1.2.other provisions applying to general chapters and monographs
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财产保险合同(英文) propertyinsuranceclauseswholedoc.i.thepropertyinsured thepropertyinsuredshallrefertoallpropertiesandexpensesspe- cifiedinthescheduleofthispolicy. unlessspecificallyagreeduponinwritingbetweentheinsuredandthecompanyandappraisedandvalue-establishedbyprofessionalsorassessors,thefollowingarticlesandtheexpensesrelevanttheretoshallnotbe coveredunderthispolicy:1.gold,silver,pearls,diamonds,preciousstonesandjades;2.antiques,articlesofvirtue,ancientcoins,ancientbooksand ancientpaintings;3.worksofartorpostagestamps;4.advertisements,aerials,neon,piecesofsolarenergyapparatusetc.onbuildings;putersystemrecordsoritsmakingandcopyingcosts. undernocircumstancesshallthefollowingarticlesrelevantthereto becoveredhereunder:1.guns,ammunitionorexplosives;2.banknotes,securities,bills,documents,files,accountbooksor drawings;3.animals,plantsandagriculturalcrops;4.mobilephones,portablecomputers,removablephotographapparatus orotherpreciousarticles;5.vehicleslicensedforgeneraltransportuse.ii.scopeofcover thecompanyshallindemnifytheinsuredinrespectofthephysical lossofordamagetotheinsuredpropertystatedinthescheduleduring theperiodofinsurancedirectlyarisingfromthefollowingperils: 1.fire;2.explosion; butnotincludingexplosionofaboilerorotherpressurerelief devices;3.lightning;4.hurricane,typhoonandtornado;5.storm,tempestandflood; butnotincludinglossordamagecausedbychangeinnormalwater levelorinundationfromseawaterorwaterescapeorleakagefromthe normalconfinesofanynaturalwatercourse,lakeorreservoir,canalor damaswellaslossofordamagetotheinsuredpropertycausedbystorm, tempestorfloodwhilebeingstoredintheopenorcoveredbyorundera shedthatchedwithreeds,tarpaulins,straw,asphaltfelt,plasticor nylonsheet;6.hailstorm;ndslide,rockslide,avalanche;8.volcanicexplosion;9.subsidenceofground;butnotincludinglossordamageresultingfrompiledriving, groundworkorexcavation;10.crashingaircraftandpartsorarticlesfallingfromaircraftand otherflyingobjects;11.burstingofwatertankorpipe; butnotincludingburstingofwatertankorpipeduetorust.iii.exclusionsthiscompanyshallnotbeliablefor:1.lossofordamagetotheinsuredpropertyorexpensescausedbyintentionalactorgrossnegligenceoftheinsuredorhisrepresentativ e;2.lossofordamagetotheinsuredpropertycausedandexpenses incurredbyearthquakeortsunami;3.depreciation,lossofmarket,lossofuseandotherconsequential lossesofanydescription;4.lossofordamagetotheinsuredpropertyorexpensesincurredarisingfromwar,warlikeoperation,hostilities,armedconflicts,terrorism,conspiracyinsurrection,coupdetat,strike,riot,andciv ilcommotion;5.confiscation,requisition,destructionordamagebyanyactionor orderofanygovernmentdejureordefactoorbyanypublicauthorities;6.lossofordamagetoinsuredpropertydirectlyorindirectlycausedorexpensesincurredbynuclearfission,nuclearfusion,nuclearweapo n,nuclearmaterial,nuclearradiationandradioactivecontamination;7.lossordamagecausedandexpensesincurredbypollutionofany kindordescriptionwhatsoeversuchasatmosphere,landandwater pollutionsbutthisdoesnotincludelossordamagecausedbypollution arisingfromperilsspecifiedinarticleiithepolicy;8.thedeductiblesstatedinthescheduletobebornebytheinsured;9.lossordamagearisingfromanyotherperilsnotlistedinarticle iiofthispolicy.iv.treatmentofclaim1.thecompanyshallatitsoption,indemnifytheinsuredinrespect oflossordamagefallingwithinthescopeofcoverofthepolicyby either:1.1payingtheamountoftheactualvalueofthepropertylostor damagedor;1.2payingthenecessarycostofrepairingorrestoringthedamaged propertytoitsnearestconditionimmediatelyprecedingthedamageor;1.3repairingorrestoringthedamagedpropertytoaconditionnearto otherpropertyoflikekindandquality.2.indemnityunderthispolicyshallbebaseduponthesoundmarket valueofthepropertyprevailingatthetimeofloss.ifthesoundmarket valueofthedamagedpropertyislowerthanthesuminsuredofsuch property,theclaimshallbesettledonitsmarketvalue;ifthesoundmarketvalueofthepropertyisinexcessofthesuminsured,thecompanyshallonlybeliableforsuchproportionoftheclaimasthesuminsured ofthedamagedpropertybearstoitssoundmarketvalue.iftheinsured propertyenumeratedinthescheduleismorethanoneitem,theprovision ofthisclauseshallapplytoeachthereof.3.ifaclaimforlossofordamagetotheinsureditemissettledon atotallossbasis,thesalvagevalueofsuchitemshallbedeductedfrom theindemnitypayablebythecompany.thecompanymay,atitsoption, declinetheabandonmentofanydamagedpropertybytheinsured.4.intheeventoflossofordamagetoanyequipmentiteminsured formingpartofapairorset,thecompanyshallnotbeliableinrespect ofeachofsuchitemlostordamagedformorethanitsproportionatepart ofthesuminsuredonthecompletepairorset.5.intheeventofanylossoccurrence,thecompanyshallalsopaytheinsuredfortheexpensesreasonablyincurredfortakingnecessarymeas urestominimizelossordamagetotheleastextent,butinnocaseshallsuchexpensesreferredheretoexceedthesuminsuredoftheinsuredproperty.6.uponsettlementofaclaim,anendorsementshallbeissuedbythe companytoreducethesuminsuredcorrespondingtothepropertylostor damagedbytheamountsosettledfromthedateofloss,andnopremium shallberefundedfortheamountsoreduced.ifreinstatementofthesum insuredisrequiredbytheinsureduponsettlementoftheclaim,anadditionalpremiumforthereinstatedamountshallbechargedatanagre edrate,andbecalculatedonproratadailybasisfromthedateoflossto theexpiryoftheinsurance.7.thetimeofvalidityofaclaimunderthisinsuranceshallnot exceedaperiodoftwoyearcountingfromthedateofloss.v.insuredsobligations thefollowingobligationsshallbestrictlyfulfilledbytheinsured andhisrepresentative:1.theinsuredandhisrepresentative,whenapplyingforinsuranceshallmaketrueanswersordescriptionstothequestionsintheproposal andquestionnaireortoanyotherquestionsraisedbythecompany.2.theinsuredandhisrepresentativeshallpaytothecompanyindue coursetheagreedpremiuminthemannerasprovidedinthescheduleand endorsements.3.duringtheperiodofthisinsurance,theinsuredshallathisown expensetakeallreasonableprecautions,includingpayingsufficientattentiontoandputtingintopracticethereasonablerecommendations ofthecompany,prudentlyselectingtheworkmenandemployeesandcomplyi ngwithallstatutoryregulationsandsafetyoperationprocedures.4.intheeventofanyoccurrencewhichgivesormightgiverisetoa claimunderthispolicy,theinsuredorhisrepresentativeshall:4.1notifythecompanyimmediatelyandwithinseven(7)daysoranyfurtherperiodasmaybeagreedbythecompanyinwriting,furnishawrittenreporttoindicatethecourse,probablereasonandextentoflos sordamage;4.2takeallnecessarymeasurestoavoidaggravationofthelossor damageandminimizeittotheleastextent;4.3preservethespotaffectedanddefectivepartsbeforean inspectioniscarriedoutbyarepresentativeorsurveyorfromthe company;4.4furnishallsuchinformationanddocumentaryevidenceasthe companymayrequireforsupportingtheclaim.vi.generalconditions1.policyeffect thedueobservanceandfulfilmentofthetermsandconditionsofthis policyinsofarastheyrelatetoanythingtobedoneorcompliedwithbytheinsuredshallbeaconditionprecedenttoanyliabilityofthecompan yunderthispolicy.2.policyvoidancethispolicyshallbevoidableintheeventofmisrepresentation,misdescriptionornon-disclosuremadebytheinsuredorhisrepresentativeinanymaterialparticularinrespectofthisinsurance.3.policyterminationunlessitscontinuancebeadmittedbythecompanyinwriting,thispolicyshallbeautomaticallyterminatedif:3.1theinsurableinterestoftheinsuredislost;3.2theriskoflossordamageisincreased.afterterminationofthepolicy,thepremiumshallberefundedtotheinsuredcalculatedonproratadailybasisfortheperiodfromthedateofterminationtothedateofexpiry.4.policycancellationthispolicymaybecanceledatanytimeattherequestoftheinsured inwritingorattheoptionofthecompanybygivingafifteen(15)days priornoticetotheinsured.intheformercasethecompanyshallretaina premiumcalculatedonshorttermratebasisforthetimethepolicyhas beeninforcewhileinthelattercasesuchpremiumshallbecalculatedon proratadailybasis.5.forfeitofbenefitiftheclaimisinanyrespectfraudulent,orifanyfraudulentmeans ordevicesareusedbytheinsuredorhisrepresentativetoobtainany benefitunderthispolicyorifanylossordamageisoccasionedbytheintentionalactorintheconnivanceoftheinsuredorhisrepresentativ e,theninanyofthesecases,alltherightsandbenefitsoftheinsured underthispolicyshallbeforfeited,andallconsequentlossesarising therefromincludingtheamountofclaimpaidbythecompanyshallbeindemnifiedbytheinsured.6.reasonableinspection therepresentativeofthecompanyshallatanysuitabletimebe entitledtoattendthesiteandinspectorexaminetheriskexplosureof thepropertyinsured.forthispurpose,theinsuredshallprovidefullassistanceandalldetailsandinformationrequiredbythecompanyasma ybenecessaryfortheassessmentoftherisk.theabovementioned inspectionorexaminationshallinnocircumstancesbeheldasany admissiontotheinsuredbythecompany.7.doubleinsuranceshouldanyloss,damage,expensesorliabilityrecoverableunderthe policybealsocoveredbyanyotherinsurance,thecompanyshallonlybeliabletopayorcontributehisproportionoftheclaimirrespectiveast owhethertheotherinsuranceisarrangedbytheinsuredorothersonhisbehalf,orwhetheranyindemnificationisobtainableundersuchotherinsurance.8.subrogation whereathirdpartyshallbeheldresponsibleforthelossordamagecoveredunderthispolicy,theinsuredshall,whetherbeingindemnifie dbythecompanyornot,takeallnecessarymeasurestoenforceorreservetherightofrecoveryagainstsuchthirdparty,anduponbeingindemnifiedb ythecompany,subrogatetothecompanyalltherightofrecovery,transfe rallnecessarydocumentstoandassistthecompanyinpursuingrecovery fromtheresponsibleparty.9.dispute alldisputesunderthisinsurancearisingbetweentheinsuredandthe companyshallbesettledthroughfriendlynegotiations.wherethetwopartiesfailtoreachanagreementafternegotiations,suchdisputesha llbesubmittedtoarbitrationortocourtforlegalactions.unlessotherwiseagreed,sucharbitrationorlegalactionshallbecarriedout intheplacewherethedefendantisdomiciled.vii.specialprovisionsthefollowingprovisionsshallbeappliedtoallpartsofthispolicyandshalloverridetheothertermsandconditionsofthispolicyifanyconflictarises.propertyinsurancepolicypolicyno.:whereastheinsurednamedinthescheduleheretohasmadetothe______insurancecompany(hereinaftercalled""thecompany"")awritt enproposalwhichtogetherwithanyotherstatementsmadebytheinsuredfo rthepurposeofthispolicyisdeemedtobeincorporatedhereinandhaspaidtothecompanythepremiumstatedintheschedule. nowthispolicyofinsurancewitnessesthatsubjecttothetermsandconditionscontainedhereinorendorsedhereonthecompanyshallindem nifytheinsuredforthelossordamagesustainedduringtheperiodof insurancestatedinthescheduleinthemannerandtotheextent hereinafterprovided.bythe________insurancecompany_________________________authorisedsignaturedateofissue:placeofissue:schedulepolicyno.:andaddressoftheinsured1.1theinsured:1.2address:2.locationofthepropertyinsured:3.natureoftrade:4.insureditemsandsumsinsured: insureditemssumsinsured4.1propertyinsured4.1.1building(s)(includingdecoration): 4.1.2machineryandequipment:4.1.3furnitureandfixture:(includingofficeequipmentandsupplies) 4.1.4stock:4.1.5others:4.2additionalexpenses:4.2.1removalofdebrisfees:4.2.2fireextinguishingexpenses:4.2.3professionalfees:4.2.4otherexpenses:totalsuminsured:5.deductible(anyoneaccident):6.periodofinsurance:___months.from00:00of_________to24:00hoursof______7.premiumrate:totalpremium:8.dateofpayment:9.jurisdiction: thispolicyisgovernedbylawofthepeoplesrepublicofchina.10.specialprovisions: propertyinsurancepolicysschedule_________insurancecompany。
1. Establishment of Joint Venture1.1.1 law and regulations1.Chinese-foreign equity joint ventures (hereinafter referred to as joint ventures)established within Chinese territory upon approval in accordance with the Law on Chinese-Foreign Joint ventures are Chinese legal persons, who shall be governed and protected by Chinese law.2.Joint ventures established within Chinese territory shall be able to promote thedevelopment of the economy and the enhancement of the science and technology of China and facilitate China’s socialist modernization.Industries in which the establishment of joint ventures is encouraged, permitted, restricted or prohibited by the State shall be determined in accordance with the provisions of the State in the Regulations on Foreign Investment Guidelines and the Guideline Catalogue of Foreign Investment Industries.3.The establishment of a joint venture in China shall be subject to the examinationand approval by the Ministry of Foreign Trade and Economic Cooperation of the People’s Republic of China ( MOFTEC). After approval, MOFTEC shall be issue a certificate of approval thereof.4.The State Council shall delegate to the people’s governments of the provinces,autonomous regions and municipalities directly under the Central Government or the relevant departments under the State Council the power to examine and approve joint venture which meet the following conditions(1)The total investment of a joint venture is within the amount limited by theauthority as granted by the State council for examination and approval ofinvestment, and the source of capital of the Chinese party has beenascertained; (the total amount of investment is within the limit of the investmentexamination and approval power as stipulated by the State Council, and the source ofcapital of the Chinese parties has been ascertained) and(2)No additional allocation of raw materials by the State is required, and thenational balance in respect of fuel, power, transportation and foreign tradeexport quota is not affected.Joint ventures established in accordance with provisions of the preceding paragraphs shall be reported to the MOFTEC for the record.MOFTEC and the people’s governments of provinces, autonomous regions and municipalities directly under the Central Government authorized by the State Council or the relevant departments under the State Council shall hereinafter be referred to as the examination and approval authority.5.When applying for establishing a joint venture, the Chinese and foreign partiesshall jointly submit the following documents to the examination and approval authority:(1)an application for the establishment of the joint venture;(2)the feasibility study report jointly prepared by the parties to the jointventure;(3)the joint venture agreement, contract and articles of association executedby the duly authorized representatives of the parties to the joint venture;(4)the list of candidates for the chairman, vice-chairman and directors of thejoint venture nominated by the parties to the joint venture; and(5)other documents specified by the examination and approval authority.The documents listed in the preceding paragraphs must be written in Chinese.Documents (2), (3) and (4) may be written simultaneously in a foreign language agreed upon by the parties to the joint venture. Documents written in both languages shall be equally authentic.If any inappropriate is found in the documents submitted, the examination andapproval authority shall require that it be amended within the specified time.6.The examination and approval authority shall, within three months of the receiptof all the documents stipulated in Article 5 of these Regulations, decide whether to approve or not to approve such documents.7.The applicant shall, within one month of the receipt of the certificate of approval,go through the registration procedures with the administrative authority of industry and commerce in accordance with the relevant stipulations of the State.The date on which the business license of a joint venture is issued shall be the date of the establishment of the joint venture.1.2.1 Contract Terms1.In accordance with the Law of the People’s Republic of China onChinese-Foreign Equity Joint Ventures and other relevant Chinese laws and regulations, Shanghai Sun Co. , Ltd. (hereinafter referred to as “ Party A ” ) and Warren Inc. (hereinafter referred to as “Party B”), adhering to the principles of equality and mutual benefit and through friendly consultations, agree to jointly establish an equity joint venture company ( the “JV Company”) in Shanghai, the People’s Republic of China (“China”), and hereby enter into this Equity Joint Venture Contract (“Contract”).2.The name of the JV Company is上海太阳-沃伦有限公司in Chinese andShanghai Sun-Warren Co., Ltd. in English. The legal address of the JV Company is 1705 Dong Yi Road, Shanghai, China.If either Party cease to be a party to the JV Company at any time during the Joint Venture Term, and if at such time any word in any language and/or logo which is the same as or similar to the corporate name and/or logo of that Party appears in any part of the name and/or logo of the JV Company, the other Party shall procure that the JV Company shall forthwith change its name to exclude such word and/or logo from the corporate name within sixty (60) days of that Party ceasing to be a party to the JV Company and shall procure that allstationery, written materials and publications containing any reference to such corporate name and/or logo shall be forthwith destroyed.3.The JV Company shall be a limited liability company. It shall be liable to thefull extent of its assets. The liability of each party to the JV Company shall be limited to the amount it has contributed to the registered capital of the JV Company pursuant to this Contract and, unless otherwise agreed by the parties, neither party shall have any liability to the JV Company in excess of such amount. Neither party shall be jointly and severally liable to any third party for the JV Company’s liabilities and obligations.4.The JV Company shall be a limited liability company. Each Party’s liabilityto the Company shall be limited to the amount of capital contribution subscribed by it. The Parities shall share the profits and bear the risks and losses in proportion to their respective contribution to the registered capital of the JV Company.5.The JV Company is a legal person in China who shall be governed andprotected by Chinese law. All its activities shall comply with the provisions of Chinese laws and regulations.6.In accordance with the Law of the People’s Republic of China on foreigninvestment Enterprises and its implementation rules and other relevant laws and regulations of China, the Parties to this Contract agree to jointly operatea wholly foreign-owned enterprise in Shanghai, China.7.The Company is a legal person in China, which is by nature a whollyforeign-owned enterprise. It shall be governed and protected by Chinese law, and it shall comply with the provisions of the laws and regulations of China in all its activities. It shall be entitled to all preferential treatment accorded by the State and the local government to wholly foreign-owned enterprises.1.3.1 example1. “必须经……审查批准”译为“shall be subject to the examination and approvalby…”.subject to: dependent or conditional upon (以……为条件;取决于……)。
欧洲药典-凡例1.1. GENERAL STATEMENTSThe General Notices apply to all monographs and other texts of the European Pharmacopoeia.总论的内容适用于各论和欧洲药典中的其它章节。
The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatory States of the European Pharmacopoeia Convention. In case of doubt or dispute, the English and French versions are alone authoritative.欧洲药典以英语和法语形式发行,欧洲药典委员会的签署国可将药典内容译成其它语言,但若发生争议,应以英语和法语版为权威。
In the texts of the European Pharmacopoeia, the word "Pharmacopoeia" without qualification means the European Pharmacopoeia. The official abbreviation Ph. Eur. may be used to indicate the European Pharmacopoeia.在欧洲药典中,如无特殊规定,“药典”是指欧洲药典,缩写Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the article complies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using the monograph title and reference number in italics.文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各论的要求。
摘要如今,中国企业进入国外市场呈现上升趋势。
特别是中国全面入世之后,很多企业已经将公司简介翻译成英文。
然而,通过一定数量的观察研究发现,多数公司译文质量差强人意。
鳖脚的翻译有损公司的形象,更有可能导致公司经济方面的损失。
本文以韦努蒂提出的归化异化理论为框架,通过对几个有代表性的公司简介英译的分析,阐述了如何适当地运用归化和异化理论来解决公司简介英译中的问题。
公司简介翻译的首要目的是为了传递信息,更多考虑如何使译文传递的信息便于读者理解和接受,如何最有效地实现译文预期的功能和目的,原文的形式和内容往往要服从于译文的需要,服从于文本的交际功能。
由此可见,公司简介翻译的主要策略为归化。
当然,异化的策略也是不可或缺的,例如在词汇层面上有时异化是很好的解决办法。
同时,翻译不仅仅是一个语言层面的翻译过程,翻译时译者要根据客户或委托人的要求,结合翻译的目的和译文读者的接受能力,从原作所提供的多源信息中进行选择性的翻译。
关键词:公司简介英译;归化;异化;翻译策略ABSTRACTToday, an increasing number of Chinese businesses are entering foreign markets. Especially with China‟s full access to WTO, many of these companies have their company profiles translated into English to facilitate the advertising of their goods or services in a foreign market. An examination of these translations has revealed the quality of translations leaves much to be desired. Poor translations can damage the image of a company at best and result in adverse financial consequences at worst.The present paper applies Venuti‟s Domestication and Foreignization as the theoretic framework. With analyzing several representative company profile C-E translations, this thesis tries to discuss how to resolve the problems in company profile translation by proper use of Domestication and Foreignization. Company profile translation mainly aims to offer information, so the apprehension of target readers and acceptability of translated versions should be put at the top place. Domestication is, therefore, an appropriate strategy in business translation, but it dose not always work. Because in some cases, foreignization is more effective, such as in lexical level. Besides, translation is not merely a linguistic process. Guided by the translation brief and taking into account of the translation purpose and the acceptability of the target readers, the translator selects certain items from the source-language.Keywords:company profile translation; domestication; foreignization; translation strategyContents1. Introduction (4)1.1 General introduction. (4)1.2 Research problems. (5)2. Company Profile Translation (6)2.1 Characteristics of Company Profile (6)2.1.1 Clearness (6)2.1.2 Conciseness (7)2.1.3 Preciseness (7)2.1.4 Summary (8)2.2 Criteria of Company Profile Translation (8)2.2.1 Properties of Company Profile Translation (8)2.2.2 Principles for Company Profile Translation (8)2.2.3 Summary (11)3. Domestication and Foreignization (12)3.1 General View on Domestication and Foreignization (12)3.2 Domestication (12)3.3 Foreignization (13)4. The Application of Domestication and Foreignization in C-E Company Profile Translation (15)4.1 The existing problems in company profile translation (15)4.2 Sample analysis of C-E company profile translation (15)4.2.1 Sample analysis 1 (15)4.2.1.1 C-E company profile of Zhongtian Information Technology Co., Ltd (15)4.2.1.2 Existing problems on textual level and revision strategies (16)4.2.2 Sample analysis 2 (17)4.2.2.1 C-E company profile translation of Nice Group and Little Swan Group (17)4.2.2.2 Existing problems in lexical and syntactical level and revision strategies (17)4.2.3 Summary (18)4.3 The Influential Factors of Domestication and Foreignization in Company Profile Translation (18)4.3.1 Cultural Differences (18)4.3.2 Economic Differences (19)5. Conclusion (20)Acknowledgements (21)References (22)1. Introduction1.1 General introductionWith the increasing speed of globalization, the world is becoming smaller and smaller. At the same time China joined in WTO, which makes China be connected more closely to the rest of the world .China‟s intercourses with other countries or regions, especially in business field, are developing rapidly. As a result of that, business translation, a kind of media or tool communication, plays more and more important role in economic area and draws more attention as well as arouses more debates on this topic.Business translation is not only a word-translation activity but also cultural exchanges .The choice of domestication or foreignization is the most important approach in the process of translation, which always puts translator in embarrassing situation.Domestication and foreignization are two basic translation strategies which provide both linguistic and cultural guidance. They are termed by American translation theorist L.Venuti. According to Venuti, the former one refers to “an ethnocentric reduction of the foreign text to target-language cultural values, bring the author back home,” while the latter one is “an ethnodeviant pressure on those (cultural) values to register the linguistic and cultural difference of the foreign text, sending the r eader abroad.”[1]20. Generally speaking, domestication designates the type of translation in which a transparent, fluent style is adopted to minimize the strangeness of the foreign text for target language readers, while foreignization means a target text is produced which deliberately breaks target conventions by retaining something of the foreignness of the original [2]59.Business translation belongs to pragmatic translation and has its own characteristics .Business translation mainly aims to offer information, so the apprehension of target readers and acceptability of translated versions should be put at the top place. Domestication is, therefore, an appropriate strategy in business translation, but it dose not always work. Because in some cases, foreignization is more effective .The research on domestication and foreignization has aroused hot debates; unfortunately, most of them are only focused on linguistic level until recent years when cultural study becomes a hot topic.1.2 Research problems.The present dissertation seeks to address the following research questions:1)Which type of text does the Company Profile Translation belong to?2) What are the problems existed in Company Profile Translation?3) How to resolve these problems by applying domestication and foreignization?2. Company Profile Translation2.1 Characteristics of Company ProfileCompany profile is common English adapted to specific business purposes. Generally speaking, business texts fall into the category of formal style. Business texts commonly serve as a media or tool to the receptors to understand all the information or expressions of the senders. A good business text should be clear and correct enough to arouse no misunderstanding or confusion. As a means of communication, the words used in company profile translation are quite different from those in general English. Due to the particularity of business activities, any negligence may cause big losses in money or in time. Every word, therefore, should be used carefully. Thus in terms of characteristics of company profile, the following points should be paid attention to:2.1.1 ClearnessClearness is the soul of company profile. Clearness means one meaning only, that is, there is no ambiguity or misunderstanding. A business report, a contract, an order, or even a note, should be clear enough to make readers understand well. Ambiguous words, phrases and sentence structures should all be avoided.Clearness requires that the information and meanings be expressed in a simple and direct way. The most proper business language is as such that the readers can understand the meaning immediately. Direct rather than indirect expressions are suitable in business texts, because direct expressions are clearer than indirect expressions, and the former are easier than the latter, thus less misunderstanding or confusion may appear.For example:We would like to know whether you would allow us to extend the time of shipment for 20 days and if you would be so kind as to allow us to do so, kindly give us your reply by fax without delay.It is difficult for readers to grasp the idea because it is too lengthy a sentence expressed in such a tortuous way. It can be rewritten as:Please reply by fax immediately if you will allow us to delay the shipmentuntil April 21.如果同意我方把交货时间延期至4月21日,请速回电。
imdrf标准操作程序IMDRF/MC/N2FINAL:2020 (Edition 6)FINAL __TTitle:IMDRF Standard Operating ProceduresAuthoring Group: IMDRF Management CommitteeDate:25 September 2020Dr Choong May Ling, Mimi, IMDRF ChairThis document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum. Copyright © 2020 by the International Medical Device Regulators Forum.Table of Contents1.0Introduction . 32.0IMDRFMembership (3)2.1ManagementCommittee (3)2.2OfficialObservers (4)2.3InvitedObservers (5)2.4Regional HarmonizationInitiatives (6)2.5mittee Membership (7)2.6Working GroupMembership (7)3.0Development of TechnicalDocuments (8)3.1GeneralPrinciples (9)3.2Stage 1 – Assignment of WorkItems (9)3.3Stage 2 – DocumentDevelopment (11)3.4Stage 3 – Advancement from Working Draft to Proposed Document (12)3.5Stage 4 – Consultation on ProposedDocuments (12)3.6Stage 5 – Advancement from Proposed Document to Final Document (13)3.7Stage 6 –Publication (14)4.Development of InformationDocuments (15)5.Document StatusDesignation (15)5.1Location of DesignationCode (15)5.2Working Drafts(WD) (16)5.3Proposed Documents(PD) (16)5.4FinalDocument (16)6.0Review and Revision of IMDRFDocuments (17)6.1Maintenance of IMDRFDocuments (18)6.2IMDRF Secretariat and IMDRF Webmasterresponsibilities (18)7.0Management and Maintenance of GHTFDocuments (19)8.0Record-Keeping/ InformationArchives (20)9.0Translation of IMDRF guidance documents (21)10.0IMDRF-Related Presentations andTraining (22)11.0IMDRFLogo (22)__ ....................................................................................................................................23ANNEXA (24)ANNEXB (26)ANNEXC (28)ANNEXD (29)ANNEXE (33)ANNEXF (34)1.0 Introduction This document is intended to describe the basic procedures that the International Medical Device Regulators Forum (IMDRF) follows when revising the membership of the Management Committee, establishing mittees or Working Groups, developing IMDRF Documents or managing documents developed under the Global Harmonization Task Force (GHTF).The Operating Procedures outlined in this document, in conjunction with the Terms of Reference, are designed to be flexible so that should the need arise, the IMDRF can respond to challenges with respect to its objectives in a timely manner. 2.0 IMDRF Membership IMDRF membership criteria, roles, and responsibilities are listed in each of the Sections belowand are also outlined in Annex D.2.1 Management CommitteeThe Management Committee consists of regulatory authorities and is responsible for the oversight and decision making for all IMDRF activities.Management Committee members are voting members and are expected to attend all IMDRF Management Committee meetings which are held face to face or by teleconference as well as to ensure regular contribution to IMDRF activities and participate in at least 2/3 of the IMDRF Working Groups.Management Committee members have two (2) representatives per delegation and these representatives need to be knowledgeable on IMDRF matters.It is expected that these representatives would consistently attend subsequent IMDRF meetings and that any changes to representatives would require notification to the IMDRF Management Committee chair.In reviewing application requests for membership, the Management Committee will consider whether the regulatory authority has met each of the following requirements, including having: been a regional influence, participated in all IMDRF MC meetings (including teleconferences) for the last two (2) consecutive years, participated in a majority of Working Groups as an Official Observer for the last two (2) consecutive years, providing active contribution, and been an Official Observer forat least the last two (2) consecutive years prior to the application for membership, and sufficient capacity to chair the MC and provide the Secretariat for a year, including hosting two (2) face to face meetings and two (2) scheduled teleconferences.Having been an Official Observer for the last two (2) consecutive years prior to the application for membership, while being an essential precondition for Management Committee membership, does not give the applicant any automatic presumption of conformity with the other criteria listed above.Applications to e a Management Committee member are to be made in writing by pleting the application form (located on the IMDRF website) and sending it to the IMDRF Chair.All applications must be submitted at least two (2) months before the next management mittee meeting for consideration.The application(s) will then be reviewed by the Management Committee at the next Management Committee meeting. The Management Committee will ask the applicant to provide a presentation during that meeting. Any new Management Committee members will be approved with the unanimous agreement of existing Management Committee members.The membership of the Management Committee will be published on the IMDRF website.2.2 Official Observers Official Observers consist of Regulatory Authorities and the World Health Organization (WHO) and participate in the oversight of all IMDRF activities, but do not participate in the decision making process.Official Observers will be expected to attend all Management Committee meetings which are held face to face or by teleconference as well as to participate in IMDRF Working groups.Official Observers will be expected to maintain the confidentiality of the “closed” Management Committee meetings per the Terms of Reference document.When a discussion or portion of a Management Committee meeting is designated as “closed” Official Observers may attend.Official Observers do not participate in the decision making process. As with full members, Official Observers may have two (2) consistent representatives per delegation and these representatives need to be knowledgeable on IMDRF matters.In reviewing application requests to e an Official Observer, the Management Committee will consider whether the applicant has met each of the following requirements: being a Regulatory Authority, operating a mature or maturing system for medical device regulation which should include:o established laws and regulations for medical devices buildingsubstantially on GHTF and IMDRF foundations and principles, o proper petencies for effective implementati...。
AbstractThis article from or had the item concept and the characteristic and so on basic content has carried on the analysis, has analyzed either has the item disclosure form, how the enterprise to or has item accountant to process the existence the question as well as to consummate the enterprise to or has item accountant to process and so on aspects to conduct some related research and the analysis. Should strengthen from our country Government Department concerned to either has item accountant to deal with the issue the research and the enterprise finance and accounting personnel should also enhance unceasingly to or has item accountant aspects and so on question theory level of understanding and practice operation ability proposed some rationalization proposal. Or has the item to take one kind of latency immediate influence enterprise's continually management and to develop, therefore we must treat processing earnestly.1 Liabilities and provisions1.1 Definition of a liabilityA liability is defined by the IASB Framework as a present obligation arising as a result of a past transaction or event. The settlement of a liability will result in an outflow of resources or economic benefit, such as the payment of cash.The main elements in this definition are as follows.Obligation. The entity has an obligation that has arisen from an event or transaction in the past. This is often a legal obligation, such as the contractual obligation to pay a supplier for the purchase of goods or services. An obligation might be a constructive obligation where the obligation arises out of an established past practice or a valid expectation or declared policy of the business entity - such as a promise by the business entity to refund the price of goods to customers if the customers are dissatisfied.The obligation exists now. The obligation is a present obligation.It is not an obligation that will or might occur in the future. The payment will occur in the future, but the obligation to pay already exists. Outflow of economic benefits. The obligation will result in an outflow of economic benefits at some time in the future. This will normally take the form of payments in cash, or the transfer of an asset other than cash.Examples of liabilities are loans from a bank, bonds issued by a company, trade payables, tax payable to the government, and accruedexpenses.1.2 Accounting treatment of liabilitiesIAS 1 states that liabilities should normally be shown in the statement of financial position as either:Current liabilities (payable within 12 months or within the normal trading cycle of the entity)Non-current liabilities: these are all liabilities that are not current.1.3 ProvisionsIAS 37 Provisions, contingent assets and contingent liabilities defines a provision as ‘a liability of uncertain timing or amount’. A provision is therefore a type of liability, and meets the definition of a liability.IAS 37 explains how provisions differ from other liabilities.With a provision, there is uncertainty about the timing or the amount of the future payment that will be required to settle the obligation. With a liability such as a trade payable or a bank loan, the liability is for a certain amount and it is also certain (or fairly certain) when settlement (= payment) will be required.An accrual is a liability for goods or services payable in the future where the actual amount of the payment is usually not yet known (because there has not yet been an invoice from the supplier). For example, accrued electricity charges are an accrued expense for electricity based on an estimate of the amount of the next electricity bill. However, the uncertainty with an accrual is much less than the uncertainty for a provision.1.4 Accounting for provisionsWhen a provision is created:The amount of the provision is recognised as an expense in the income statement for the periodA liability is created in the statement of financial position for the amount of the provision.A provision should be shown in the statement of financial position. It is shown as a liability, but separate from other liabilities. (Whereas accruals are often included with trade payables as a single figure in the statement of financial position, a provision must be shown on a line of its own.)Provisions should also be shown in the statement of financial position as either a current liability or a non-current liability, depending on when settlement of the obligation is expected to occur.1.5 Increasing a provisionIn some cases, a long-term provision that was created in an earlier year might be increased at the end of a subsequent year, when the amount of the obligation is re- assessed. When a provision is increased: The increase in the amount of the provision is recognised as an expense in the income statement for the period, andThe provision in the statement of financial position is increased to its revised, higher amount.1.6 Reducing a provisionSimilarly, in some cases a long-term provision that was created in an earlier year might be reduced at the end of a subsequent year. Whena provision is reduced:The reduction in the amount of the provision reduces expenses in the income statement for the period, andThe provision in the statement of financial position is reduced to its revised, lower amount.1.7 Recognition and measurement of provisionsIn the past, some companies were suspected of using provisions to manipulate their reported annual profits (an example of ‘window dressing’ of financial statements). A company might create a provision in one year, which would have the effect of reducing profits in that year. The next year, the provision would then be used or reduced, which would have the effect of reducing costs and increasing profits for that year. Provisions could therefore be used to move profits and losses from one year to another.IAS 37 seeks to prevent the use of provisions to manipulate or ‘window dress’ financial statements.Recognising provisionsIAS 37 states that a provision should only be recognised if the following conditions are met:The entity has a present obligation arising out of a past event or transaction.It is probable that an outflow of economic resources (such as cash payments) will be required to settle the obligation. ‘Probable’ means more likely than not.Although the amount of the obligation is uncertain, there is a reliable estimate of what it will be. This estimate might be based on a range of probable outcomes.Examples of events or transactions that might result in a provision are:An obligation to settle a legal dispute, where the legal case has already been lost but the amount of the settlement has not yet been decidedAn obligation to pay clean-up costs for causing environmental damage An obligation to pay decommissioning costs to take an asset out of service at the end of its useful life (for example a provision for decommissioning a nuclear reactor).IAS 37 specifically deals with certain situations where provisions may or may not be created.A provision cannot be made for future operating losses. There is no present obligation arising out of past events; therefore a provision cannot be made. If a company expects to make an operating loss in the next financial year, it cannot make a provision and take the loss in the current year instead.A provision can be made for future restructuring costs, when an entity closes down a part of its business operations, or re-organises its management structure, or decides to relocate operations to another country or region. However, a provision may only be made if there is a detailed formal plan for the restructuring and there is an expectation that the restructuring will take place. If the reorganisation plan has been agreed but has not been formally announced and employees have not yet been told, a provision cannot be made.Measurement of provisionsThe amount of a provision should be the best estimate of the amount (before tax) that will be required to settle the obligation.If the obligation is for a single transaction or event, the most likely amount of the obligation should be used.If there are obligations for many similar transactions, an expected value should be calculated for the obligations. An example is a provision for future costs that will be incurred to honour warranty obligations.2 Contingent liabilities and assets2.1 Definition of contingent liabilities and contingent assets‘Contingent’ means ‘dependent on something happening’.A contingent liability is a liability that will only occur if something happens in the future. It can be defined as a possible obligation arising from an event that has already happened, and whose existence will only be confirmed by the occurrence or non-occurrence of an uncertain future event. This uncertain future event should be not wholly within the control of the company to make it happen.A contingent asset is an asset that will arise (such as cash income) or a benefit that will occur only if something happens in the future. It is similar to a contingent liability, except that it is a possible benefitrather than a possible obligation.2.2 Contingent liabilities and actual liabilities or provisionsA contingent liability is different from a liability (or provision) because there is doubt about whether the obligation will lead to an outflow of economic benefits. The liability is ‘contingent’ (dependent) on something that will happen or will not happen in the future.Examples of contingent liabilities include the following.The outcome of a legal dispute, in which the company might be required to make a large payment to settle the dispute (contingent liability) or might receive a substantial amount of money in settlement (contingent asset). The legal decision has not yet been made; therefore it is too soon to make a provision.The possibility of having to pay a fine to a regulating body for a breach of regulations (contingent liability).The possibility of having to meet an obligation under a guarantee given to a bank on behalf of another company. A contingent liability exists when there is a risk that this other company will fail to repay the loan and the bank will call on the guarantee. The guarantee might therefore be a contingent liability.2.3 Recognising contingent liabilitiesA decision has to be made whether an item is a contingent liability or not.Is the item a contingent liability or an actual liability? For example, should the item be a provision? With a provision, the obligation will probably result in an outflow of economic benefits and a reliable estimate can be made of the amount of the obligation. With a contingent liability:− the obligation is a possible obligation, but not a probable obligation (so that it is less than 50% likely to happen), or− there is an obligation but the outflow of economic benefits is not probable (= less than 50% likely to happen), or− there is an obligation but a reliable estimate of the amount of the obligation cannot be made.Is the item a contingent liability, or is there only a remote possibility that it will happen? If the likelihood that an actual obligation will arise is remote, the item should be ignored altogether, and should not be treated as a contingent liability for the purpose of financial reporting.IAS 37 uses the concept of ‘probable’ to distinguish between actual liabilities (or provisions), contingent liabilities and items to be ignored.2.4 Contingent liabilities: the accounting rulesThe accounting rules for contingent liabilities are provided by IAS 37. The rules are set out below:IAS 37 defines probable as ‘more likely than not’, i.e. more than50% probability.Having decided whether an item is a liability (or provision, which is a form of liability), a contingent liability or a remote possibility, the accounting rules are therefore:Recognise a liability or provision in the financial statements and include in the statement of financial position (and as an expense in profit and loss)Do not recognise a contingent liability in the financial statements and do not include in the statement of financial position (or in profit and loss): instead, give details of the contingent liability in a note to the financial statementsIgnore entirely items where the possibility of an obligation arising is remote.2.5 Contingent assetsThere are similar problems with contingent assets. Is the item a contingent asset or not?Is it a contingent asset, or is it an actual asset? If the future benefit is certain or ‘virtually certain’ it is an actual asset and the item should be ‘recognised’ in the financial statements. It should be included as an actual asset in the statement of financial position.Is it a contingent asset, or is the likelihood that it will happen not sufficiently high to treat it as a contingent asset? If the likelihood of future economic benefits is not strong enough, the item should be ignored for the purpose of financial reporting.For example suppose that a company is in a legal dispute and is claiming $10 million from another company for breach of contract. Should this be treated as an asset, a contingent asset, or ignored?IAS 37 uses the concepts of ‘virtual certainty’, ‘probable’ to distinguish between actual assets, contingent assets and items to be ignored. The rules in IAS37 are as follows:or less than 50% probable, the accounting rules are therefore: Recognise an asset in the financial statements and include in the statement of financial position (and as income in profit and loss) Do not recognise an asset in the financial statements and do not include in the statement of financial position (or in profit and loss): instead, give details of the contingent asset in a note to the financial statementsIgnore entirely items where the possibility of economic benefits arising is less than 50%.2.6 Contingent assets and contingent liabilities: disclosure requirementsWhen an item is reported as a contingent liability or a contingent asset, it is not recorded in the main ledger accounts. The note to the financial statements simply gives a narrative description of the item –including the nature of the item and the uncertainties relating to the amount or the timing of the item.IAS 37 also includes the following requirements:When any disclosures required about a provision, a contingent asset or a contingent liability are not possible, because it is not practicable to provide the information, this fact should be disclosed.In the very rare occasions when disclosure of the information could seriously prejudice the entity in a dispute with another person (about the matter to which the provision or contingent item relates), the required information need not be disclosed. However, the note to the accounts should describe the general nature of the dispute and the reason why the required information has not been disclosed.SummaryIn recent years, developed and modern enterprise system's establishment unceasingly along with our country market economy, the enterprise faces such as the pending action, the unsettled arbitration, the bill discount, the security for loan and so on or has the item to be getting more and more. Under the market economy environment, enterprise's production and operating activities can receive the numerous elements of certainty the influences, thus has produced each kind or has the item.Or has the item to take the special uncertainty item, is the uncertainty accountant's important content. Either has the item to take the special uncertainty item, along with our country socialist market economy development, either has the item to exist generally inenterprise's operative activity, the information as well as operating decisions' influence is also getting bigger and bigger to financial inventory accounting, how to process, the reasonable disclosure correctly or have the item to receive the general investors and the management value more and more.。
EUROPEAN PHARMACOPOEIA 5.0 1.Generalnotices01/2005:101001.1.GENERAL STATEMENTS The General Notices apply to all monographs and other texts of the European Pharmacopoeia.The official texts of the European Pharmacopoeia are published in English and French.Translations in other languages may be prepared by the signatory States of the European Pharmacopoeia Convention.In case of doubt or dispute,the English and French versions are alone authoritative.In the texts of the European Pharmacopoeia,the word “Pharmacopoeia”without qualification means the European Pharmacopoeia.The official abbreviation Ph.Eur.may be used to indicate the European Pharmacopoeia.The use of the title or the subtitle of a monograph implies that the article complies with the requirements of the relevant monograph.Such references to monographs in the texts of the Pharmacopoeia are shown using the monograph title and reference number in italics .A preparation must comply throughout its period of validity;a distinct period of validity and/or specifications for opened or broached containers may be decided by the competent authority.The subject of any other monograph must comply throughout its period of use.The period of validity that is assigned to any given article and the time from which that period is to be calculated are decided by the competent authority in the light of experimental results of stability studies.Unless otherwise indicated in the General Notices or in the monographs,statements in monographs constitute mandatory requirements.General chapters become mandatory when referred to in a monograph,unless such reference is made in a way that indicates that it is not the intention to make the text referred to mandatory but rather to cite it for information.The active ingredients (medicinal substances),excipients (auxiliary substances),pharmaceutical preparations and other articles described in the monographs are intended for human and veterinary use (unless explicitly restricted to one of these uses).An article is not of Pharmacopoeia quality unless it complies with all the requirements stated in the monograph.This does not imply that performance of all the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with the Pharmacopoeia before release of a product.The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived,for example,from validation studies of the manufacturing process and from in-process controls.Parametric release in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Pharmacopoeia.The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based.With the agreement of the competent authority,alternative methods of analysis may be used for control purposes,provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used.In the event of doubt or dispute,the methods of analysis of the Pharmacopoeia are alone authoritative.Certain materials that are the subject of a pharmacopoeial monograph may exist in different grades suitable for different purposes.Unless otherwise indicated in the monograph,the requirements apply to all grades of the material.In some monographs,particularly those on excipients,a list of functionality-related characteristics that are important for the use of the substance may be appended to the monograph for information.Test methods for determination of one or more of these characteristics may be given,also for information.General monographs .Substances and preparations that are the subject of an individual monograph are also required to comply with relevant,applicable general monographs.Cross-references to applicable general monographs are not normally given in individual monographs.General monographs apply to all substances and preparations within the scope of the Definition section of the general monograph,except where a preamble limits the application,for example to substances and preparations that are the subject of a monograph of the Pharmacopoeia.General monographs on dosage forms apply to all preparations of the type defined.The requirements are not necessarily comprehensive for a given specific preparation and requirements additional to those prescribed in the general monograph may be imposed by the competent authority.Conventional terms .The term “competent authority”means the national,supranational or international body or organisation vested with the authority for making decisions concerning the issue in question.It may,for example,be a national pharmacopoeia authority,a licensing authority or an official control laboratory.The expression “unless otherwise justified and authorised”means that the requirements have to be met,unless the competent authority authorises a modification or an exemption where justified in a particular case.Statements containing the word “should”are informative or advisory.In certain monographs or other texts,the terms “suitable”and “appropriate”are used to describe a reagent,micro-organism,test method etc.;if criteria for suitability are not described in the monograph,suitability is demonstrated to the satisfaction of the competent authority.Interchangeable methods .Certain general chapters contain a statement that the text in question is harmonised with the corresponding text of the Japanese Pharmacopoeia and/or the United States Pharmacopeia and that these texts are interchangeable.This implies that if a substance or preparation is found to comply with a requirement using an interchangeable method from one of these pharmacopoeias it complies with the requirements of the European Pharmacopoeia.In the event of doubt or dispute,the text of the European Pharmacopoeia is alone authoritative.01/2005:102001.2.OTHER PROVISIONS APPLYING TO GENERAL CHAPTERS AND MONOGRAPHS Quantities .In tests with numerical limits and assays,the quantity stated to be taken for examination is approximate.The amount actually used,which may deviate by not more than 10per cent from that stated,is accurately weighed or measured and the result is calculated from this exact quantity.In tests where the limit is not numerical,but usually depends upon comparison with the behaviour of a reference in the same conditions,the stated quantity is taken for examination.Reagents are used in the prescribed amounts.Quantities are weighed or measured with an accuracy commensurate with the indicated degree of precision.For weighings,the precision corresponds to plus or minus 5units General Notices (1)apply to all monographs and other texts 51.General notices EUROPEAN PHARMACOPOEIA5.0after the last figure stated(for example,0.25g is to be interpreted as0.245g to0.255g).For the measurement of volumes,if the figure after the decimal point is a zero or ends in a zero(for example,10.0ml or0.50ml),the volume is measured using a pipette,a volumetric flask or a burette,as appropriate;otherwise,a graduated measuring cylinder or a graduated pipette may be used.Volumes stated in microlitres are measured using a micropipette or microsyringe.It is recognised,however,that in certain cases the precision with which quantities are stated does not correspond to the number of significant figures stated in a specified numerical limit.The weighings and measurements are then carried out with a sufficiently improved accuracy.Apparatus and procedures.Volumetric glassware complies with Class A requirements of the appropriate International Standard issued by the International Organisation for Standardisation.Unless otherwise prescribed,analytical procedures are carried out at a temperature between15°C and25°C. Unless otherwise prescribed,comparative tests are carried out using identical tubes of colourless,transparent,neutral glass with a flat base;the volumes of liquid prescribed are for use with tubes having an internal diameter of16mm but tubes with a larger internal diameter may be used provided the volume of liquid used is adjusted(2.1.5).Equal volumes of the liquids to be compared are examined down the vertical axis of the tubes against a white background,or if necessary against a black background.The examination is carried out in diffuse light.Any solvent required in a test or assay in which an indicator is to be used is previously neutralised to the indicator,unless a blank test is prescribed.Water-bath.The term“water-bath”means a bath of boiling water unless water at another temperature is indicated. Other methods of heating may be substituted provided the temperature is near to but not higher than100°C or the indicated temperature.Drying and ignition to constant mass.The terms“dried to constant mass”and“ignited to constant mass”mean that2consecutive weighings do not differ by more than0.5mg, the second weighing following an additional period of drying or of ignition respectively appropriate to the nature and quantity of the residue.Where drying is prescribed using one of the expressions “in a desiccator”or“in vacuo”,it is carried out using the conditions described under2.2.32.Loss on drying.REAGENTSThe proper conduct of the analytical procedures described in the Pharmacopoeia and the reliability of the results depend, in part,upon the quality of the reagents used.The reagents are described in general chapter4.It is assumed that reagents of analytical grade are used;for some reagents,tests to determine suitability are included in the specifications.SOLVENTSWhere the name of the solvent is not stated,the term “solution”implies a solution in water.Where the use of water is specified or implied in the analytical procedures described in the Pharmacopoeia or for the preparation of reagents,water complying with the requirements of the monograph on Purified water(0008)is used,except that for many purposes the requirements for bacterial endotoxins(Purified water in bulk)and microbial contamination(Purified water in containers)are not relevant.The term“distilled water”indicates purified water prepared by distillation.The term“ethanol”without qualification means anhydrous ethanol.The term“alcohol”without qualification means ethanol(96per cent).Other dilutions of ethanol are indicated by the term“ethanol”or“alcohol”followed by a statement of the percentage by volume of ethanol(C2H6O) required.EXPRESSION OF CONTENTIn defining content,the expression“per cent”is used according to circumstances with one of two meanings:—per cent m/m(percentage,mass in mass)expresses the number of grams of substance in100grams of finalproduct,—per cent V/V(percentage,volume in volume)expresses the number of millilitres of substance in100millilitres of final product.The expression“parts per million(ppm)”refers to mass in mass,unless otherwise specified.TEMPERATUREWhere an analytical procedure describes temperature without a figure,the general terms used have the following meaning:—in a deep-freeze:below−15°C,—in a refrigerator:2°C to8°C,—cold or cool:8°C to15°C,—room temperature:15°C to25°C.01/2005:10300 1.3.GENERAL CHAPTERS CONTAINERSMaterials used for containers are described in general chapter3.1.General names used for materials,particularly plastic materials,each cover a range of products varying not only in the properties of the principal constituent but also in the additives used.The test methods and limits for materials depend on the formulation and are therefore applicable only for materials whose formulation is covered by the preamble to the specification.The use of materials with different formulations,and the test methods and limits applied to them,are subject to agreement by the competent authority. The specifications for containers in general chapter3.2 have been developed for general application to containers of the stated category but in view of the wide variety of containers available and possible new developments,the publication of a specification does not exclude the use,in justified circumstances,of containers that comply with other specifications,subject to agreement by the competent authority.Reference may be made within the monographs of the Pharmacopoeia to the definitions and specifications for containers provided in chapter3.2.Containers.The general monographs for pharmaceutical dosage forms may,under the heading Definition/Production,require the use of certain types of container;certain other monographs may, under the heading Storage,indicate the type of container that is recommended for use.6See the information section on general monographs(cover pages)。