppers);ferrulesandoverseals;closureliners;innerseals;administrationports;overwraps;administrationaccessories;andlabels.包装组件：容器密封系统或包装的任何一个部分，包括容器（如：安瓿、预灌封注射器、西林瓶、瓶子）；容器衬垫（例如管衬）；瓶塞（螺旋盖、胶塞）；套管和胶塞顶封；瓶塞衬垫；内封；输液口；外包装；给药配件和标签。Primarypackagingcomponent:Packagingcomponentsthatareindirectcontactormaybecomeindirectcontactwiththearticle.初级包装组件指的是与物品直接接触或可能变成直接接触的包装组件。Secondarypackagingcomponent:Packagingcomponentsthatarenotandwillnotbeindirectcontactwiththearticle.USP38次级包装组件指的是不与物品直接接触的包装组件。Tertiarypackaging:Packagingcomponentsthatarenotindirectcontactwiththearticlebutfacilitatethehandlingandtransportinordertopreventdamagefromphysicalhandlingandstorageconditionstowhichthearticleissubjected.三级包装：包装组件不直接接触物品但是方便操作和运输，以避免来自物理操作和储存条件对物品产生的损害。Materialsofconstruction:Referstothematerials(e.g.,glass,plastic,elastomers,metal)usedtomanufactureapackagingcomponent.结构材料：指的是用于生产包装组件的材料（如：玻璃、塑料、弹性纤维、金属）。Multiple-dosecontainerUSP38(alsoreferredtoasmulti-dose):Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticleforparenteraladministrationwithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.SeeMulti-DoseContainersinContainerContentforInjections697.USP38多剂量容器（也称为多剂量）：允许药品连续部分取出进行非消化道给药的一个包装系统，不改变余下部分的安全、强度、质量或纯度。见<697>注射剂容器部分的多剂量容器。.Multiple-unitcontainer:USP38Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticlewithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.多单元包装容器：允许一个药品连续部分的取出的包装系统，不改变余下部分的安全、强度、质量或纯度。Single-unitcontainer：USP38Apackagingsystemthatholdsaquantityofanarticleintendedforadministrationasasingledoseorasinglefinisheddeviceintendedforusepromptlyafterthecontainerisopened.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingshallbesodesignedastoshowevidenceofanytamperingwiththecontents.USP38一次用容器：盛有一定量药品的包装系统，打开后能够作为单剂量或一次性给药的装置，在容器打开后能尽快使用。最好，应设计直接包装和/或外容器或保护性包装，以作为内容有任何篡改的证据。Single-dosecontainer:Asingle-dosecontainerisacontainerofsterilemedicationforparenteraladministration(injectionorinfusion)thatisnotrequiredtomeettheantimicrobialeffectivenesstestingcriteria.[Note—Forthisdefinitiononly,containerissynonymouswithpackagingsystemandcontainer–closuresystem.]Asingle-dosecontainerisdesignedforusewithasinglepatientasasingleinjection/infusion.1Asingle-dosecontainerislabeledassuchand,whenspacepermits,shouldincludeappropriatediscardinstructionsonthelabel.Examplesofsingle-dosecontainersarevials,ampuls,andprefilledsyringes.USP38单剂量容器：单剂量容器是用于注射用无菌药物（注射或输液）的一种容器，不需要满足抗菌效果的测试标准。[注意——只对于这个定义，容器是包装系统和容器密封系统代名词]。单剂量容器是为单个病人单次注射/输液使用的。单剂量容器贴上标签，当空间允许，应在标签包括适当的丢弃说明。典型的单剂量容器是西林瓶、安剖、预灌封注射器）。Unit-dosecontainer：USP38Asingle-unitpackagingsystemforanarticleintendedforadministrationbyotherthantheparenteralrouteasasingledose.单一剂量容器：除了非肠道给药，药品单剂量给药的一次用包装系统。Unit-of-usecontainer:USP38Apackagingsystemthatcontainsaspecificquantityofanarticlethatisintendedtobedispensedassuchwithoutfurthermodificationexceptfortheadditionofappropriatelabeling.Unit-of-usepackagingmaynotberepackagedforsale.单位使用容器：含有特定数量药品的包装系统，这些药品打算分发不能进一步修改，除了增加适当的标签。单位使用包装不能重新包装销售。Pharmacybulkpackage:ApackagingsystemUSP38ofasterilepreparationforparenteralusethatcontainsmanysingledoses.Thecontentsareintendedforuseinapharmacyadmixtureprogramandarerestrictedtothepreparationofadmixturesforinfusionor,throughasteriletransferdevice,forthefillingofemptysterilesyringes.药房大包装：含有多个单剂量注射用灭菌制剂的包装系统。其内容物用于药房调配且仅限于混合输液的配制或者通过灭菌传输装置，填充空的无菌注射器。Theclosureshallbepenetratedonlyonetimeafterconstitution,ifnecessary,USP38withasuitablesteriletransferdeviceordispensingsetthatallowsmeasureddispensingofthecontents.ThePharmacybulkpackageistobeusedonlyinasuitableworkareasuchasalaminarflowhood(oranequivalentclean-aircompoundingarea).组成药房大包装后只能刺穿封塞一次，如果必要，用一个合适的无菌传输设备或能够允许测量调配药量的配药装置。药房大包装只在合适的工作区域使用，如层流净化罩（或相同的空气洁净级别的区域）。DesignationasaPharmacybulkpackageislimitedtoInjection,forInjection,orInjectableEmulsiondosageformsasdefinedinNomenclature1121,GeneralNomenclatureForms.USP38药房大包装仅限于注射，注射或可注射乳剂剂型在1121通用术语形式中的术语里有定义。Pharmacybulkpackage,althoughcontainingmorethanonesingledose,isexemptfromthemultiple-dosecontainervolumelimitof30mLandtherequirementthatitcontainsasubstanceorsuitablemixtureofsubstancestopreventthegrowthofmicroorganisms.SeeLabeling7forlabelingrequirements.USP38药房大包装，虽然含有一个以上的单剂量，但不受多剂量包装30mL的体积限制，并不得含防止微生物生长的种物质或混合物。见7标签，对标签的要求。Small-volumeinjections:AninjectionthatUSP38ispackagedincontainerslabeledascontaining100mLorless.小容量注射剂：装入标示量为100mL或100mL以下容器的注射液。Large-volumeinjections:AnUSP38injectionthatisintendedforintravenoususe,andispackagedincontainerslabeledascontainingmorethan100mL.大容量注射剂：用于静脉注射使用，并装在标示量大于100mL容器的注射液。Child-resistantpackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbychildren(16CFR§1700.20).儿童安全包装：设计或构建的包装系统符合消费者产品安全委员会标准适合对儿童开放(16CFR§1700.20)。Senior-friendlypackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbysenioradults(16CFR§1700.20).老人适用型包装：设计或构建的包装系统符合消费者产品安全委员会标准适合对老年人开放。Tamper-evidentpackaging:USP38Apackagingsystemthatmaynotbeaccessedwithoutobviousdestructionofthesealorsomeportionofthepackagingsystem.Tamper-evidentpackagingshallbeusedforasterilearticleintendedforophthalmicoroticuse,exceptwhereextemporaneouslycompoundedforimmediatedispensingonprescription.Articlesintendedforsalewithoutprescriptionarealsorequiredtocomplywiththetamper-evidentpackagingandlabelingrequirementsoftheFDAwhereapplicable.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingusedbyamanufacturerordistributorforalldosageformsthatarenotspecificallyexemptisdesignedsoastoshowevidenceofanytamperingwiththecontents.防篡改包装：是指只有明显的破坏密封性或包装系统的部分才能取出内部产品的一种包装系统。防篡改包装应用于眼用或耳用无菌产品，除非为了立即调配处方的无准备混合。用于销售的非处方药也要求符合防篡改包装和适用于FDA的标签要求。对于所有剂型而言，最好应设计生产者或经销商所用的不能免除的直接包装和/或外包装或保护性包装，以作为内容有任何篡改的证据。Hermeticcontainer:Apackagingsystemthatisimpervioustoairoranyothergasundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.USP38密封容器：在处理、运输、存储和分布的普通或习惯性条件下不受空气或其他气体影响的包装系统。Tightcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneousliquids,solids,orvapors;fromlossofthearticle;andfromefflorescence,deliquescence,orevaporationundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistributionandiscapableoftightreclosure.Whereatightcontainerisspecified,itmaybereplacedbyahermeticcontainerforasingledoseofanarticle.[Note—Wherepackagingandstorageinatightcontainerorwell-closedcontainerisspecifiedintheindividualmonograph,thecontainerusedforanarticlewhendispensedonprescriptionmeetstherequirementsinContainers—PerformanceTesting671.]USP38紧密容器：在处理、运输、存储和分布的普通或习惯性条件下避免药品受外来液体、固体或蒸汽的污染；避免药品损失和风化、潮解或蒸发且能够密封的包装系统，且该包装系统可以重新紧密包装。密闭容器是指定的，用于单剂量药物时可以被密封容器取代。[注意——药品包装和储存的密闭容器或专论中指定的密封容器，当分配处方时，药物所使用的容器符合671容器-性能测试的要求。Well-closedcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneoussolidsUSP38andfromlossofthearticleundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.SeeContainers—PerformanceTesting671.密封容器：在处理、运输、存储和分布的普通或习惯性条件下避免药品受到外来固体污染，避免药品损失的包装系统。见671容器-性能测试。Light-resistantcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromtheeffectsoflightbyvirtueofthespecificpropertiesofthematerialofwhichitiscomposed,includinganycoatingappliedtoit.Aclearandcolorlessoratranslucentcontainermaybemadelight-resistantbymeansofanopaquecoveringorbyuseofsecondarypackaging,inwhichcasethelabelofthecontainerbearsastatementthattheopaquecoveringorsecondarypackagingisneededuntilthearticlesaretobeusedoradministered.Whereitisdirectedto“protectfromlight”inanindividualmonograph,preservationinalight-resistantcontainerisintended.SeeContainers—PerformanceTesting671,LightTransmissionTest.耐光容器：由特定性能材料组成能保护药物不受光的影响的包装系统，包括所使用的任何涂层。清晰和无色或半透明容器可以通过一个不透明的覆盖方法制成耐光的，或用于次级包装。在这种情况下，容器的标签必需要有不透明的覆盖物或次级包装的声明，直到药品被使用或给药。专论中针对“闭光”，要求保存在耐光容器。见671容器-性能测试，光传输测试。Blackclosuresystemorblackbands:Theuseofablackclosuresystemonavial(e.g.,ablackcapoversealandablackferruletoholdtheelastomericclosure)ortheuseofablackbandorseriesofbandsabovetheconstrictiononanampulisprohibited,exceptforPotassiumChlorideforInjectionConcentrate.SeeLabeling7.USP38黑色密封系统或黑色封边：除了氯化钾浓缩注射液外，在小瓶上使用黑色密封系统（如：黑色顶封盖和黑色金属箍来维持橡胶塞）或安瓿上使用黑色封边或一系列封边均是被禁止的。见7标签。Addthefollowing:以下是增加的内容：INJECTIONPACKAGING注射液包装Validationofcontainer–closureintegritymustdemonstratenopenetrationofmicrobialcontaminationorchemicalorphysicalimpurities.Inaddition,thesolutesandthevehiclemustmaintaintheirspecifiedtotalandrelativequantitiesorconcentrationswhenexposedtoanticipatedextremeconditionsofmanufacturingandprocessing,storage,shipment,anddistribution.Closuresformultiple-dosepackagingsystemspermitthewithdrawalofthecontentswithoutremovalordestructionoftheclosure.Theclosurepermitspenetrationbyaneedleand,uponwithdrawaloftheneedle,closesatonce,protectingthecontentsagainstcontamination.Validationofthemultiple-dosecontainer–closureintegritymustincludeverificationthatsuchapackagepreventsmicrobialcontaminationorlossofproductcontentsunderanticipatedconditionsofmultipleentryanduse.容器密封完整性验证必须证明没有微生物污染或化学或物理杂质的进入。除此之外，当容器暴露于生产和加工、储存、运输和销售的极端环境下时，溶质和溶剂必须保持其标示总量和相对量或浓度。多剂量包装系统的封塞应能在不除去或毁坏封塞的情况下抽出内容物。塞子可被针头刺入，当抽出针头时，应立即封闭容器以防污染。多剂量容器密封完整性验证必须包括确认此包装在多次刺入和使用的预期条件下能够防止微生物污染或者产品含量的损失。Piggybackpackagingsystemsareusuallyintravenousinfusioncontainer–closuresystemsusedtoadministerasecondinfusionthroughaconnectorofsometypeoraninjectionportontheadministrationsetofthefirstfluid,therebyavoidingtheneedforanotherinjectionsiteonthepatient'sbody.Piggybackpackagingsystemsalsoareknownassecondaryinfusioncontainers.便携式包装系统通常是静脉输液容器密封系统，该系统通过多种类型的连接器或第一次输注给药的装置的注射孔进行第二次输注给药，因此避免了在病人身上在此寻找注射位置。便携式包装系统也被称为第二次输注容器。Thevolumeofinjectioninasingle-dosepackagingsystemprovidestheamountspecifiedforone-timeparenteraladministrationandinnocaseismorethansufficienttopermitthewithdrawalandadministrationof1L.单剂量包装系统注射液的容量规定了一次性注射用指定的数量，并在任何情况下，足以允许1L的抽取和给药量。Preparationsintendedforintraspinal,intracisternal,orperiduraladministrationarepackagedonlyinsingle-dosepackagingsystems.脊柱内注射、脑池液注射或硬膜外注射给药的制剂，只能灌装在单剂量容器中。Unlessotherwisespecifiedintheindividualmonograph,amultiple-dosepackagingsystemcontainsavolumeofinjectionsufficienttopermitthewithdrawalofNMT30mL.除非专论另有规定，多剂量包装系统含有的可抽出注射液体积不得超过30ml。Thefollowinginjectionsareexemptfromthe1-Lrestrictionoftheforegoingrequirementsrelatingtopackaging:以下的注射液不受上述关于包装的1L要求的限制。Injectionspackagedforextravascularuseasirrigationsolutionsorperitonealdialysissolutions.灌洗用或腹膜透析用的血管外注射液包装。Injectionspackagedforintravascularuseasparenteralnutritionorasreplacementorsubstitutionfluidtobeadministeredcontinuouslyduringhemofiltration.胃肠外营养用或血液过滤期间不断给药的置换液用的血管内注射液包装。Injectionspackagedforintravascularusethatmaybeusedforintermittent,continuous,orbolusreplacementfluidadministrationduringhemodialysisorotherprocedures,unlessexceptedabove,mustconformtothe1-Lrestriction.Injectionslabeledforveterinaryuseareexemptfrompackagingandstoragerequirementsconcerningthelimitationtosingle-dosepackagingsystemsandthelimitationonthevolumeofmultiple-dosecontainers.在血液透析或其他程序过程中可能用于间歇性、连续性或大剂量更换给药的血管内注射液的包装必须符合1L限制，除非不属于以上条件。兽用标记的注射器不受关于单剂量包装系统和多剂量容器体积限制的包装和储存要求。Sterilesolidspackaging:Containers,includingtheclosures,fordrysolidsintendedforinjectiondonotinteractphysicallyorchemicallywiththepreparationinanymannertoalterthestrength,quality,orpuritybeyondtheofficialrequirementsundertheordinaryorcustomaryconditionsofhandling,shipment,storage,sale,anduse.Apackagingsystemforasterilesolidpermitstheadditionofasuitablesolventandwithdrawalofportionsoftheresultingsolutionorsuspensioninsuchmannerthatthesterilityoftheproductismaintained.WheretheAssayinamonographprovidesaprocedurefortheSamplesolution,inwhichthetotalwithdrawablecontentsaretobewithdrawnfromasingle-dosepackagingsystemwithahypodermicneedleandsyringe,thecontentsaretobewithdrawnascompletelyaspossibleintoadryhypodermicsyringeofaratedcapacitynotexceedingthreetimesthevolumetobewithdrawnandfittedwitha21-gaugeneedleNLT2.5cm(1inch)inlength,withcarebeingtakentoexpelanyairbubbles,anddischargedintoacontainerfordilutionandassay.USP38无菌固体包装：用于注射给药干燥固体的容器，包括封塞，不应与制剂产生物理或化学的相互作用以致在规定或通常处理、运输、存储、销售及使用中以任何方式对强度、质量和纯度超出法定要求。无菌固体包装系统允许加入适宜的溶剂，抽出制成的溶液或悬浮液部分，这样能保持产品的无菌度。在专论的“含量测定”中规定样品溶液程序，规定用皮下注射针头和注射器从单剂量容器中抽出全部内容物，应尽可能完全地抽出，抽到干燥的皮下注射器中，注射器的标示容量不得超过抽出量的3倍，并应装长度不少于2.5cm（1英寸）的21号针头，小心排出气泡，转移入一个容器进行稀释和测定。MEDICALGASPACKAGING药用气体包装Gascylinder:Agascylinderisametallicpackagingsystemconstructedofsteeloraluminumdesignedtoholdmedicalgasesunderpressure.MedicalgasesincludeCarbonDioxideUSP,HeliumUSP,MedicalAirUSP,nitricoxide,NitrousOxideUSP,NitrogenNF,andOxygenUSP.Asasafetymeasure,forcarbondioxide,cyclopropane,helium,medicalair,nitrousoxide,andoxygen,thePin-IndexSafetySystemofmatchedfittingsisrecommendedforcylindersofSizeEorsmaller.气瓶：气瓶是一个金属包装系统，由钢或铝构成，在压力下用来保存医疗气体。医疗气体包括二氧化碳USP,医用空气USP,一氧化氮,一氧化二氮USP,氮气NF和氧气USP。Pin-Index安全系统作为一项安全措施，为二氧化碳、环丙烷、氦、医疗空气、一氧化二氮和氧推荐的匹配配件是型号为E或更小的气瓶。ASSOCIATEDCOMPONENTS相关组件Manyassociatedcomponentsaregraduatedfordoseadministration.Itistheresponsibilityofthemanufacturertoensurethattheappropriatedosingcomponentisprovidedorthatageneralpurposecomponent,suchasthosedescribedinthissection,isspecifiedfordeliveringtheappropriatedosewiththeintendedaccuracy.Thegraduationsshouldbelegibleandindelible.许多相关组件根据给药剂量是有刻度的。厂家有责任确保提供符合剂量的组件或通用组件，如这个章节所描述的那些组件，用于发放适当的剂量，在预期的准确度里。刻度应该是清晰的，不可磨灭的。Graduatedassociatedcomponentsdescribedinthissectionareforgeneraluse.Graduatedmarkingsshouldbelegible,indelible,andonanextraoralnonproductcontactsurface.Underidealconditionsofuse,thevolumeerrorincurredinmeasuringliquidsforindividualdoseadministrationbymeansofsuchgraduatedcomponentsshouldbeNMT10%oftheindicatedamountoftheliquidpreparationwithwhichthegraduatedcomponentwillbeused.Fewliquidpreparationshavethesamesurfaceandflowcharacteristics.Therefore,thevolumedeliveredvariesmateriallyfromonepreparationtoanother.本章节所描述的有刻度的相关组件是普遍使用的。刻度标记应该是清晰，不可磨灭的，且在产品不能接触的外表面。在理想的使用条件下，单剂量给药时用这些刻度组件测量液体所招致的体积误差小于等于10%，表示在有刻度元件内的液体制剂的量是可用的。一些液体制剂具有相同的表面和流动特性。因此，从一个制剂到另一个制剂的输液量实际上是不同的。PolymersandingredientsaddedtopolymersthatareusedinthefabricationofassociatedcomponentsmustconformtotherequirementsintheapplicablesectionsoftheCodeofFederalRegulations,Title21,IndirectFoodAdditives.用于制造相关组件的聚合物和添加到聚合物的材料必须符合美国联邦法规，标题21，间接食品添加剂适用章节的要求。Dosingcup:Ameasuringdeviceconsistingofasmallcupthatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.加药杯：由一个包装口服液体药物的小杯子组成的一个测量容器，也可以单独出售和购买。Dosingspoon:Ameasuringdeviceconsistingofabowlandahandlethatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.Thehandlemaybeagraduatedtube.加药匙：由一个包装口服液体药物的碗状物和手柄组成的一个测量容器，也可以单独出售和购买。柄可能是个刻度管。Medicinedropper:Ameasuringdeviceconsistingofatransparentortranslucentbarrelortubethatisgenerallyfittedwithacollapsiblebulb.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.医药用滴管:由透明或半透明的枪管或管组成的测量容器，通常配有一个可折叠的球状物。包装口服液体药物，可以单独出售和购买。Dropperstypicallyvaryincapacity;however,thedeliveryendshouldbearoundopeninghavinganexternaldiameterofabout3mm.Thebarrelmaybegraduated.[Note—Fewmedicinalliquidshavethesamesurfaceandflowcharacteristicsaswater,andthereforethesizeofdropsvariesmateriallyfromonepreparationtoanother.]滴管通常在容量上是多变的，然而，出口端应该是一个外直径为3mm的圆孔。枪管要有刻度。[注意——一些药用液体具有和水相同的表面和流量特性，因此，从一个制剂到另一个制剂的滴量实际上是变化的]。Oralsyringe:Ameasuringdeviceconsistingofaplungerandbarrelmadeofsuitablerigid,transparentortranslucentplasticmaterialandasealontheend.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.Thesyringeshouldexpelameasuredamountofaliquidarticledirectlyintothepatient'smouth.Fingergripslocatedattheopenendofthebarrelshouldbetheappropriatesize,shape,andstrength,andshouldallowthesyringetobeheldsecurelyduringuse.Thebarrelmaybegraduated.口腔注射器：由一个活塞和刚性适合的透明或半透明塑料制成的管组成的测量容器，且在末端封口。用于包装口服液体药品或者可以单独出售和购买。注射器可以将被测量液体直接进注入病人的嘴。位于筒开口端的指套应有适当的大小，形状，和力量，且应该允许注射器在使用期间能够保持安全牢固。管需要标刻度。Teaspoon:Ameasuringdeviceconsistingofashallowbowl,ovalorround,attheendofahandle.Ateaspoonhasbeenestablishedascontaining4.93±0.24mL.Forthepracticeofadministeringarticles,theteaspoonmayberegardedasrepresentingavolumeof5mL.茶匙：是由一个圆形或椭圆形的，末端有个柄的浅碗组成。既定的茶匙有4.93±0.24mL。根据药物给药的实践，茶匙可以被视为是5mL的量。Articlesintendedforadministrationbyteaspoonshouldbeformulatedonthebasisofdosagein5-mLunits,suchthatanycomponentusedtoadministerliquidarticlesshoulddeliver5mLwhereverateaspooncalibrationisindicated.Ahouseholdspoonisnotanacceptablealternativetothegraduatedteaspoondescribedherein.用茶匙给药的药物应该建立在用量是5-mL每单元的基础上。这样任何用于液体药品给药的元件应该提供5mL，无论有没有指明茶匙要校准。家里的勺子不能代替这里所描述的有标量的茶匙。POISONPREVENTIONPACKAGINGACT(PPPA)防毒包装法案（PPPA）Thisactrequiresspecialpackagingofmosthumanoralprescriptiondrugs,oralcontrolleddrugs,certainnon-oralprescriptiondrugs,certaindietarysupplements,andmanyover-the-counter(OTC)drugpreparationsinordertoprotectthepublicfrompersonalinjuryorillnessfrommisuseofthesepreparations(16CFR§1700.14).该法案要求对大多数人用口服处方药，口服控制药物，某些非口服处方药，某些膳食补充剂，以及很多非处方药（OTC）的药物制剂进行特殊包装，其目的是为了保护公众免受滥用这些制剂带来的人身伤害或疾病（参考16CFR§1700.14）。TheimmediatepackagingofsubstancesregulatedunderthePPPAmustcomplywiththespecialpackagingstandards(16CFR§1700.15and16CFR§1700.16)andappliestoallpackagingtypesincludingreclosable,nonclosable,andunit-dosetypes.在防毒包装法案（PPPA）监管下，直接接触药物的包装必须符合特殊包装标准（参考16

CFR

§1700.15

和16

CFR

§1700.16），且适用于包括可重新密封、不可密封和单位剂量类型所有包装类型。Specialpackagingisnotrequiredeitherfordrugsdispensedwithinahospitalsettingforinpatientadministrationorbymanufacturersandpackagersofbulk-packagedprescriptiondrugsrepackagedbythepharmacist.PPPA-regulatedprescriptiondrugsmaybedispensedinnonchild-resistantpackagingupontherequestofthepurchaserorwhendirectedinalegitimateprescription(15U.S.C.§1473).无论是为住院病人管理设置的医院内用药量，还是药师重新包装由生产商和包装商散装包装的处方药都不需要特殊包装。基于采购人的要求，或者当一个合法的处方指导时，PPPA监管的处方药可能分配到非儿童安全包装。（参考15

U.S.C.

§1473）ManufacturersorpackagersofPPPA-regulatedOTCpreparationsareallowedtopackageonesizeinnonchild-resistantpackagingaslongaspopular-size,specialpackagesarealsosupplied.Thenonchild-resistantpackagingrequiresspeciallabeling(16CFR§1700.5).允许PPPA监管的OTC制剂的生产商或包装商包装一个非儿童安全包装尺寸，只要这个尺寸受欢迎，也可以提供特殊包装。非儿童安全包装需要特殊标签。（参考16

CFR

§1700.5）Changetoread:STORAGECONDITIONS储存条件Specificdirectionsarestatedinsomemonographswithrespecttostorageconditions,e.g.,thetemperatureorhumidityatwhichanarticlemustbestoredandshipped.Suchdirectionsapply,exceptwherethelabelonthearticlehasdifferentstorageconditionsthatarebasedonstabilitystudies.Wherenospecificstorageconditionsareprovidedintheindividualmonograph,butthelabelofanarticlestatesstorageconditionsbasedonstabilitystudies,suchlabeledstoragedirectionsapply.USP38在一些专论中对储存条件有一些特定的规定，如药物储存和运输必需的温度和湿度。这些方向的应用，除了在药物的标签上有不同的储存条件，也建立在稳定性研究的基础上。在专论上没有提供特定储存条件，但是药物标签上的储存条件，建在稳定性的基础上，这样标为储存方向适用。Freezer:Aplaceinwhichthetemperatureismaintainedbetween-25°and-10°(-13°and-14°F).冷冻箱：温度维持在-25°到-10°之间的地方（-13°和-14°F）。Refrigerator:AcoldUSP38placeinwhichthetemperatureismaintainedbetween2°and8°(36°and46°F).冰箱：温度维持在2°和8°之间的一个寒冷的地方（36°和46°F)Cold:Anytemperaturenotexceeding8°(46°F).冷冻：不超过8°的任意温度(46°F)。Cool:Anytemperaturebetween8°and15°(46°and59°F).[Note—Anarticleforwhichstorageinacoolplaceisdirectedmay,alternatively,bestoredandshippedasrefrigerated,unlessotherwisespecifiedbytheindividualmonograph.]阴凉：8°和15°(46°和59°F)之间的任意温度。[注意——储存阴凉处的药物直接或者用冰箱储存或运输。除非专论另有规定]。Roomtemperature:Thetemperatureprevailinginaworkarea.室温：一般工作区域的温度。Controlledroomtemperature:ThetemperaturemaintainedthermostaticallythatencompassesUSP38attheusualandcustomaryworkingenvironmentof20°–25°(68°–77°F).Thefollowingconditionsalsoapply.控制的室温：温度保持自动调温，包括20°–25°(68°–77°F)的习惯性工作环境。下列的条件同样适用。Meankinetictemperaturenottoexceed25°.USP38Excursionsbetween15°and30°(59°and86°F)thatareexperiencedinpharmacies,hospitals,andwarehouses,andduringshippingareallowed.ProvidedUSP38themeankinetictemperaturedoesnotexceed25°,transientU