药典凡例-印度药典(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GENERALNOTICES凡例JP2022GeneralStatements总则TheGeneralNoticesprovidethebasicguidelinesfortheinterpretationandapplicationofthestandards,tests,assays,andotherspecificationsoftheIndianPharmacopoeia(IP),aswellastothestatementsmadeinthemonographsandothertextsofthePharmacopoeia.凡例为印度药典（IP）标准、试验、测定及其他规格要求的解释与应用，以及药典正文中的各项表述和其他文本内容，提供基本指导原则。Amonographistobeconstructedinaccordancewithanygeneralmonographornoticeoranyappendix,noteorotherexplanatorymaterialthatiscontainedinthisPharmacopoeiaandthatisapplicabletothatmonograph.Allstatementscontainedinthemonograph,exceptwhereaspecificgeneralnoticeindicatesotherwiseandwiththeexceptionsgivenhereafter,constitutestandardsfortheofficialarticles.Anarticleisnotofpharmacopoeialqualityunlessitcomplieswithalloftherequirementsstated.正文的编写应符合本药典中适用于该正文的通则、凡例、附录、注释或其他解释性内容的要求。除特定凡例另有说明及下文所列例外情况外，正文中的所有表述均构成法定药品的标准。药品必须符合所有规定要求，方可视为符合药典级质量。ExceptionstotheGeneralNoticesdoexist,andwheretheydo,thewordingintheindividualmonographoranappendixtakesprecedenceandspecificallyindicatesdirectionsortheintent.Thus,thespecificwordingofstandards,tests,assaysandotherspecificationsisbindingwhereverdeviationsfromtheGeneralNoticesexist.Likewise,wherethereisnospecificmentiontothecontrary,theGeneralNoticesapply.凡例存在例外情况，当出现例外时，以具体正文或附录中的表述为准，该表述将明确说明相关要求或意图。因此，凡与凡例不一致之处，标准、试验、测定及其他规格要求的具体表述具有约束力；同理，无特殊相反说明时，凡例均适用。NameThefullnameortitleofthisbook,includingaddendathereto,isIndianPharmacopoeia2022,abbreviatedtoIP2022.Inthetexts,theterm“Pharmacopoeia”or“IP”withoutqualificationmeanstheIndianPharmacopoeia2022andanyamendmentsthereto.名字本书全称（含增补本）为《印度药典2022年版》，缩写为IP2022。正文中未特别限定的“药典”或“IP”一词，均指《印度药典2022年版》及其任何修订版。OfficialandOfficialArticlesTheword‘official’whereverusedinthisPharmacopoeiaorwithreferencethereto,issynonymouswith‘pharmacopoeial’,with‘IP’andwith‘compendial’.ThedesignationIPinconjunctionwiththeofficialtitleonthelabelofanarticleisanindicationthatthearticlepurportstocomplywithIPstandards.法定药品及法定药品条目本药典中凡使用“法定”一词，或涉及该表述时，均与“药典级”“IP”及“药典收载”同义。药品标签上标注的法定名称旁附有“IP”标识，表明该药品声称符合印度药典标准。Thefollowingtermsareusedwherethearticlesforwhichmonographsareprovidedaretobedistinguished.Anofficialsubstanceisasingledrugoradrugentityorapharmaceuticalaidforwhichthemonographtitleincludesnoindicationofthenatureofadosageform.Anofficialpreparationisadrugproduct(dosageform)andisthefinishedorpartiallyfinishedpreparationorproductofoneormoreofficialsubstancesformulatedforuseonthepatient.Anarticleisanitemforwhichamonographisprovided,whetheranofficialsubstanceoranofficialpreparation.对于药典正文收载的各类药品，采用以下术语加以区分：法定物质指单一药物、药物实体或药用辅料，其正文标题中未注明剂型属性；法定制剂指药物制品（剂型），是由一种或多种法定物质配制而成、供患者使用的成品或半成品制剂；药品指正文收载的各类物品，包括法定物质和法定制剂。OfficialStandardsTherequirementsstatedinthemonographsapplytoarticlesthatareintendedformedicinalusebutnotnecessarilytoarticlesthatmaybesoldunderthesamenameforotherpurposes.法定标准正文中的要求适用于药用药品，对于以相同名称销售但用于其他用途的物品，不一定适用。AnarticleisnotofPharmacopoeialqualityunlessitcomplieswithalltherequirementsstatedinthemonograph.ThisdoesnotimplythatperformanceofallthetestsinamonographisnecessarilyaprerequisiteforamanufacturerinassessingcompliancewiththePharmacopoeiabeforereleaseofaproduct.除非某药品符合各论中规定的所有要求，否则该药品即不属于药典质量。但这并不意味着生产商在产品放行前评估其是否符合药典要求时，必须执行各论中的所有测试。Pharmacopoeialrequirementsforarticlesusedinveterinarymedicineareestablishedonthesamebasisasthoseusedinhumanmedicine.Itshouldbenotedthatnorequirementinthepharmacopoeiacanbetakeninisolation.Avalidinterpretationofanyparticularrequirementdependsuponitbeingreadincontextofthemonographasawhole,thespecifiedmethodofanalysis,therelevantGeneralNoticesandwhereappropriatetheGeneralMonographs.兽药的药典要求与人体用药的药典要求基于相同原则制定。需注意，药典中的任何要求均不可孤立解读。对任一特定要求的有效解读，均需结合完整各论、规定的分析方法、相关凡例及（如适用）通则进行。WhereapreparationthatisthesubjectofamonographintheIndianPharmacopoeiaissuppliedforuseinveterinarymedicine,thestandardsofIndianPharmacopoeiaapplyunlessotherwisejustifiedandauthorized.若印度药典正文收载的制剂供兽医使用，除非有正当理由并经批准，否则应符合印度药典标准。Theactivepharmaceuticalingredients(drugsubstances),excipients(pharmaceuticalaids),pharmaceuticalpreparations(dosageforms)andotherarticlesdescribedinthemonographsareintendedforhumanandveterinaryuse(unlessexplicitlyrestrictedtooneoftheseuses).Itmaybenoted,however,thatintheeventofdoubtofinterpretationinanytextofVeterinarymonographsofIP,IndianPharmacopoeiaCommission(IPC)shouldbeconsulted.正文中描述的原料药、辅料（药用辅料）、药物制剂（剂型）及其他物品，均适用于人体和兽医使用（除非明确限定仅适用于其中一种用途）。但需注意，若对印度药典兽医正文的任何内容解读存在疑问，应咨询印度药典委员会（IPC）。Therequirementsgiveninthemonographsarenotframedtoprovideagainstallpossibleimpurities,contaminantsoradulterants;theyprovideappropriatelimitationofpotentialimpuritiesonly.正文中的要求并非为防范所有可能的杂质、污染物或掺杂物而制定，仅对潜在杂质规定了适当限度。Apreparationmustcomplywiththerequirementsspecified,throughoutitsshelf-lifeassignedtoitbythemanufacturer.Foropenedorbroachedcontainers,themaximumperiodofvalidityforusewillbeasmaybestatedintheindividualmonograph.Nevertheless,theresponsibilityforassigningtheperiodofvalidityshallbewiththemanufacturer.制剂必须在生产商规定的整个有效期内符合规定的要求。对于已开启或已开封的容器装制剂，其最长使用有效期应按照各论中的规定执行。不过，确定有效期的责任应由生产商承担。AddedSubstancesAnofficialsubstance,asdistinguishedfromanofficialpreparation,containsnoaddedsubstancesexceptwhenspecificallypermittedintheindividualmonograph.Unlessotherwisespecifiedintheindividualmonograph,orelsewhereintheGeneralNotices,suitablesubstancesmaybeaddedtoanofficialpreparationtoenhanceitsstability,preserveitsproperties,usefulnessorelegance,ortofacilitateitspreparation.Suchauxiliarysubstancesshallbeharmlessintheamountsused,shallnotexceedtheminimumquantityrequiredtoprovidetheirintendedeffect,shallnotimpairthetherapeuticefficacyorthebioavailabilityorsafetyofthepreparationandshallnotinterferewithanyofthetestsandassaysprescribedfordeterminingcompliancewiththeofficialstandards.Particularcareshouldbetakentoensurethatsuchsubstancesarefreefromharmfulorganisms.Thefreedomtothemanufacturerstoaddauxiliarysubstancesimposesonthemtheresponsibilityofsatisfyingthelicensingauthoritiesonthepurposeoftheadditionandtheinnocuityofsuchsubstances.Nosubstanceshallbeaddedtoconcealanydefectordamageordeficiencyinthesubstanceorformulation.外加物质与法定制剂不同，法定物质不得添加任何物质，除非具体正文明确允许。除非具体正文或凡例其他部分另有规定，可在法定制剂中添加适宜物质，以增强其稳定性、保持其特性、实用性或外观，或便于制剂制备。此类辅助物质在使用剂量下应无毒害，用量不得超过实现其预期效果所需的最低量，不得降低制剂的治疗效果、生物利用度或安全性，且不得干扰为判定是否符合法定标准而规定的任何试验和测定。应特别注意确保此类物质不含有害微生物。制造商有权添加辅助物质，但需向许可机构说明添加目的及该物质的无害性，并对此承担责任。不得添加任何物质以掩盖该物质或制剂中的缺陷、损坏或不足。AlternativeMethodsThetestsandassaysdescribedaretheofficialmethodsuponwhichthestandardsofthePharmacopoeiaarebased.Alternativemethodsofanalysismaybeusedforcontrolpurposes,providedthatthemethodsusedareshowntogiveresultsofequivalentaccuracyandenableanunequivocaldecisiontobemadeastowhethercompliancewiththestandardsofthemonographswouldbeachievediftheofficialmethodswereused.Automatedproceduresutilisingthesamebasicchemistryasthetestproceduresgiveninthemonographmayalsobeusedtodeterminecompliance.Suchalternativeorautomatedproceduresmustbevalidatedandaresubjecttoapprovalbytheauthoritycompetenttoauthorizemanufacturerofsubstanceorproduct.替代方法所述试验和测定方法为法定方法，是药典标准的依据。可采用替代分析方法进行质量控制，但需证明该方法所得结果的准确性与法定方法相当，且能明确判定若采用法定方法时该药品是否符合正文标准。采用与正文试验方法基本化学原理一致的自动化流程，也可用于判定是否符合标准。此类替代方法或自动化流程必须经过验证，并经有权批准该物质或产品制造商的机构批准。Intheeventofdoubtordispute,themethodsofanalysisofthePharmacopoeiaarealoneauthoritativeandonlytheresultobtainedbytheproceduregiveninthisPharmacopoeiaisconclusive.若存在疑问或争议，仅药典规定的分析方法具有权威性，且只有通过本药典规定流程获得的结果才具有决定性。MeaningsofTerms术语含义AlcoholTheterm“alcohol”withoutqualificationmeansethanol(95percent).Otherdilutionsofethanolareindicatedbytheterm“ethanol”or“alcohol”followedbyastatementofthepercentagebyvolumeofethanol(C₂H₆O)required.注明所需乙醇（C₂H₆O）的体积百分比。DesiccatorAtightly-closedcontainerofsuitablesizeanddesignthatmaintainsanatmosphereoflowmoisturecontentbymeansofsilicagelorphosphoruspentoxideorothersuitabledesiccant.干燥器指密封性良好、尺寸和设计适宜的容器，通过硅胶、五氧化二磷或其他适宜干燥剂维持低湿度环境。DryingandignitiontoconstantweightTwoconsecutiveweighingsafterthedryingorignitingoperationsdonotdifferbymorethan0.5mg,thesecondweighingfollowinganadditionalperiodofdryingorofignitionrespectivelyappropriatetothenatureandquantityoftheresidue.干燥并炽灼至恒重指干燥或炽灼操作后，连续两次称量的差值不超过0.5毫克，第二次称量需在根据残渣性质和数量确定的额外干燥或炽灼时间后进行。EthanolTheterm“ethanol”withoutqualificationmeansanhydrousethanolorabsolutealcohol.“乙醇”（ethanol）一词未特别限定状态时，指无水乙醇。FiltrationUnlessotherwisestated,filtrationisthepassingofaliquidthroughasuitablefilterpaperorequivalentdeviceuntilthefiltrateisclear.除非另有说明，过滤指将液体通过适宜滤纸或等效装置，直至滤液澄清。FreshlypreparedMadenotmorethan24hoursbeforeitisused.指使用前24小时内制备。LabelAnyprintedpackingmaterial,includingpackageinsertsthatprovideinformationonthearticle.指任何印有药品相关信息的包装材料，包括说明书。NegligibleAquantitynotexceeding0.50mg.指不超过0.50毫克的量。SolutionWherethenameofthesolventisnotstated,“solution”impliesasolutioninwater.ThewaterusedcomplieswiththerequirementsofthemonographonPurifiedWater.未注明溶剂名称时，“溶液”指水溶液。所用水分需符合“纯化水”正文的要求。TemperatureThesymbol°usedwithoutqualificationindicatestheuseoftheCelsiusthermometricscale.未特别限定的温度符号“°”指摄氏温度。WaterIfthetermisusedwithoutqualificationitmeansPurifiedWaterofthePharmacopoeia.Theterm‘distilledwater’indicatesPurifiedWaterpreparedbydistillation.“水”一词未特别限定类型时，指本药典中的纯化水。“蒸馏水”指通过蒸馏法制备的纯化水。Water-bathAbathofboilingwaterunlesswateratanothertemperatureisindicated.Othermethodsofheatingmaybeusedprovidedtherequiredtemperatureisapproximatelymaintainedbutnotexceeded.指沸水浴，除非注明其他温度。可采用其他加热方式，但需大致维持所需温度且不超过该温度。ProvisionsApplicableToMonographsandTestMethods适用于各论和检验方法的规定ExpressionofContentsWherethecontentofasubstanceisdefined,theexpression“percent”isusedaccordingtocircumstanceswithoneoftwomeanings:当规定某物质的含量时，“百分比”（percent）根据情况具有以下两种含义之一：percentw/w(percentage,weightinweight)expressingthenumberofgramsofsubstancein100gramsoffinalproduct,重量百分比（w/w）指每100克最终产品中含该物质的克数；percentv/v(percentage,volumeinvolume)expressingthenumberofmillilitresofsubstancein100millilitresoffinalproduct.体积百分比（v/v）指每100毫升最终产品中含该物质的毫升数。Theexpression“partspermillion”referstotheweightinweight,unlessotherwisestated.“百万分之”（partspermillion）除非另有说明，均指重量百分比。Wherethecontentofasubstanceisexpressedintermsofthechemicalformulaforthatsubstanceanupperlimitexceeding100percentmaybestated.Suchanupperlimitappliestotheresultoftheassaycalculatedintermsoftheequivalentcontentofthespecifiedchemicalformula.Forexample,thestatement‘containsnotlessthan99.0percentandnotmorethan101.0percentofC₇H₆O₂impliesthattheresultoftheassayisnotlessthan99.0percentandnotmorethan101.0percent,calculatedintermsoftheequivalentcontentofC₇H₆O₂.当某物质的含量以其化学式表示时，允许规定超过100%的上限。该上限适用于以规定化学式的等效含量计算得出的含量测定结果。例如，“含C₇H₆O₂不得少于99.0%，且不得超过101.0%”，指以C₇H₆O₂的等效含量计算，含量测定结果应在99.0%~101.0%之间。Wheretheresultofanassayortestisrequiredtobecalculatedwithreferencetothedried,anhydrous,ignitedsubstance,orthesubstancefreefromsolvent,thedeterminationoflossondrying,watercontent,lossonignition,contentofthespecifiedsolvent,respectivelyiscarriedoutbythemethodprescribedintherelevanttestinthemonograph.若含量测定或试验结果需以干燥品、无水物、炽灼残渣或无溶剂物为基准计算，则需分别采用正文相关试验中规定的方法测定干燥失重、水分、炽灼失重或规定溶剂的含量。ExpressionofConcentrationsThefollowingexpressionsinadditiontotheonesgivenunderExpressionofContentarealsoused:除含量表示方法外，还使用以下浓度表示方法：percentw/v(percentage,weightinvolume)expressingthenumberofgramsofsubstancein100millilitresofproduct,重量体积百分比（w/v）指每100毫升产品中含该物质的克数；percentv/w(percentage,volumeinweight)expressingthenumberofmillilitresofsubstancein100gramsofproduct.体积重量百分比（v/w）指每100克产品中含该物质的毫升数。Usually,thestrengthofsolutionsofsolidsinliquidsisexpressedaspercentageweightinvolume,ofliquidsinliquidsaspercentagevolumeinvolume,ofsolidsinsemi-solidbases(e.g.creams)andofgasesinliquidsaspercentageweightinweight.通常，固体在液体中的溶液浓度以重量体积百分比表示，液体在液体中的溶液浓度以体积百分比表示，固体在半固体基质（如乳膏）中的浓度及气体在液体中的浓度以重量百分比表示。Whentheconcentrationofasolutionisexpressedaspartsofdissolvedsubstanceinpartsofsolution,itmeanspartsbyweight(g)ofasolidinpartsbyvolume(ml)ofthefinalsolution;aspartsbyweight(g)ofagasinpartsbyweight(g)ofthefinalsolution.当溶液浓度以“溶质份数/溶液份数”表示时，固体溶质指每毫升最终溶液中含该固体的克数；气体溶质指每克最终溶液中含该气体的克数。WhentheconcentrationofasolutionisexpressedinmolaritydesignatedbythesymbolMprecededbyanumber,itdenotesthenumberofmolesofthestatedsolutecontainedinsufficientPurifiedWater(unlessotherwisestated)toproduce1litreofsolution.当溶液浓度以摩尔浓度（符号M前加数字表示）表示时，指每升溶液（除非另有说明，溶剂为纯化水）中含规定溶质的摩尔数。AbbreviatedStatementsIncompletesentencesareemployedinpartsofthemonographsfordirectnessandbrevity(forexample,IodineValue.Notmorethan;RelativeDensity.........to)Wherethetestsareabbreviated,itistobeunderstoodthatthetestmethodreferredtoinbracketsprovidesthemethodtobefollowedandthatthevaluesspecifiedaretheapplicablelimits.简要说明为简洁明了，正文部分内容采用省略句形式（例如：碘值不得过；相对密度为～）。试验项目采用省略表述时，应理解为括号中提及的试验方法为应遵循的方法，规定数值为适用限度。WeightsandMeasuresThemetricsystemofweightsandmeasuresisemployedinthePharmacopoeia.Allmeasuresarerequiredtobegraduatedat25°andallmeasurementsintestsandassays,unlessotherwisestated,aretobemadeatthattemperature.GraduatedglassapparatususedinanalyticaloperationsshallcomplywiththerequirementsstatedinChapter2.1.6.度量衡本药典采用公制计量单位。所有量器的刻度均以25℃为标准，除非另有说明，试验和测定中的所有测量操作均应在该温度下进行。分析操作中使用的玻璃量器应符合第2.1.6章的要求。Monographs各论GeneralMonographsGeneralmonographsondosageformsincluderequirementsofgeneralapplicationandapplytoallpreparationswithinthescopeoftheIntroductionsectionofthegeneralmonograph,exceptwhereapreamblelimitstheapplication.Therequirementsarenotnecessarilycomprehensiveforagivenspecificpreparation;additionalrequirementsmaysometimesbegivenintheindividualmonographforit.对于某一特定制剂，通则的要求未必全面，具体正文可能会增加额外要求。ProductionStatementsgivenundertheheadingProductionrelatetoparticularaspectsofthemanufacturingprocessandarenotnecessarilycomprehensive.However,theyaremandatoryinstructionstomanufacturers.Theymayrelate,forexample,tosourcematerials,tothemanufacturingprocessanditsvalidationandcontrol,toanyin-processtestingthatistobecarriedoutbythemanufactureronthefinalproducteitheronselectedbatchesoroneachbatchpriortorelease.Allthiscannotbeverifiedonasampleofthefinalproductbyanindependentanalyst.Itisforthelicensingauthoritytoverifythattheinstructionshavebeenfollowed.TheabsenceofasectiononProductiondoesnotimplythatattentiontofeaturessuchasthosegivenaboveisnotrequired.AnarticledescribedinamonographofthePharmacopoeiaistobemanufacturedinaccordancewiththeprinciplesofgoodmanufacturingpracticeandinaccordancewiththerequirementsoftheDrugsandCosmeticsRules,1945.Thegeneralprinciplesapplicabletothemanufactureandqualityassuranceofdrugsandpreparationsmeantforhumanuseapplyequallytoveterinaryproductsaswell.“生产”项下的表述涉及生产工艺的特定方面，未必全面，但对制造商具有强制性。其内容可能包括原料要求、生产工艺及其验证与控制、制造商对成品进行的过程检验（包括选定批次或每批放行前检验）等。独立检验人员无法通过成品样品验证上述所有要求的执行情况，应由许可机构核实制造商是否遵循了相关规范原则及1945年《药品和化妆品规则》的要求进行生产。适用于人体用药及制剂生产和质量保证的一般原则，同样适用于兽药产品。ManufactureofDrugProductsTheopeningdefinitivestatementincertainmonographsfordrugproductsisgivenintermsoftheactiveingredient(s)only.Anyingredient(s)otherthanthoseincludedinthestatement,mustcomplywiththegeneralnoticeonExcipientsandtheproductmustconformtothePharmacopoeialrequirements.药品生产部分药物制剂正文的开篇明确表述仅提及原料药。除该表述中所列成分外，其他任何成分均需符合辅料相关凡例要求，且该产品需符合药典各项规定。Officialpreparationsarepreparedonlyfromingredientsthatcomplywiththerequirementsofthepharmacopoeialmonographsforthoseindividualingredientsforwhichmonographsareprovided.法定制剂仅能采用符合药典正文要求的原料（对于有正文收载的原料）制备。ExcipientsAnysubstanceaddedinpreparinganofficialpreparationshallbeinnocuous,shallhavenoadverseinfluenceinthetherapeuticefficacyoftheactiveingredientsandshallnotinterferewiththetestsandassaysofthePharmacopoeia.Careshouldbetakentoensurethatsuchsubstancesarefreefromharmfulorganisms.制备法定制剂时添加的任何物质均应无毒害，不得对原料药的治疗效果产生不利影响，且不得干扰药典规定的试验和测定。应注意确保此类物质不含有害微生物。IndividualMonographs各论Drugproductsthatarethesubjectofanindividualmonographarealsorequiredtocomplywiththetestsgiveninthegeneralmonographs.具体正文收载的药物制剂，还需符合通则中规定的试验要求。TitlesThemaintitleforadrugsubstanceistheInternationalNon-proprietaryName(INN)approvedbytheWorldHealthOrganization.Subsidiarynamesandsynonymshavealsobeengiveninsomecases;whereincluded,theyhavethesamesignificanceasthemaintitle.标题原料药的主要名称为世界卫生组织批准的国际非专利名称（INN）。部分原料药还列出了副名和同义词，其含义与主要名称一致。Themaintitlesofdrugproductsaretheonescommonlyrecognisedinpractice.Synonymsdrawnfromthefullnon-proprietarynameoftheactiveingredientoringredientshavealsobeengiven.Where,however,aproductcontainsoneortheotherofdifferentsaltsofanactivemolecule,themaintitleisbasedonthefullnameoftheactiveingredient.Forexample,ChloroquinePhosphateTabletsandChloroquineSulphateTablets.药物制剂的主要名称为实际应用中普遍认可的名称，同时列出了源于原料药完整非专利名称的同义词。但若某产品含同一活性分子的不同盐类，则主要名称基于原料药的完整名称确定（例如：磷酸氯喹片、硫酸氯喹片）。ChemicalFormulaeWhenthechemicalstructureofanofficialsubstanceisknownorgenerallyaccepted,thegraphicandmolecularformulaearenormallygivenatthebeginningofthemonographforinformation.Thisinformationreferstothechemicallypuresubstanceandisnottoberegardedasanindicationofthepurityoftheofficialmaterial.化学式当法定物质的化学结构已知或被普遍认可时，正文开头通常会列出其结构式和分子式，供参考。该信息针对化学纯物质，不得视为对法定物质纯度的说明。Elsewhere,instatementofpurityandstrengthandindescriptionsofprocessesofassay,itwillbeevidentfromthecontextthattheformulaedenotethechemicallypuresubstances.Wheretheabsolutestereochemicalconfigurationisspecified,theInternationalUnionofPureandAppliedChemistry(IUPAC)R/SandE/Zsystemsofdesignationhavebeenused.在纯度与效价表述及含量测定方法描述等其他部分，结合上下文可知，所列分子式均指化学纯物质。若规定了绝对立体化学构型，则采用国际纯粹与应用化学联合会（IUPAC）的R/S及E/Z构型标记系统。Ifthesubstanceisanenantiomerofunknownabsolutestereochemistry,thesignoftheopticalrotation,asdeterminedinthesolventandundertheconditionsspecifiedinthemonograph,hasbeenattachedtothesystematicname.AnindicationofsignofrotationhasalsobeengivenwherethisisincorporatedinatrivialnamethatappearsonanIUPACpreferredlist.若该物质为绝对立体化学构型未知的对映体，则在系统名称后附上其在正文规定的溶剂和条件下测得的比旋光度符号。若IUPAC优选名称列表中的俗名已包含旋光度符号，则同样予以标注。AtomicandMolecularWeightsTheatomicweightormolecularweightisshown,asandwhenappropriateatthetoprighthandcomerofthemonograph.Theatomicandmolecularweightsandgraphicformulaedonotconstituteanalyticalstandardsforthesubstancesdescribed.原子量或分子量原子量或分子量（如适用）标注在正文右上角。原子量、分子量及结构式均不构成所述物质的分析标准。DefinitionTheopeningstatementofamonographisonethatconstitutesanofficialdefinitionofthesubstance,preparationorotherarticlethatisthesubjectofthemonograph.Incertainmonographsforpharmaceuticalpreparationsthestatementisgivenintermsoftheprincipalingredient(s).正文开篇表述为该正文所收载物质、制剂或其他物品的法定定义。部分药物制剂正文的开篇表述以主要成分为核心。Inmonographsonvegetabledrugs,thedefinitionindicateswhetherthesubjectofthemonographis,forexample,thewholedrugorthedruginpowderedform.Certainpharmaceuticalsubstancesandotherarticlesaredefinedbyreferencetoaparticularmethodofmanufacture.植物药正文的定义会明确该正文收载的是原药材还是粉末药材等。部分药物物质及其他物品的定义会涉及特定生产方法。Astatementthatasubstanceorarticleispreparedorobtainedbyacertainmethodconstitutespartoftheofficialdefinitionandimpliesthatothermethodsarenotpermitted.Astatementthatasubstancemaybepreparedorobtainedbyacertainmethod,however,indicatesthatthisisonepossiblemethodanddoesnotimplythatothermethodsarenotpermissible.若表述为“某物质或物品通过某方法制备或获得”法。若表述为“某物质可通过某方法制备或获得”，则该方法仅为可行方法之一，不排除其他方法的适用性。StatementofcontentThelimitsofcontentstatedarethosedeterminedbythemethoddescribedunderAssay.含量说明所述含量限度为采用“含量测定”项下方法测得的结果限度。CategoryThestatementofcategoryisprovidedforgeneralinformationonlyandisindicativeofthemedicalorpharmaceuticalbasisforrecognitioninthePharmacopoeia.Itgenerallyrepresentsanapplicationofthebestknownpharmacologicalactionofthearticleorofitsactiveingredient.Thestatementundertheheading‘Category’arealsosubjecttoregulationsundertheD&CAct1940andrulesthereunder.Inthecaseofpharmaceuticalaidsitmayindicatethemorecommonusageofthearticle.Thestatementisnotintendedtolimitinanywaythechoiceoruseofthearticlenortoindicatethatithasnootheractivityoruse.“类别”项下的表述仅为通用信息，表明该药品被药典收载的医学或药学依据。其通常反映该药品或其“类别”项下的表述还需符合1940（D&CAct1940）及其相关规则的规定。对于药用辅料，“类别”项可能标注其较常见的用途。该表述并非旨在以任何方式限制该药品的选择或使用，也不意味着该药品无其他活性或用途。UsualstrengthThestatementontheusualstrength(s)ofapreparationgivenintheindividualmonographindicatesthestrength(s)usuallymarketedforinformationofthepharmacistandthemedicalpractitioner.Itdoesnotimplythatastrengthotherthantheone(s)mentionedintheindividualmonographmeetingalltheprescribedrequirementscannotbemanufacturedandmarketedwiththeapprovaloftheappropriateauthority.常用规格具体正文中“常用规格”项下的表述，列出了该制剂通常上市销售的规格，供药师和医师参考。但这并不意味着，经相关机构批准，不得生产和销售其他符合所有规定要求的规格（非具体正文所列规格）。DescriptionThestatementsundertheheadingDescriptionarenottobeinterpretedinastrictsenseandarenottoberegardedasofficialrequirements.“性状”项下的表述不应作严格字面解读，且不视为法定要求。SolubilityStatementsonsolubilityaregiveninChapter2.4.26andareintendedasinformationontheapproximatesolubilityatatemperaturebetween15°and30°,unlessotherwisestated,andarenottobeconsideredasofficialrequirements.However,atestforsolubilitystatedinamonographconstitutespartofthestandardsforthesubstancethatisthesubjectofthatmonograph.溶解度相关表述见第2.4.26章，除非另有说明，均指15℃~30℃范围内的近似溶解度，仅供参考，不视为法定要求。但若正文中标注了溶解度试验，则该试验为该物质法定标准的一部分。ResidualsolventsTherequirements,guidanceandinformationonresidualsolventsforpharmaceuticalusearegiveninthechapterentitledResidualSolvents(5.4).残留溶剂药用残留溶剂的要求、指导原则及相关信息见“残留溶剂”（第5.4章）。AllIParticlesaresubjecttorelevantcontrolofresidualsolvents,evenwhennotestisspecifiedintheindividualmonograph.Ifsolventsareusedduringproduction,theymustbeofsuitablequality.Inaddition,thetoxicityandresiduallevelofeachsolventshallbetakenintoconsiderationandthesolventslimitedaccordingtotheprinciplesdefinedandtherequirementsspecifiedinChapter5.4.ResidualSolvent,usingthegeneralmethodspresentedthereinorothersuitablemethods.所有印度药典收载药品均需符合残留溶剂相关控制要求，即使具体正文未规定残留溶剂试验。若生产过程中使用溶剂，该溶剂需符合适宜质量要求。此外，需考虑每种溶剂的毒性及残留水平，并根据第5.4章“残留溶剂”中规定的原则和要求，采用该章所述通用方法或其他适宜方法控制溶剂残留限度。TestMethods测试方法Referencestogeneralmethodsoftestingareindicatedbytestmethodnumbersinbracketsimmediatelyaftertheheadingofthetestorattheendofthetext.通用试验方法的引用，以试验项目标题后或文本末尾括号内的试验方法编号表示。IdentificationThetestsgivenundertheheadingIdentificationarenotnecessarilysufficienttoestablishabsoluteproofofidentity.Theyprovideameansofverifyingthattheidentityofthematerialunderexaminationisinaccordancewiththelabelonthecontainer.“鉴别”项下的试验并非一定能构成对药品身份的绝对证明。其仅用于核实供试品身份与容器标签标注一致。Incertainmonographsalternativeseriesofidentificationtestsaregiven;compliancewitheitheroneortheothersetoftestsisadequatetoverifytheidentityofthearticle.部分正文列出了多组备选鉴别试验，符合其中任意一组试验要求，即可视为通过鉴别。Whentestsforinfraredabsorptionareappliedtomaterialextractedfromformulatedpreparations,strictconcordancewiththespecifiedreferencespectrummaynotalwaysbepossible,butneverthelessacloseresemblancebetweenthespectrumoftheextractedmaterialandthespecifiedreferencespectrumshouldbeachieved.当对制剂中提取的物质进行红外吸收试验时，其光谱未必能与规定的对照光谱完全一致，但提取物质的光谱应与规定对照光谱高度相似。TestsandAssays试验和测定ThetestsandassaysaretheofficialmethodsuponwhichthestandardsofthePharmacopoeiadepend.Therequirementsarenotframedtotakeintoaccountallpossibleimpurities.Itisnottobepresumed,forexample,thatanimpuritythatisnotdetectablebymeansoftheprescribedtestsistolerated.Materialfoundtocontainsuchanimpurityisnotofpharmacopoeialqualityifthenatureoramountoftheimpurityfoundisincompatiblewithgoodpharmaceuticalpractice.试验和测定方法为法定方法，是药典标准的依据。相关要求并非为考虑所有可能的杂质而制定。例如，不得默认规定试验无法检出的杂质即为允许存在的杂质。若供试品中发现的杂质性质或含量不符合药品生产质量管理规范要求，则该供试品不符合药典质量要求。Pharmacopoeialmethodsandlimitsshouldbeusedmerelyascompliancerequirementsandnotasrequirementstoguaranteetotalqualityassurance.Testsandassaysareprescribedfortheminimumsampleavailableonwhichtheattributesofthearticleshouldbemeasured.Assuranceofqualitymustbeensuredbythemanufacturerbytheuseofstatisticallyvalidsamplingandtestingprogrammes.药典方法与限度仅应作为合规性要求，而非保障全面质量保证的要求。检查与测定法针对可供使用的最小样品制定，用于测定该药品的各项属性。生产商必须通过采用统计学有效的取样及检验方案，确保质量保证。TestsUnlessotherwisestated,theassaysandtestsarecarriedoutatatemperaturebetween20°and30°.除非另有说明，测定和试验均在20℃~30℃下进行。Whereitisdirectedthatananalyticaloperationistobecarriedout‘insubduedlight’,precautionsshouldbetakentoavoidexposuretodirectsunlightorotherstronglight.Whereaprocedureisdirectedtobeperformed‘protectedfromlight’precautionsshouldbetakentoexcludeactiniclightbytheuseoflow-actinicglassware,workinginadarkroomorsimilarprocedures.若要求分析操作在“弱光下”进行，应采取预防措施，避免暴露于直射阳光或其他强光下。若要求操作“避光”进行，应采用低透光率玻璃器皿、在暗室中操作或其他类似方法，避免光化射线照射。Forpreparationsotherthanthoseoffixedstrength,thequantitytobetakenforatestoranassayisusuallyexpressedintermsoftheactiveingredient.Thismeansthatthequantityof