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JPXVIIITheofficialnameofthispharmacopoeiais第十八改正日本薬局方andmaybeabbreviatedas日局十八,日局18JPXVIIIorJP18.本藥典的官方名稱為第十八改正日本藥典，可縮寫為日局十八、日局18、JPXVIII或JP18。TheEnglishnameofthispharmacopoeiaisTheJapanesePharmacopoeia,EighteenthEdition.本藥典的英文名稱為《日本藥典第十八版》（TheJapanesePharmacopoeia,EighteenthEdition）。Amongdrugs,theJapanesePharmacopoeiaDrugs(theJPDrugs)arethosespecifiedinthemonographs.Thetitlenamesandthecommonlyusednamesadoptedinthemonographshouldbeusedasofficialnames.Inthedrugmonograph,inadditiontoEnglishname,chemicalnameorLatinnamecanbementionedinthetitle,asappropriate.藥品中，日本藥典藥品（簡稱JP藥品）指各論中規(guī)定的藥品。各論采用的標(biāo)題名及常用名作為法定名稱。藥品各論的標(biāo)題中，除英文名稱外，可根據(jù)需要標(biāo)注化學(xué)名稱或拉丁名稱。CrudeDrugsandtheirrelatedproductsareplacedtogetherin``CrudeDrugsandRelatedDrugs''intheposteriorpartoftheOfficialMonographs.Theseinclude:Extracts,Powders,Tinctures,Syrups,Spirits,FluidextractsorSuppositoriescontainingCrudeDrugsastheactiveingredient,andcombinationpreparationscontainingCrudeDrugsastheprincipalactiveingredient.藥材及其相關(guān)制品集中列于法定各論后部的“藥材及相關(guān)藥品”酊劑、糖漿劑、醑劑、流浸膏劑或栓劑，以及以藥材為主要活性成分的復(fù)方制劑。TheJPDrugsaretobetestedaccordingtotheprovisionsgiveninthepertinentmonographs,GeneralNotices,GeneralRulesforCrudeDrugs,GeneralRulesforPreparations,andGeneralTestsfortheirconformitytotheJapanesePharmacopoeia.However,theheadingsofDescription''andinadditionContainersandstorage''andShelflife''inthemonographsonpreparationsaregivenforinformation,andshouldnotbetakenasindicatingstandardsforconformity.Nevertheless,ContainersunderContainersandstorage''inthemonographonpreparationscontainingcrudedrugsasmainactiveingredientsarethestandardsforconformity.日本藥典藥品應(yīng)依據(jù)相關(guān)各論、通用注意事項(xiàng)、藥材通則、制劑通則及一般試驗(yàn)法的規(guī)定進(jìn)行檢驗(yàn)，以符合日本藥典要求。但制劑各論中的“性狀”項(xiàng)下，以及“容器與貯藏”和“有效期”項(xiàng)下的內(nèi)容僅為參考信息，不“容器與貯藏”項(xiàng)下的容器要求為符合性標(biāo)準(zhǔn)。Inprinciple,unlessotherwisespecified,animalsusedforpreparingtheJPDrugsortheirsourcematerialsmustbehealthy.原則上，除非另有規(guī)定，用于制備日本藥典藥品或其原料的動物必須健康。InthisEnglishversion,theJPDrugsdescribedinthemonographsbeginwithacapitalletter.本英文版本中，各論所述的日本藥典藥品名稱首字母大寫。Themolecularformulasorconstitutionformulasinparentheses()afterthenameofdrugsorchemicalsdesignatechemicallypuresubstances.AtomicmassesadoptedintheJapanesePharmacopoeiaconformtothetableofAtomicWeightsoftheElements2015''(IUPAC)-StandardAtomicWeights2017(AtomicWeightsSubcommitteeoftheChemicalSocietyofJapan).However,theatomicmassesoftheelementswhoseatomicweightisindicatedwithanintervalinthe2015tableconformtothetableofAtomicWeightsoftheElements2007''(IUPAC)-StandardAtomicWeights2010(AtomicWeightsSubcommitteeoftheChemicalSocietyofJapan).Molecularmassesareindicatedtotwodecimalplacesroundedfromthreedecimals.藥品或化學(xué)品名稱后括號內(nèi)的分子式或結(jié)構(gòu)式表示化學(xué)純物質(zhì)。日本藥典采用的原子量符合《2015年元素原子量表》（IUPAC）-《2017年標(biāo)準(zhǔn)原子量》（日本化學(xué)會原子量委員會）的規(guī)定。但2015年量表中原子量標(biāo)注為區(qū)間值的元素，其原子量遵循《2007年元素原子量表》（IUPAC）-《2010年標(biāo)準(zhǔn)原子量》（日本化學(xué)會原子量委員會）的規(guī)定。分子量按三位小數(shù)四舍五入后保留兩位小數(shù)表示。Thefollowingabbreviationsareusedfortheprincipalunits.主要單位用以下縮寫表示meter米mcentimeter厘米cmmillimeter毫米mmmicrometer微米μmnanometer納米nmkilogram千克kggram克gmilligram毫克mgmicrogram微克μgnanogram納克ngpicogram皮克pgCelsiusdegree攝氏度°Cmole摩爾molmillimole毫摩爾mmolsquarecentimeter平方厘米cm2liter升Lmilliliter毫升mLmicroliter微升μLmegahertz兆赫茲MHzpercentimeter每厘米cm?1newton牛頓Nkilopascal千帕斯卡kPapascal帕斯卡Papascalsecond帕斯卡·秒Pa·smillipascalsecond毫帕斯卡·秒mPa·ssquaremillimeterpersecond平方毫米每秒mm2/slux勒克斯lxmoleperliter摩爾每升mol/L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millimoleperliter毫摩爾每升mmol/Lmasspercent質(zhì)量分?jǐn)?shù)%(質(zhì)量分?jǐn)?shù))masspartspermillion百萬分之質(zhì)量分?jǐn)?shù)ppm質(zhì)量分?jǐn)?shù))masspartsperbillion十億分之質(zhì)量分?jǐn)?shù)ppb質(zhì)量分?jǐn)?shù))volumepercent體積分?jǐn)?shù)vol體積分?jǐn)?shù))volumepartspermillion百萬分之體積分?jǐn)?shù)volppm體積分?jǐn)?shù))masspervolumepercent質(zhì)量體積分?jǐn)?shù)w/v質(zhì)量體積分?jǐn)?shù))microsiemenspercentimeter微西門子每厘米μS·cm?1endotoxinunit內(nèi)毒素單位EUcolonyformingunit菌落形成單位CFUNote:ppm''usedintheNuclearMagneticResonanceSpectroscopyindicatesthechemicalshift,andw/v%''isusedintheformulaorcompositionofpreparations.注：核磁共振光譜中使用的“ppm”表示化學(xué)位移，“w/v%”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TheunitusedforexpressingthepotencyoftheJPDrugsisrecognizedasthequantityofdrug.TheJPDrugsaretobetestedaccordingtotheprovisionsgiveninthepertinentmonographs,GeneralNotices,GeneralRulesforCrudeDrugs,GeneralRulesforPreparations,andGeneralTestsfortheirconformitytotheJapanesePharmacopoeia.(SeetheGeneralNotices5.)Usuallyitisexpressedbyadefinitequantityofadefinitestandardsubstancewhichshowsadefinitebiologicalactivity,anddiffersaccordingtoeachdrug.Theunitsaredetermined,inprinciple,bycomparisonwitheachreferencestandardbymeansofbiologicalmethods.Theterm``Unit''usedfortheJParticlesindicatestheunitdefinedintheJapanesePharmacopoeia.表示日本藥典藥品效價(jià)的單位為藥品的法定計(jì)量單位。日本藥典藥品應(yīng)依據(jù)相關(guān)各論、通用注意事項(xiàng)、藥材通則、制劑通則及一般試驗(yàn)法的規(guī)定進(jìn)行檢驗(yàn)，以符合日本藥典要求（見通用注意事項(xiàng)第5條）。效價(jià)單位通常以具有特定生物活性的標(biāo)準(zhǔn)物質(zhì)的一定數(shù)量表示，且因藥品而異。原則上，效價(jià)單位通過生物測定法與相應(yīng)對照品比對確定。日本藥典藥品中使用的“單位（Unit）”指日本藥典中定義的單位。Thestatement``Beingspecifiedseparately.''inthemonographsmeansthatthetestsaretobespecifiedwhenthedrugsaregrantedapprovalbasedontheLawonSecuringQuality,EfficacyandSafetyofProductsincludingPharmaceuticalsandMedicalDevices.各論中“另行規(guī)定”的表述，指該藥品依據(jù)《藥事法》（含藥品及醫(yī)療器械等產(chǎn)品質(zhì)量、有效性和安全性保障相關(guān)法律）獲得批準(zhǔn)時(shí)，將明確相關(guān)檢驗(yàn)要求。Fromthepointofviewofqualityassurance,requirementsthatshouldbenotedonmanufacturingprocesses,ifappropriateinadditiontothespecifications,areshownintheheadingManufacture''inmonograph.Itmaycontainrequirementsregardingcontrolofmaterials,manufacturingprocessesandintermediates,andrequirementsregardingtestsinprocessandomissionoftestsfortherelease.Thefulfilmentofrequirementsmentionedinthisheadingareconfirmedbasedontheinformationobtainedduringtheestablishmentofmanufacturingmethodatthedevelopmentstage,thecontrolofmanufacturingprocesses,orthetestsfortherelease.AlsoeveninthecaseofabsenceoftheheadingManufacture''inmonograph,itisimportanttonoteappropriatecontrolsofmaterials,manufacturingprocessesandintermediatesinindividualdrugs.從質(zhì)量保證角度出發(fā)，除質(zhì)量標(biāo)準(zhǔn)外，各論中“生產(chǎn)”項(xiàng)下將酌情列出生產(chǎn)過程中應(yīng)注意的要求。該部分可能包括原料、生產(chǎn)工藝及中間體的控制要求，以及過程檢驗(yàn)和放行檢驗(yàn)豁免的相關(guān)規(guī)定。該項(xiàng)下要求的符合性，通過研發(fā)階段工藝建立過程中獲取的信息、生產(chǎn)過程控制情況或放行檢驗(yàn)結(jié)果予以確認(rèn)。即使各論中未設(shè)“生產(chǎn)”項(xiàng)下，各藥品也應(yīng)重視對原料、生產(chǎn)工藝及中間體的適當(dāng)控制。WhenanassurancethataproductisoftheJPDrugqualityisobtainedconsistentlyfromdataderivedfromthemanufacturingprocessvalidationstudies,andfromtherecordsofappropriatemanufacturingprocesscontrolandofthetestresultsofthequalitycontrol,theperformanceofsometestitemsinthemonographatreleaseonaproductmaybeomittedasoccasiondemands.Moreover,thequalityevaluationoffinalproducts(drugsubstancesanddrugproducts)basedonin-processdataincludingin-processtestingresultsandmonitoringdataonprocessparameterscanreplacespecificspecificationsandtestmethodsinthemonographorperformingthetestmethods,ifappropriate.若通過生產(chǎn)工藝驗(yàn)證研究數(shù)據(jù)、適當(dāng)?shù)纳a(chǎn)過程控制記錄及質(zhì)量控制檢驗(yàn)結(jié)果，能夠持續(xù)確認(rèn)產(chǎn)品符合日本藥典藥品質(zhì)量要求，可根據(jù)需要豁免部分各論中規(guī)定的放行檢驗(yàn)項(xiàng)目。此外，若合適，基于過程檢驗(yàn)結(jié)果、工藝參數(shù)監(jiān)測數(shù)據(jù)等過程數(shù)據(jù)對成品（原料藥及制劑）進(jìn)行的質(zhì)量評價(jià)，可替代各論中的特定質(zhì)量標(biāo)準(zhǔn)、檢驗(yàn)方法或免除該檢驗(yàn)方法的執(zhí)行。ThetestmethodsspecifiedintheJapanesePharmacopoeiacanbereplacedbyalternativemethodswhichgivebetteraccuracyandprecision.However,whereadifferenceintestresultsissuspected,onlytheresultobtainedbytheproceduregiveninthePharmacopoeiaiseffectiveforthefinaljudgment.日本藥典規(guī)定的檢驗(yàn)方法可采用準(zhǔn)確度和精密度更優(yōu)的替代方法。但當(dāng)懷疑檢驗(yàn)結(jié)果存在差異時(shí)，僅藥典規(guī)定方法得出的結(jié)果可作為最終判定依據(jù)。Thedetailsofthebiologicaltestmethodsmaybechangedinsofarastheydonotaffecttheessentialqualitiesofthetest.生物檢驗(yàn)方法的細(xì)節(jié)可在不影響檢驗(yàn)核心質(zhì)量的前提下進(jìn)行修改。Thetemperatureforthetestsorstorageisdescribed,inprinciple,inspecificfigures.However,thefollowingexpressionsmaybeusedinstead.Standardtemperature,ordinarytemperature,roomtemperature,andlukewarmaredefinedas20°C,15–25°C,1–30°C,and30–40°C,respectively.Acoldplace,unlessotherwisespecified,shallbeaplacehavingatemperatureof1–15°C.Thetemperatureofcoldwater,lukewarmwater,warmwater,andhotwateraredefinedasnotexceeding10°C,30–40°C,60–70°C,andabout100°C,respectively.Thetermheatedsolvent''orhotsolvent''meansasolventheatedalmosttotheboilingpointofthesolvent,andthetermwarmedsolvent''orwarmsolvent''usuallymeansasolventheatedtoatemperaturebetween60°Cand70°C.Theterm``heatonorinawaterbath''indicates,unlessotherwisespecified,heatingwithaboilingwaterbathorasteambathatabout100°C.Coldextractionandwarmextractionareusuallyperformedattemperaturesof15–25°Cand35–45°C,respectively.檢驗(yàn)或貯藏溫度原則上以具體數(shù)值表示，也可采用下列表述。標(biāo)準(zhǔn)溫度、常溫、室溫、微溫分別定義為20℃、15–25℃、1–30℃、30–40℃。冷處，除非另有規(guī)定，指溫度為1–15℃的場所。冷水、微溫水、溫水、熱水的溫度分別定義為不超過10℃、30–40℃、60–70℃、約100℃。“加熱溶劑”或“熱溶劑”指加熱至接近沸點(diǎn)的“水浴加熱”，除非另有規(guī)定，指采用沸水浴或約100℃的蒸汽浴加熱。冷浸提取和溫浸提取通常分別在15–25℃和35–45℃下進(jìn)行。Tomeasurethenumberofdrops,adroppingdevicewhichdelivers20dropsofwaterweighing0.90–1.10gat20°Cshallbeused.滴數(shù)測定應(yīng)使用特定滴液裝置，該裝置在20℃時(shí)滴出20滴水的質(zhì)量為0.90–1.10g。Theterm``invacuum''indicates,unlessotherwisespecified,apressurenotexceeding2.0kPa.“真空下”，除非另有規(guī)定，指壓力不超過2.0kPa。Theacidityoralkalinityofasolution,unlessotherwisespecified,isdeterminedbyblueorredlitmuspapers.Toindicatethesepropertiesmoreprecisely,pHvaluesareused.溶液的酸堿性，除非另有規(guī)定，采用藍(lán)色或紅色石蕊試紙測定。如需更精確表示，可使用pH值。ThetermsinTable1areusedtoexpressthedegreeofcuttingofCrudeDrugsorfinenessofpowderDrugs.表1中的術(shù)語用于表示藥材的切段程度或粉末狀藥品的細(xì)度。Table1No.篩號46.58.61850100200Nominal4750μm2800μm2000μm850μm300μm150μm75μmionofsieve篩孔公稱尺寸Namesofthedrugswhichpassthroughtherespectivesieves通過相應(yīng)篩網(wǎng)的藥品名稱CoarsecuttingModeratelyfinecutting中切段FinecuttingCoarsepowder粗粉Moderatelyfinepowder中粉Finepowder細(xì)粉VeryfinepowderThewatertobeusedinthetestsofdrugsshallbethewatersuitableforperformingtherelevanttest,suchasthewaternotcontaininganysubstancethatwouldinterferewiththetest.藥品檢驗(yàn)所用的水應(yīng)為適合相關(guān)檢驗(yàn)的水，如不含干擾檢驗(yàn)的物質(zhì)。Asforwordingsolutionofasolute'',wherethenameofthesolventisnotstated,thetermsolution''indicatesasolutioninwater.對于“某溶質(zhì)的溶液”表述，若未注明溶劑名稱，“溶液”指水溶液。Forsolutionanexpressionsuchas(1in3)'',(1in10)'',or(1in100)''meansthat1gofasolidisdissolvedin,or1mLofaliquidisdilutedwiththesolventtomakethetotalvolumeof3mL,10mLor100mL,respectively.Fortheliquidmixtureanexpressionsuchas(10:1)''or``(5:3:1)''meansthattherespectivenumbersofparts,byvolume,ofthedesignatedliquidsaretobemixed.溶液中“（1→3）”“（1→10）”或“（1→100）”等表述，指1g固體溶解于溶劑中，或1mL液體用溶劑稀釋，使總體積分別達(dá)到3mL、10mL或100mL。液體混合物中“（10:1）”或“（5:3:1）”等表述，指按指定液體的體積份數(shù)進(jìn)行混合。Thetermweighaccurately''meanstoweighdowntothedegreeof0.1mg,10mg,1mgor0.1mgbytakingintoaccountthepurposeofthetestandusingarelevantweighingdevice.Thetermweighexactly''meanstoweightothegivendecimalplaces.“精密稱定”指根據(jù)檢驗(yàn)?zāi)康?，使用相?yīng)稱量儀器，稱量至0.1mg、10mg、1mg或0.1mg精度?！皽?zhǔn)確稱量”指稱量至規(guī)定的小數(shù)位數(shù)。Avalueofn''figuresinatestoftheJPDrugsshallbeobtainedbyroundingoffavalueofn+1''figures.日本藥典藥品檢驗(yàn)中，n位有效數(shù)字的數(shù)值通過對n+1位有效數(shù)字的數(shù)值四舍五入獲得。Unlessotherwisespecified,alltestsoftheJPDrugsshallbeperformedattheordinarytemperatureandobservationsoftheresultsshallfollowimmediatelyaftertheoperations.However,thejudgmentforatestwhichisaffectedbytemperatureshouldbebasedontheconditionsatthestandardtemperature.除非另有規(guī)定，日本藥典藥品的所有檢驗(yàn)均在常溫下進(jìn)行，操作后立即觀察結(jié)果。但受溫度影響的檢驗(yàn)，其判定應(yīng)基于標(biāo)準(zhǔn)溫度條件下的結(jié)果。Thetermsimmediately''/atonce''usedinthetestoftheJPDrugsmeanthattheprocedureistobeperformedwithin30secondsaftertheprecedingprocedure.日本藥典藥品檢驗(yàn)中使用的“立即”表述，指該操作應(yīng)在前一操作完成后30秒內(nèi)進(jìn)行。InthesectionundertheheadingDescription,thetermwhite''isusedtoindicatewhiteorpracticallywhite,andcolorless''iscolorlessorpracticallycolorless.Unlessotherwisespecified,thetestofcoloriscarriedoutbyplacing1gofasoliddrugonasheetofwhitepaperorinawatchglassplacedonwhitepaper.Aliquiddrugisputintoacolorlesstesttubeof15-mminternaldiameterandisobservedinfrontofawhitebackgroundthroughalayerof30mm.Forthetestofclarityofliquiddrugsthesameprocedureisappliedwitheitherablackorwhitebackground.Fortheobservationoffluorescenceofaliquiddrug,onlyablackbackgroundshallbeused.“性狀”項(xiàng)下，“白色”指白色或類白色，“無色”指無色或幾乎無色。除非另有規(guī)定，顏色檢驗(yàn)方法為：取1g固體藥品置于白紙上或白紙上的表面皿中觀察；取液體藥品置于內(nèi)徑15mm的無色試管中，在白色背景前通過30mm液層觀察。液體藥品的澄清度檢驗(yàn)采用相同操作，可在黑色或白色背景下進(jìn)行；液體藥品的熒光觀察僅在黑色背景下進(jìn)行。InthesectionundertheheadingDescription,theterm``odorless''isusedtoindicateodorlessorpracticallyodorless.Unlessotherwisespecified,thetestofodorshallbecarriedoutbyplacing1gofasoliddrugor1mLofaliquiddruginabeaker.“性狀”項(xiàng)下，“無臭”指無臭或幾乎無臭。除非另有規(guī)定，氣味檢驗(yàn)方法為：取1g固體藥品或1mL液體藥品置于燒杯中觀察。InthesectionundertheheadingDescription,solubilitiesareexpressedbythetermsinTable2.Unlessotherwisespecified,solubilitymeansthedegreeofdissolutionoftheJPDrugs,previouslypowderedinthecaseofasoliddrug,within30minutesinasolventat20±5°C,byvigorousshakingfor30secondseachtimeat5-minuteintervals.“性狀”項(xiàng)下，溶解度采用表2中的術(shù)語表示。除非另有規(guī)定，溶解度指日本藥典藥品在20±5℃條件下，于溶劑中溶解的程度（固體藥品需預(yù)先粉碎）。溶解過程為每間隔5分鐘劇烈振搖30秒，持續(xù)30分鐘。Table2Descriptiveterm描述術(shù)語Volumeofsolventrequiredfordissolving1gor1mLofsolute溶解1g或1mL溶質(zhì)所需溶劑體積Verysoluble極易溶解Lessthan1mL小于1mLFreelysoluble易溶From1mLtolessthan10mL1mL至小于10mLSoluble溶解From10mLtolessthan30mL10mL至小于30mLSparinglysoluble略溶From30mLtolessthan100mL30mL至小于100mLSlightlysoluble微溶From100mLtolessthan1000mL100mL至小于1000mLVeryslightlysoluble極微溶解From1000mLtolessthan10000mL1000mL至小于10000mLPracticallyinsoluble,orinsoluble幾乎不溶或不溶10000mLandover10000mL及以上Inthetestofadrug,thetermdissolve''ormiscible''indicatesthatitdissolvesin,ormixesinarbitraryproportionwiththesolventtoformaclearsolutionormixture.Insolublematerialsotherthanthedrugincludingfibersshouldnotbedetectedorpracticallyinvisible,ifany.藥品檢驗(yàn)中，“溶解”或“混溶”指藥品溶解于溶劑中，或與溶劑按任意比例混合，形成澄清溶液或混合物。除藥品外，不得檢出纖維等不溶性雜質(zhì)；若有，應(yīng)幾乎不可見。Identificationisthetesttoidentifytheactiveingredient(s)ofthedrugbaseduponitsspecificproperty.鑒別是依據(jù)藥品的特有性質(zhì)，確認(rèn)其活性成分的檢驗(yàn)項(xiàng)目。Purityisthetesttodetectimpurities/contaminantsindrugs,andit,aswellasotherrequirementsineachmonograph,specifiesthepurityofthedrugusuallybylimitingthekind/natureandquantityoftheimpurities/contaminants.Theimpurities/contaminantssubjecttothepuritytestarethosesupposedtogenerate/contaminateduringthemanufacturingprocessorstorage,includinghazardousagentssuchasheavymetals,arsenic,etc.Ifanyforeignsubstancesareusedorsupposedtobeadded,itisnecessarytoperformteststodetectorlimitthepresenceofsuchsubstances.純度檢驗(yàn)是檢測藥品中雜質(zhì)/污染物的項(xiàng)目，與各論中的其他要求一致，通常通過限定雜質(zhì)/污染物的種類、性質(zhì)及含量來明確藥品純度。純度檢驗(yàn)的雜質(zhì)/污染物包括生產(chǎn)或貯藏過程中可能產(chǎn)生或引入的物質(zhì)，如重金屬、砷等有害物質(zhì)。若使用或可能引入外來物質(zhì)，需進(jìn)行相應(yīng)檢驗(yàn)以檢測或限制其存在。Inprinciple,theJPDrugProductsarecontrolledappropriatelyaccordingtothedirectionunderElementalImpuritiesoftheGeneralTests.Whenelementalimpuritiesinthedrugproductsareappropriatelycontrolledinaccordancewiththedirection,itisnotnecessarytoperformthetestsonelementalimpuritiessuchasheavymetalsandarsenicspecifiedinthemonographsincluding,butnotlimitedto,thoseofdrugproducts,drugsubstancesandexcipients.原則上，日本藥典制劑應(yīng)按照一般試驗(yàn)法中“元素雜質(zhì)”據(jù)該要求得到適當(dāng)控制，則無需進(jìn)行各論（包括但不限于制劑、原料藥及輔料各論）中規(guī)定的重金屬、砷等元素雜質(zhì)檢驗(yàn)。Inprinciple,unlessspecifiedinthemonograph,theJPDrugsarecontrolledappropriatelyaccordingtothedirectionunderResidualSolventsofthegeneraltests.原則上，除非各論另有規(guī)定，日本藥典藥品應(yīng)按照一般試驗(yàn)法中“殘留溶劑”項(xiàng)下的要求進(jìn)行適當(dāng)控制。Concerningharmfulsubstancesreportedasintentionallycontaminatedtodrugs,thecontrolrequirementforthepresenceorabsenceofcontaminationisdescribedintheheading``Potentialadulteration''inthemonograph,asnecessary.Thesesubstancesarecontrolledbytestsonmaterials,manufacturingprocesses,intermediates,orfinalproducts.Thenecessityandfrequencyofthetestsarespecifiedseparatelyonindividualdrugsdependingonthecontrolstrategyestablishedaspartofqualityriskmanagement.對于有報(bào)告稱可能被故意摻入藥品的有害物質(zhì)，各論中“潛在摻雜物”項(xiàng)下將根據(jù)需要明確其污染控制要求。此類物質(zhì)通過原料、生產(chǎn)工藝、中間體或成品檢驗(yàn)進(jìn)行控制。檢驗(yàn)的必要性及頻次，根據(jù)質(zhì)量風(fēng)險(xiǎn)管理制定的控制策略，針對各藥品另行規(guī)定。Theterm``constantmass''indryingorignition,unlessotherwisespecified,meansthatthemassdifferenceafteranadditional1hourofdryingorignitionisnotmorethan0.10%oftheprecedingmassofthedriedsubstanceorignitedresidue.ForCrudeDrugs,thedifferenceisnotmorethan0.25%.However,whenthedifferencedoesnotexceed0.5mginachemicalbalance,50mginasemi-microbalance,or5mginamicrobalance,theconstantmasshasbeenattained.干燥或熾灼中的“恒重”，除非另有規(guī)定，指連續(xù)干燥或熾灼1小時(shí)后，兩次質(zhì)量差異不超過前一次干燥物質(zhì)或熾灼殘?jiān)|(zhì)量的0.10%。藥材的恒重差異不超過0.25%。但使用化學(xué)天平稱量時(shí)，差異不超過0.5mg；使用半微量天平稱量時(shí)，差異不超過50mg；使用微量天平稱量時(shí)，差異不超過5mg，即視為達(dá)到恒重。Assayisthetesttodeterminethecomposition,thecontentoftheactiveingredients,andthepotencyunitofmedicinebyphysical,chemicalorbiologicalprocedures.含量測定是通過物理、化學(xué)或生物方法，測定藥品的組成、活性成分含量及效價(jià)單位的檢驗(yàn)項(xiàng)目。Instatingtheappropriatequantitiestobetakenforassay,theuseofthewordabout''indicatesaquantitywithin10%ofthespecifiedmass.Theworddry''inrespectofthesampleindicatesdryingunderthesameconditions,asdescribedinLossondryinginthemonograph.含量測定中“約取”的表述，指取用量為規(guī)定質(zhì)量的±10%范圍內(nèi)。樣品相關(guān)的“干燥”表述，指按照各論中“干燥失重”項(xiàng)下規(guī)定的條件進(jìn)行干燥。ForthecontentofaningredientdeterminedbyAssayinthemonographs,ifitisexpressedsimplyas``notlessthanacertainpercentage''withoutindicatingitsupperlimit,101.0%isunderstoodastheupperlimit.各論中含量測定項(xiàng)下的成分含量，若僅表述為“不得低于某一百分比”而未注明上限，其上限默認(rèn)為101.0%。Sterilitymeansaconditionwhennotargetmicroorganismisdetectedbythespecifiedmethod.Sterilizationmeansaprocesswherebykillingorremovalofalllivingmicroorganismsinanobjecttobesterilizedisaccomplished.Aseptictechniqueiscontrolledtechniquetomaintaintheasepticcondition.無菌指通過規(guī)定方法未檢出目標(biāo)微生物的狀態(tài)。滅菌指殺滅或去除待滅菌物品中所有活微生物的過程。無菌操作法是維持無菌狀態(tài)的受控操作技術(shù)。ThecontaineristhedevicewhichholdstheJPDrugs.Thestopperorcap,etc.,isconsideredaspartofthecontainer.Thecontainershavenophysicalandchemicalreactivityaffectingthespecifieddescriptionandqualityofthecontents.容器指盛裝日本藥典藥品的器具，瓶塞、瓶蓋等視為容器的組成部分。容器不得與內(nèi)容物發(fā)生影響其規(guī)定性狀及質(zhì)量的物理或化學(xué)反應(yīng)。Awell-closedcontainerprotectsthecontentsfromextraneoussolidsandfromlossofthedrugunderordinaryorcustomaryco