本文件由AI本文件由AI進(jìn)行翻譯，僅供行業(yè)交流使用，譯文準(zhǔn)確性不做最終負(fù)責(zé)，僅供參考GENERALNOTICES凡例JP2022GeneralStatements總則TheGeneralNoticesprovidethebasicguidelinesfortheinterpretationandapplicationofthestandards,tests,assays,andotherspecificationsoftheIndianPharmacopoeia(IP),aswellastothestatementsmadeinthemonographsandothertextsofthePharmacopoeia.凡例為印度藥典（IP）標(biāo)準(zhǔn)、試驗(yàn)、測(cè)定及其他規(guī)格要求的解釋與應(yīng)用，以及藥典正文中的各項(xiàng)表述和其他文本內(nèi)容，提供基本指導(dǎo)原則。Amonographistobeconstructedinaccordancewithanygeneralmonographornoticeoranyappendix,noteorotherexplanatorymaterialthatiscontainedinthisPharmacopoeiaandthatisapplicabletothatmonograph.Allstatementscontainedinthemonograph,exceptwhereaspecificgeneralnoticeindicatesotherwiseandwiththeexceptionsgivenhereafter,constitutestandardsfortheofficialarticles.Anarticleisnotofpharmacopoeialqualityunlessitcomplieswithalloftherequirementsstated.正文的編寫應(yīng)符合本藥典中適用于該正文的通則、凡例、附錄、注釋或其他解釋性內(nèi)容的要求。除特定凡例另有說明及下文所列例外情況外，正文中的所有表述均構(gòu)成法定藥品的標(biāo)準(zhǔn)。藥品必須符合所有規(guī)定要求，方可視為符合藥典級(jí)質(zhì)量。ExceptionstotheGeneralNoticesdoexist,andwheretheydo,thewordingintheindividualmonographoranappendixtakesprecedenceandspecificallyindicatesdirectionsortheintent.Thus,thespecificwordingofstandards,tests,assaysandotherspecificationsisbindingwhereverdeviationsfromtheGeneralNoticesexist.Likewise,wherethereisnospecificmentiontothecontrary,theGeneralNoticesapply.凡例存在例外情況，當(dāng)出現(xiàn)例外時(shí)，以具體正文或附錄中的表述為準(zhǔn)，該表述將明確說明相關(guān)要求或意圖。因此，凡與凡例不一致之處，標(biāo)準(zhǔn)、試驗(yàn)、測(cè)定及其他規(guī)格要求的具體表述具有約束力；同理，無特殊相反說明時(shí)，凡例均適用。NameThefullnameortitleofthisbook,includingaddendathereto,isIndianPharmacopoeia2022,abbreviatedtoIP2022.Inthetexts,theterm“Pharmacopoeia”or“IP”withoutqualificationmeanstheIndianPharmacopoeia2022andanyamendmentsthereto.名字本書全稱（含增補(bǔ)本）為《印度藥典2022年版》，縮寫為IP2022。正文中未特別限定的“藥典”或“IP”一詞，均指《印度藥典2022年版》及其任何修訂版。OfficialandOfficialArticlesTheword‘official’whereverusedinthisPharmacopoeiaorwithreferencethereto,issynonymouswith‘pharmacopoeial’,with‘IP’andwith‘compendial’.ThedesignationIPinconjunctionwiththeofficialtitleonthelabelofanarticleisanindicationthatthearticlepurportstocomplywithIPstandards.法定藥品及法定藥品條目本藥典中凡使用“法定”一詞，或涉及該表述時(shí)，均與“藥典級(jí)”“IP”及“藥典收載”同義。藥品標(biāo)簽上標(biāo)注的法定名稱旁附有“IP”標(biāo)識(shí)，表明該藥品聲稱符合印度藥典標(biāo)準(zhǔn)。Thefollowingtermsareusedwherethearticlesforwhichmonographsareprovidedaretobedistinguished.Anofficialsubstanceisasingledrugoradrugentityorapharmaceuticalaidforwhichthemonographtitleincludesnoindicationofthenatureofadosageform.Anofficialpreparationisadrugproduct(dosageform)andisthefinishedorpartiallyfinishedpreparationorproductofoneormoreofficialsubstancesformulatedforuseonthepatient.Anarticleisanitemforwhichamonographisprovided,whetheranofficialsubstanceoranofficialpreparation.對(duì)于藥典正文收載的各類藥品，采用以下術(shù)語加以區(qū)分：法定物質(zhì)指單一藥物、藥物實(shí)體或藥用輔料，其正文標(biāo)題中未注明劑型屬性；法定制劑指藥物制品（劑型），是由一種或多種法定物質(zhì)配制而成、供患者使用的成品或半成品制劑；藥品指正文收載的各類物品，包括法定物質(zhì)和法定制劑。OfficialStandardsTherequirementsstatedinthemonographsapplytoarticlesthatareintendedformedicinalusebutnotnecessarilytoarticlesthatmaybesoldunderthesamenameforotherpurposes.法定標(biāo)準(zhǔn)正文中的要求適用于藥用藥品，對(duì)于以相同名稱銷售但用于其他用途的物品，不一定適用。AnarticleisnotofPharmacopoeialqualityunlessitcomplieswithalltherequirementsstatedinthemonograph.ThisdoesnotimplythatperformanceofallthetestsinamonographisnecessarilyaprerequisiteforamanufacturerinassessingcompliancewiththePharmacopoeiabeforereleaseofaproduct.除非某藥品符合各論中規(guī)定的所有要求，否則該藥品即不屬于藥典質(zhì)量。但這并不意味著生產(chǎn)商在產(chǎn)品放行前評(píng)估其是否符合藥典要求時(shí)，必須執(zhí)行各論中的所有測(cè)試。Pharmacopoeialrequirementsforarticlesusedinveterinarymedicineareestablishedonthesamebasisasthoseusedinhumanmedicine.Itshouldbenotedthatnorequirementinthepharmacopoeiacanbetakeninisolation.Avalidinterpretationofanyparticularrequirementdependsuponitbeingreadincontextofthemonographasawhole,thespecifiedmethodofanalysis,therelevantGeneralNoticesandwhereappropriatetheGeneralMonographs.獸藥的藥典要求與人體用藥的藥典要求基于相同原則制定。需注意，藥典中的任何要求均不可孤立解讀。對(duì)任一特定要求的有效解讀，均需結(jié)合完整各論、規(guī)定的分析方法、相關(guān)凡例及（如適用）通則進(jìn)行。WhereapreparationthatisthesubjectofamonographintheIndianPharmacopoeiaissuppliedforuseinveterinarymedicine,thestandardsofIndianPharmacopoeiaapplyunlessotherwisejustifiedandauthorized.若印度藥典正文收載的制劑供獸醫(yī)使用，除非有正當(dāng)理由并經(jīng)批準(zhǔn)，否則應(yīng)符合印度藥典標(biāo)準(zhǔn)。Theactivepharmaceuticalingredients(drugsubstances),excipients(pharmaceuticalaids),pharmaceuticalpreparations(dosageforms)andotherarticlesdescribedinthemonographsareintendedforhumanandveterinaryuse(unlessexplicitlyrestrictedtooneoftheseuses).Itmaybenoted,however,thatintheeventofdoubtofinterpretationinanytextofVeterinarymonographsofIP,IndianPharmacopoeiaCommission(IPC)shouldbeconsulted.正文中描述的原料藥、輔料（藥用輔料）、藥物制劑（劑型）及其他物品，均適用于人體和獸醫(yī)使用（除非明確限定僅適用于其中一種用途）。但需注意，若對(duì)印度藥典獸醫(yī)正文的任何內(nèi)容解讀存在疑問，應(yīng)咨詢印度藥典委員會(huì)（IPC）。Therequirementsgiveninthemonographsarenotframedtoprovideagainstallpossibleimpurities,contaminantsoradulterants;theyprovideappropriatelimitationofpotentialimpuritiesonly.正文中的要求并非為防范所有可能的雜質(zhì)、污染物或摻雜物而制定，僅對(duì)潛在雜質(zhì)規(guī)定了適當(dāng)限度。Apreparationmustcomplywiththerequirementsspecified,throughoutitsshelf-lifeassignedtoitbythemanufacturer.Foropenedorbroachedcontainers,themaximumperiodofvalidityforusewillbeasmaybestatedintheindividualmonograph.Nevertheless,theresponsibilityforassigningtheperiodofvalidityshallbewiththemanufacturer.制劑必須在生產(chǎn)商規(guī)定的整個(gè)有效期內(nèi)符合規(guī)定的要求。對(duì)于已開啟或已開封的容器裝制劑，其最長使用有效期應(yīng)按照各論中的規(guī)定執(zhí)行。不過，確定有效期的責(zé)任應(yīng)由生產(chǎn)商承擔(dān)。AddedSubstancesAnofficialsubstance,asdistinguishedfromanofficialpreparation,containsnoaddedsubstancesexceptwhenspecificallypermittedintheindividualmonograph.Unlessotherwisespecifiedintheindividualmonograph,orelsewhereintheGeneralNotices,suitablesubstancesmaybeaddedtoanofficialpreparationtoenhanceitsstability,preserveitsproperties,usefulnessorelegance,ortofacilitateitspreparation.Suchauxiliarysubstancesshallbeharmlessintheamountsused,shallnotexceedtheminimumquantityrequiredtoprovidetheirintendedeffect,shallnotimpairthetherapeuticefficacyorthebioavailabilityorsafetyofthepreparationandshallnotinterferewithanyofthetestsandassaysprescribedfordeterminingcompliancewiththeofficialstandards.Particularcareshouldbetakentoensurethatsuchsubstancesarefreefromharmfulorganisms.Thefreedomtothemanufacturerstoaddauxiliarysubstancesimposesonthemtheresponsibilityofsatisfyingthelicensingauthoritiesonthepurposeoftheadditionandtheinnocuityofsuchsubstances.Nosubstanceshallbeaddedtoconcealanydefectordamageordeficiencyinthesubstanceorformulation.外加物質(zhì)與法定制劑不同，法定物質(zhì)不得添加任何物質(zhì)，除非具體正文明確允許。除非具體正文或凡例其他部分另有規(guī)定，可在法定制劑中添加適宜物質(zhì)，以增強(qiáng)其穩(wěn)定性、保持其特性、實(shí)用性或外觀，或便于制劑制備。此類輔助物質(zhì)在使用劑量下應(yīng)無毒害，用量不得超過實(shí)現(xiàn)其預(yù)期效果所需的最低量，不得降低制劑的治療效果、生物利用度或安全性，且不得干擾為判定是否符合法定標(biāo)準(zhǔn)而規(guī)定的任何試驗(yàn)和測(cè)定。應(yīng)特別注意確保此類物質(zhì)不含有害微生物。制造商有權(quán)添加輔助物質(zhì)，但需向許可機(jī)構(gòu)說明添加目的及該物質(zhì)的無害性，并對(duì)此承擔(dān)責(zé)任。不得添加任何物質(zhì)以掩蓋該物質(zhì)或制劑中的缺陷、損壞或不足。AlternativeMethodsThetestsandassaysdescribedaretheofficialmethodsuponwhichthestandardsofthePharmacopoeiaarebased.Alternativemethodsofanalysismaybeusedforcontrolpurposes,providedthatthemethodsusedareshowntogiveresultsofequivalentaccuracyandenableanunequivocaldecisiontobemadeastowhethercompliancewiththestandardsofthemonographswouldbeachievediftheofficialmethodswereused.Automatedproceduresutilisingthesamebasicchemistryasthetestproceduresgiveninthemonographmayalsobeusedtodeterminecompliance.Suchalternativeorautomatedproceduresmustbevalidatedandaresubjecttoapprovalbytheauthoritycompetenttoauthorizemanufacturerofsubstanceorproduct.替代方法所述試驗(yàn)和測(cè)定方法為法定方法，是藥典標(biāo)準(zhǔn)的依據(jù)?？刹捎锰娲治龇椒ㄟM(jìn)行質(zhì)量控制，但需證明該方法所得結(jié)果的準(zhǔn)確性與法定方法相當(dāng)，且能明確判定若采用法定方法時(shí)該藥品是否符合正文標(biāo)準(zhǔn)。采用與正文試驗(yàn)方法基本化學(xué)原理一致的自動(dòng)化流程，也可用于判定是否符合標(biāo)準(zhǔn)。此類替代方法或自動(dòng)化流程必須經(jīng)過驗(yàn)證，并經(jīng)有權(quán)批準(zhǔn)該物質(zhì)或產(chǎn)品制造商的機(jī)構(gòu)批準(zhǔn)。Intheeventofdoubtordispute,themethodsofanalysisofthePharmacopoeiaarealoneauthoritativeandonlytheresultobtainedbytheproceduregiveninthisPharmacopoeiaisconclusive.若存在疑問或爭(zhēng)議，僅藥典規(guī)定的分析方法具有權(quán)威性，且只有通過本藥典規(guī)定流程獲得的結(jié)果才具有決定性。MeaningsofTerms術(shù)語含義AlcoholTheterm“alcohol”withoutqualificationmeansethanol(95percent).Otherdilutionsofethanolareindicatedbytheterm“ethanol”or“alcohol”followedbyastatementofthepercentagebyvolumeofethanol(C?H?O)required.注明所需乙醇（C?H?O）的體積百分比。DesiccatorAtightly-closedcontainerofsuitablesizeanddesignthatmaintainsanatmosphereoflowmoisturecontentbymeansofsilicagelorphosphoruspentoxideorothersuitabledesiccant.干燥器指密封性良好、尺寸和設(shè)計(jì)適宜的容器，通過硅膠、五氧化二磷或其他適宜干燥劑維持低濕度環(huán)境。DryingandignitiontoconstantweightTwoconsecutiveweighingsafterthedryingorignitingoperationsdonotdifferbymorethan0.5mg,thesecondweighingfollowinganadditionalperiodofdryingorofignitionrespectivelyappropriatetothenatureandquantityoftheresidue.干燥并熾灼至恒重指干燥或熾灼操作后，連續(xù)兩次稱量的差值不超過0.5毫克，第二次稱量需在根據(jù)殘?jiān)再|(zhì)和數(shù)量確定的額外干燥或熾灼時(shí)間后進(jìn)行。EthanolTheterm“ethanol”withoutqualificationmeansanhydrousethanolorabsolutealcohol.“乙醇”（ethanol）一詞未特別限定狀態(tài)時(shí)，指無水乙醇。FiltrationUnlessotherwisestated,filtrationisthepassingofaliquidthroughasuitablefilterpaperorequivalentdeviceuntilthefiltrateisclear.除非另有說明，過濾指將液體通過適宜濾紙或等效裝置，直至濾液澄清。FreshlypreparedMadenotmorethan24hoursbeforeitisused.指使用前24小時(shí)內(nèi)制備。LabelAnyprintedpackingmaterial,includingpackageinsertsthatprovideinformationonthearticle.指任何印有藥品相關(guān)信息的包裝材料，包括說明書。NegligibleAquantitynotexceeding0.50mg.指不超過0.50毫克的量。SolutionWherethenameofthesolventisnotstated,“solution”impliesasolutioninwater.ThewaterusedcomplieswiththerequirementsofthemonographonPurifiedWater.未注明溶劑名稱時(shí)，“溶液”指水溶液。所用水分需符合“純化水”正文的要求。TemperatureThesymbol°usedwithoutqualificationindicatestheuseoftheCelsiusthermometricscale.未特別限定的溫度符號(hào)“°”指攝氏溫度。WaterIfthetermisusedwithoutqualificationitmeansPurifiedWaterofthePharmacopoeia.Theterm‘distilledwater’indicatesPurifiedWaterpreparedbydistillation.“水”一詞未特別限定類型時(shí)，指本藥典中的純化水?！罢麴s水”指通過蒸餾法制備的純化水。Water-bathAbathofboilingwaterunlesswateratanothertemperatureisindicated.Othermethodsofheatingmaybeusedprovidedtherequiredtemperatureisapproximatelymaintainedbutnotexceeded.指沸水浴，除非注明其他溫度?？刹捎闷渌訜岱绞剑璐笾戮S持所需溫度且不超過該溫度。ProvisionsApplicableToMonographsandTestMethods適用于各論和檢驗(yàn)方法的規(guī)定ExpressionofContentsWherethecontentofasubstanceisdefined,theexpression“percent”isusedaccordingtocircumstanceswithoneoftwomeanings:當(dāng)規(guī)定某物質(zhì)的含量時(shí)，“百分比”（percent）根據(jù)情況具有以下兩種含義之一：percentw/w(percentage,weightinweight)expressingthenumberofgramsofsubstancein100gramsoffinalproduct,重量百分比（w/w）指每100克最終產(chǎn)品中含該物質(zhì)的克數(shù)；percentv/v(percentage,volumeinvolume)expressingthenumberofmillilitresofsubstancein100millilitresoffinalproduct.體積百分比（v/v）指每100毫升最終產(chǎn)品中含該物質(zhì)的毫升數(shù)。Theexpression“partspermillion”referstotheweightinweight,unlessotherwisestated.“百萬分之”（partspermillion）除非另有說明，均指重量百分比。Wherethecontentofasubstanceisexpressedintermsofthechemicalformulaforthatsubstanceanupperlimitexceeding100percentmaybestated.Suchanupperlimitappliestotheresultoftheassaycalculatedintermsoftheequivalentcontentofthespecifiedchemicalformula.Forexample,thestatement‘containsnotlessthan99.0percentandnotmorethan101.0percentofC?H?O?impliesthattheresultoftheassayisnotlessthan99.0percentandnotmorethan101.0percent,calculatedintermsoftheequivalentcontentofC?H?O?.當(dāng)某物質(zhì)的含量以其化學(xué)式表示時(shí)，允許規(guī)定超過100%的上限。該上限適用于以規(guī)定化學(xué)式的等效含量計(jì)算得出的含量測(cè)定結(jié)果。例如，“含C?H?O?不得少于99.0%，且不得超過101.0%”，指以C?H?O?的等效含量計(jì)算，含量測(cè)定結(jié)果應(yīng)在99.0%~101.0%之間。Wheretheresultofanassayortestisrequiredtobecalculatedwithreferencetothedried,anhydrous,ignitedsubstance,orthesubstancefreefromsolvent,thedeterminationoflossondrying,watercontent,lossonignition,contentofthespecifiedsolvent,respectivelyiscarriedoutbythemethodprescribedintherelevanttestinthemonograph.若含量測(cè)定或試驗(yàn)結(jié)果需以干燥品、無水物、熾灼殘?jiān)驘o溶劑物為基準(zhǔn)計(jì)算，則需分別采用正文相關(guān)試驗(yàn)中規(guī)定的方法測(cè)定干燥失重、水分、熾灼失重或規(guī)定溶劑的含量。ExpressionofConcentrationsThefollowingexpressionsinadditiontotheonesgivenunderExpressionofContentarealsoused:除含量表示方法外，還使用以下濃度表示方法：percentw/v(percentage,weightinvolume)expressingthenumberofgramsofsubstancein100millilitresofproduct,重量體積百分比（w/v）指每100毫升產(chǎn)品中含該物質(zhì)的克數(shù)；percentv/w(percentage,volumeinweight)expressingthenumberofmillilitresofsubstancein100gramsofproduct.體積重量百分比（v/w）指每100克產(chǎn)品中含該物質(zhì)的毫升數(shù)。Usually,thestrengthofsolutionsofsolidsinliquidsisexpressedaspercentageweightinvolume,ofliquidsinliquidsaspercentagevolumeinvolume,ofsolidsinsemi-solidbases(e.g.creams)andofgasesinliquidsaspercentageweightinweight.通常，固體在液體中的溶液濃度以重量體積百分比表示，液體在液體中的溶液濃度以體積百分比表示，固體在半固體基質(zhì)（如乳膏）中的濃度及氣體在液體中的濃度以重量百分比表示。Whentheconcentrationofasolutionisexpressedaspartsofdissolvedsubstanceinpartsofsolution,itmeanspartsbyweight(g)ofasolidinpartsbyvolume(ml)ofthefinalsolution;aspartsbyweight(g)ofagasinpartsbyweight(g)ofthefinalsolution.當(dāng)溶液濃度以“溶質(zhì)份數(shù)/溶液份數(shù)”表示時(shí)，固體溶質(zhì)指每毫升最終溶液中含該固體的克數(shù)；氣體溶質(zhì)指每克最終溶液中含該氣體的克數(shù)。WhentheconcentrationofasolutionisexpressedinmolaritydesignatedbythesymbolMprecededbyanumber,itdenotesthenumberofmolesofthestatedsolutecontainedinsufficientPurifiedWater(unlessotherwisestated)toproduce1litreofsolution.當(dāng)溶液濃度以摩爾濃度（符號(hào)M前加數(shù)字表示）表示時(shí)，指每升溶液（除非另有說明，溶劑為純化水）中含規(guī)定溶質(zhì)的摩爾數(shù)。AbbreviatedStatementsIncompletesentencesareemployedinpartsofthemonographsfordirectnessandbrevity(forexample,IodineValue.Notmorethan;RelativeDensity.........to)Wherethetestsareabbreviated,itistobeunderstoodthatthetestmethodreferredtoinbracketsprovidesthemethodtobefollowedandthatthevaluesspecifiedaretheapplicablelimits.簡(jiǎn)要說明為簡(jiǎn)潔明了，正文部分內(nèi)容采用省略句形式（例如：碘值不得過；相對(duì)密度為～）。試驗(yàn)項(xiàng)目采用省略表述時(shí)，應(yīng)理解為括號(hào)中提及的試驗(yàn)方法為應(yīng)遵循的方法，規(guī)定數(shù)值為適用限度。WeightsandMeasuresThemetricsystemofweightsandmeasuresisemployedinthePharmacopoeia.Allmeasuresarerequiredtobegraduatedat25°andallmeasurementsintestsandassays,unlessotherwisestated,aretobemadeatthattemperature.GraduatedglassapparatususedinanalyticaloperationsshallcomplywiththerequirementsstatedinChapter2.1.6.度量衡本藥典采用公制計(jì)量單位。所有量器的刻度均以25℃為標(biāo)準(zhǔn)，除非另有說明，試驗(yàn)和測(cè)定中的所有測(cè)量操作均應(yīng)在該溫度下進(jìn)行。分析操作中使用的玻璃量器應(yīng)符合第2.1.6章的要求。Monographs各論GeneralMonographsGeneralmonographsondosageformsincluderequirementsofgeneralapplicationandapplytoallpreparationswithinthescopeoftheIntroductionsectionofthegeneralmonograph,exceptwhereapreamblelimitstheapplication.Therequirementsarenotnecessarilycomprehensiveforagivenspecificpreparation;additionalrequirementsmaysometimesbegivenintheindividualmonographforit.對(duì)于某一特定制劑，通則的要求未必全面，具體正文可能會(huì)增加額外要求。ProductionStatementsgivenundertheheadingProductionrelatetoparticularaspectsofthemanufacturingprocessandarenotnecessarilycomprehensive.However,theyaremandatoryinstructionstomanufacturers.Theymayrelate,forexample,tosourcematerials,tothemanufacturingprocessanditsvalidationandcontrol,toanyin-processtestingthatistobecarriedoutbythemanufactureronthefinalproducteitheronselectedbatchesoroneachbatchpriortorelease.Allthiscannotbeverifiedonasampleofthefinalproductbyanindependentanalyst.Itisforthelicensingauthoritytoverifythattheinstructionshavebeenfollowed.TheabsenceofasectiononProductiondoesnotimplythatattentiontofeaturessuchasthosegivenaboveisnotrequired.AnarticledescribedinamonographofthePharmacopoeiaistobemanufacturedinaccordancewiththeprinciplesofgoodmanufacturingpracticeandinaccordancewiththerequirementsoftheDrugsandCosmeticsRules,1945.Thegeneralprinciplesapplicabletothemanufactureandqualityassuranceofdrugsandpreparationsmeantforhumanuseapplyequallytoveterinaryproductsaswell.“生產(chǎn)”項(xiàng)下的表述涉及生產(chǎn)工藝的特定方面，未必全面，但對(duì)制造商具有強(qiáng)制性。其內(nèi)容可能包括原料要求、生產(chǎn)工藝及其驗(yàn)證與控制、制造商對(duì)成品進(jìn)行的過程檢驗(yàn)（包括選定批次或每批放行前檢驗(yàn)）等。獨(dú)立檢驗(yàn)人員無法通過成品樣品驗(yàn)證上述所有要求的執(zhí)行情況，應(yīng)由許可機(jī)構(gòu)核實(shí)制造商是否遵循了相關(guān)規(guī)范原則及1945年《藥品和化妝品規(guī)則》的要求進(jìn)行生產(chǎn)。適用于人體用藥及制劑生產(chǎn)和質(zhì)量保證的一般原則，同樣適用于獸藥產(chǎn)品。ManufactureofDrugProductsTheopeningdefinitivestatementincertainmonographsfordrugproductsisgivenintermsoftheactiveingredient(s)only.Anyingredient(s)otherthanthoseincludedinthestatement,mustcomplywiththegeneralnoticeonExcipientsandtheproductmustconformtothePharmacopoeialrequirements.藥品生產(chǎn)部分藥物制劑正文的開篇明確表述僅提及原料藥。除該表述中所列成分外，其他任何成分均需符合輔料相關(guān)凡例要求，且該產(chǎn)品需符合藥典各項(xiàng)規(guī)定。Officialpreparationsarepreparedonlyfromingredientsthatcomplywiththerequirementsofthepharmacopoeialmonographsforthoseindividualingredientsforwhichmonographsareprovided.法定制劑僅能采用符合藥典正文要求的原料（對(duì)于有正文收載的原料）制備。ExcipientsAnysubstanceaddedinpreparinganofficialpreparationshallbeinnocuous,shallhavenoadverseinfluenceinthetherapeuticefficacyoftheactiveingredientsandshallnotinterferewiththetestsandassaysofthePharmacopoeia.Careshouldbetakentoensurethatsuchsubstancesarefreefromharmfulorganisms.制備法定制劑時(shí)添加的任何物質(zhì)均應(yīng)無毒害，不得對(duì)原料藥的治療效果產(chǎn)生不利影響，且不得干擾藥典規(guī)定的試驗(yàn)和測(cè)定。應(yīng)注意確保此類物質(zhì)不含有害微生物。IndividualMonographs各論Drugproductsthatarethesubjectofanindividualmonographarealsorequiredtocomplywiththetestsgiveninthegeneralmonographs.具體正文收載的藥物制劑，還需符合通則中規(guī)定的試驗(yàn)要求。TitlesThemaintitleforadrugsubstanceistheInternationalNon-proprietaryName(INN)approvedbytheWorldHealthOrganization.Subsidiarynamesandsynonymshavealsobeengiveninsomecases;whereincluded,theyhavethesamesignificanceasthemaintitle.標(biāo)題原料藥的主要名稱為世界衛(wèi)生組織批準(zhǔn)的國際非專利名稱（INN）。部分原料藥還列出了副名和同義詞，其含義與主要名稱一致。Themaintitlesofdrugproductsaretheonescommonlyrecognisedinpractice.Synonymsdrawnfromthefullnon-proprietarynameoftheactiveingredientoringredientshavealsobeengiven.Where,however,aproductcontainsoneortheotherofdifferentsaltsofanactivemolecule,themaintitleisbasedonthefullnameoftheactiveingredient.Forexample,ChloroquinePhosphateTabletsandChloroquineSulphateTablets.藥物制劑的主要名稱為實(shí)際應(yīng)用中普遍認(rèn)可的名稱，同時(shí)列出了源于原料藥完整非專利名稱的同義詞。但若某產(chǎn)品含同一活性分子的不同鹽類，則主要名稱基于原料藥的完整名稱確定（例如：磷酸氯喹片、硫酸氯喹片）。ChemicalFormulaeWhenthechemicalstructureofanofficialsubstanceisknownorgenerallyaccepted,thegraphicandmolecularformulaearenormallygivenatthebeginningofthemonographforinformation.Thisinformationreferstothechemicallypuresubstanceandisnottoberegardedasanindicationofthepurityoftheofficialmaterial.化學(xué)式當(dāng)法定物質(zhì)的化學(xué)結(jié)構(gòu)已知或被普遍認(rèn)可時(shí)，正文開頭通常會(huì)列出其結(jié)構(gòu)式和分子式，供參考。該信息針對(duì)化學(xué)純物質(zhì)，不得視為對(duì)法定物質(zhì)純度的說明。Elsewhere,instatementofpurityandstrengthandindescriptionsofprocessesofassay,itwillbeevidentfromthecontextthattheformulaedenotethechemicallypuresubstances.Wheretheabsolutestereochemicalconfigurationisspecified,theInternationalUnionofPureandAppliedChemistry(IUPAC)R/SandE/Zsystemsofdesignationhavebeenused.在純度與效價(jià)表述及含量測(cè)定方法描述等其他部分，結(jié)合上下文可知，所列分子式均指化學(xué)純物質(zhì)。若規(guī)定了絕對(duì)立體化學(xué)構(gòu)型，則采用國際純粹與應(yīng)用化學(xué)聯(lián)合會(huì)（IUPAC）的R/S及E/Z構(gòu)型標(biāo)記系統(tǒng)。Ifthesubstanceisanenantiomerofunknownabsolutestereochemistry,thesignoftheopticalrotation,asdeterminedinthesolventandundertheconditionsspecifiedinthemonograph,hasbeenattachedtothesystematicname.AnindicationofsignofrotationhasalsobeengivenwherethisisincorporatedinatrivialnamethatappearsonanIUPACpreferredlist.若該物質(zhì)為絕對(duì)立體化學(xué)構(gòu)型未知的對(duì)映體，則在系統(tǒng)名稱后附上其在正文規(guī)定的溶劑和條件下測(cè)得的比旋光度符號(hào)。若IUPAC優(yōu)選名稱列表中的俗名已包含旋光度符號(hào)，則同樣予以標(biāo)注。AtomicandMolecularWeightsTheatomicweightormolecularweightisshown,asandwhenappropriateatthetoprighthandcomerofthemonograph.Theatomicandmolecularweightsandgraphicformulaedonotconstituteanalyticalstandardsforthesubstancesdescribed.原子量或分子量原子量或分子量（如適用）標(biāo)注在正文右上角。原子量、分子量及結(jié)構(gòu)式均不構(gòu)成所述物質(zhì)的分析標(biāo)準(zhǔn)。DefinitionTheopeningstatementofamonographisonethatconstitutesanofficialdefinitionofthesubstance,preparationorotherarticlethatisthesubjectofthemonograph.Incertainmonographsforpharmaceuticalpreparationsthestatementisgivenintermsoftheprincipalingredient(s).正文開篇表述為該正文所收載物質(zhì)、制劑或其他物品的法定定義。部分藥物制劑正文的開篇表述以主要成分為核心。Inmonographsonvegetabledrugs,thedefinitionindicateswhetherthesubjectofthemonographis,forexample,thewholedrugorthedruginpowderedform.Certainpharmaceuticalsubstancesandotherarticlesaredefinedbyreferencetoaparticularmethodofmanufacture.植物藥正文的定義會(huì)明確該正文收載的是原藥材還是粉末藥材等。部分藥物物質(zhì)及其他物品的定義會(huì)涉及特定生產(chǎn)方法。Astatementthatasubstanceorarticleispreparedorobtainedbyacertainmethodconstitutespartoftheofficialdefinitionandimpliesthatothermethodsarenotpermitted.Astatementthatasubstancemaybepreparedorobtainedbyacertainmethod,however,indicatesthatthisisonepossiblemethodanddoesnotimplythatothermethodsarenotpermissible.若表述為“某物質(zhì)或物品通過某方法制備或獲得”法。若表述為“某物質(zhì)可通過某方法制備或獲得”，則該方法僅為可行方法之一，不排除其他方法的適用性。StatementofcontentThelimitsofcontentstatedarethosedeterminedbythemethoddescribedunderAssay.含量說明所述含量限度為采用“含量測(cè)定”項(xiàng)下方法測(cè)得的結(jié)果限度。CategoryThestatementofcategoryisprovidedforgeneralinformationonlyandisindicativeofthemedicalorpharmaceuticalbasisforrecognitioninthePharmacopoeia.Itgenerallyrepresentsanapplicationofthebestknownpharmacologicalactionofthearticleorofitsactiveingredient.Thestatementundertheheading‘Category’arealsosubjecttoregulationsundertheD&CAct1940andrulesthereunder.Inthecaseofpharmaceuticalaidsitmayindicatethemorecommonusageofthearticle.Thestatementisnotintendedtolimitinanywaythechoiceoruseofthearticlenortoindicatethatithasnootheractivityoruse.“類別”項(xiàng)下的表述僅為通用信息，表明該藥品被藥典收載的醫(yī)學(xué)或藥學(xué)依據(jù)。其通常反映該藥品或其“類別”項(xiàng)下的表述還需符合1940（D&CAct1940）及其相關(guān)規(guī)則的規(guī)定。對(duì)于藥用輔料，“類別”項(xiàng)可能標(biāo)注其較常見的用途。該表述并非旨在以任何方式限制該藥品的選擇或使用，也不意味著該藥品無其他活性或用途。UsualstrengthThestatementontheusualstrength(s)ofapreparationgivenintheindividualmonographindicatesthestrength(s)usuallymarketedforinformationofthepharmacistandthemedicalpractitioner.Itdoesnotimplythatastrengthotherthantheone(s)mentionedintheindividualmonographmeetingalltheprescribedrequirementscannotbemanufacturedandmarketedwiththeapprovaloftheappropriateauthority.常用規(guī)格具體正文中“常用規(guī)格”項(xiàng)下的表述，列出了該制劑通常上市銷售的規(guī)格，供藥師和醫(yī)師參考。但這并不意味著，經(jīng)相關(guān)機(jī)構(gòu)批準(zhǔn)，不得生產(chǎn)和銷售其他符合所有規(guī)定要求的規(guī)格（非具體正文所列規(guī)格）。DescriptionThestatementsundertheheadingDescriptionarenottobeinterpretedinastrictsenseandarenottoberegardedasofficialrequirements.“性狀”項(xiàng)下的表述不應(yīng)作嚴(yán)格字面解讀，且不視為法定要求。SolubilityStatementsonsolubilityaregiveninChapter2.4.26andareintendedasinformationontheapproximatesolubilityatatemperaturebetween15°and30°,unlessotherwisestated,andarenottobeconsideredasofficialrequirements.However,atestforsolubilitystatedinamonographconstitutespartofthestandardsforthesubstancethatisthesubjectofthatmonograph.溶解度相關(guān)表述見第2.4.26章，除非另有說明，均指15℃~30℃范圍內(nèi)的近似溶解度，僅供參考，不視為法定要求。但若正文中標(biāo)注了溶解度試驗(yàn)，則該試驗(yàn)為該物質(zhì)法定標(biāo)準(zhǔn)的一部分。ResidualsolventsTherequirements,guidanceandinformationonresidualsolventsforpharmaceuticalusearegiveninthechapterentitledResidualSolvents(5.4).殘留溶劑藥用殘留溶劑的要求、指導(dǎo)原則及相關(guān)信息見“殘留溶劑”（第5.4章）。AllIParticlesaresubjecttorelevantcontrolofresidualsolvents,evenwhennotestisspecifiedintheindividualmonograph.Ifsolventsareusedduringproduction,theymustbeofsuitablequality.Inaddition,thetoxicityandresiduallevelofeachsolventshallbetakenintoconsiderationandthesolventslimitedaccordingtotheprinciplesdefinedandtherequirementsspecifiedinChapter5.4.ResidualSolvent,usingthegeneralmethodspresentedthereinorothersuitablemethods.所有印度藥典收載藥品均需符合殘留溶劑相關(guān)控制要求，即使具體正文未規(guī)定殘留溶劑試驗(yàn)。若生產(chǎn)過程中使用溶劑，該溶劑需符合適宜質(zhì)量要求。此外，需考慮每種溶劑的毒性及殘留水平，并根據(jù)第5.4章“殘留溶劑”中規(guī)定的原則和要求，采用該章所述通用方法或其他適宜方法控制溶劑殘留限度。TestMethods測(cè)試方法Referencestogeneralmethodsoftestingareindicatedbytestmethodnumbersinbracketsimmediatelyaftertheheadingofthetestorattheendofthetext.通用試驗(yàn)方法的引用，以試驗(yàn)項(xiàng)目標(biāo)題后或文本末尾括號(hào)內(nèi)的試驗(yàn)方法編號(hào)表示。IdentificationThetestsgivenundertheheadingIdentificationarenotnecessarilysufficienttoestablishabsoluteproofofidentity.Theyprovideameansofverifyingthattheidentityofthematerialunderexaminationisinaccordancewiththelabelonthecontainer.“鑒別”項(xiàng)下的試驗(yàn)并非一定能構(gòu)成對(duì)藥品身份的絕對(duì)證明。其僅用于核實(shí)供試品身份與容器標(biāo)簽標(biāo)注一致。Incertainmonographsalternativeseriesofidentificationtestsaregiven;compliancewitheitheroneortheothersetoftestsisadequatetoverifytheidentityofthearticle.部分正文列出了多組備選鑒別試驗(yàn)，符合其中任意一組試驗(yàn)要求，即可視為通過鑒別。Whentestsforinfraredabsorptionareappliedtomaterialextractedfromformulatedpreparations,strictconcordancewiththespecifiedreferencespectrummaynotalwaysbepossible,butneverthelessacloseresemblancebetweenthespectrumoftheextractedmaterialandthespecifiedreferencespectrumshouldbeachieved.當(dāng)對(duì)制劑中提取的物質(zhì)進(jìn)行紅外吸收試驗(yàn)時(shí)，其光譜未必能與規(guī)定的對(duì)照光譜完全一致，但提取物質(zhì)的光譜應(yīng)與規(guī)定對(duì)照光譜高度相似。TestsandAssays試驗(yàn)和測(cè)定ThetestsandassaysaretheofficialmethodsuponwhichthestandardsofthePharmacopoeiadepend.Therequirementsarenotframedtotakeintoaccountallpossibleimpurities.Itisnottobepresumed,forexample,thatanimpuritythatisnotdetectablebymeansoftheprescribedtestsistolerated.Materialfoundtocontainsuchanimpurityisnotofpharmacopoeialqualityifthenatureoramountoftheimpurityfoundisincompatiblewithgoodpharmaceuticalpractice.試驗(yàn)和測(cè)定方法為法定方法，是藥典標(biāo)準(zhǔn)的依據(jù)。相關(guān)要求并非為考慮所有可能的雜質(zhì)而制定。例如，不得默認(rèn)規(guī)定試驗(yàn)無法檢出的雜質(zhì)即為允許存在的雜質(zhì)。若供試品中發(fā)現(xiàn)的雜質(zhì)性質(zhì)或含量不符合藥品生產(chǎn)質(zhì)量管理規(guī)范要求，則該供試品不符合藥典質(zhì)量要求。Pharmacopoeialmethodsandlimitsshouldbeusedmerelyascompliancerequirementsandnotasrequirementstoguaranteetotalqualityassurance.Testsandassaysareprescribedfortheminimumsampleavailableonwhichtheattributesofthearticleshouldbemeasured.Assuranceofqualitymustbeensuredbythemanufacturerbytheuseofstatisticallyvalidsamplingandtestingprogrammes.藥典方法與限度僅應(yīng)作為合規(guī)性要求，而非保障全面質(zhì)量保證的要求。檢查與測(cè)定法針對(duì)可供使用的最小樣品制定，用于測(cè)定該藥品的各項(xiàng)屬性。生產(chǎn)商必須通過采用統(tǒng)計(jì)學(xué)有效的取樣及檢驗(yàn)方案，確保質(zhì)量保證。TestsUnlessotherwisestated,theassaysandtestsarecarriedoutatatemperaturebetween20°and30°.除非另有說明，測(cè)定和試驗(yàn)均在20℃~30℃下進(jìn)行。Whereitisdirectedthatananalyticaloperationistobecarriedout‘insubduedlight’,precautionsshouldbetakentoavoidexposuretodirectsunlightorotherstronglight.Whereaprocedureisdirectedtobeperformed‘protectedfromlight’precautionsshouldbetakentoexcludeactiniclightbytheuseoflow-actinicglassware,workinginadarkroomorsimilarprocedures.若要求分析操作在“弱光下”進(jìn)行，應(yīng)采取預(yù)防措施，避免暴露于直射陽光或其他強(qiáng)光下。若要求操作“避光”進(jìn)行，應(yīng)采用低透光率玻璃器皿、在暗室中操作或其他類似方法，避免光化射線照射。Forpreparationsotherthanthoseoffixedstrength,thequantitytobetakenforatestoranassayisusuallyexpressedintermsoftheactiveingredient.Thismeansthatthequantityof