欧洲药典中英文翻译 EP8.0干燥失重
欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译
欧洲药典EP8.0-2.6.1无菌检验-sterility中英文翻译2.6.1. STERILITY2.6.1 无菌检查法The test is applied to substances, preparations or articles which, accordingto the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test.本检查方法适用于按照药典要求应当无菌的原料、制剂或其他物质。
但是，如果按照本无菌检查法的结果符合要求，仅表明在该检查条件下未发现微生物污染。
PRECAUTIONS AGAINST MICROBIAL CONTAMINATION微生物污染防范The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed. The precautions taken to avoid contamination are such that they do not affect any micro-organisms which are to be revealed in the test. The working conditions in which the tests are performed are monitored regularly by appropriate sampling of the working area and by carrying out appropriate controls.无菌检测试验应在无菌的条件下进行。
欧洲药典中英文翻译 EP8.0干燥失重
2.2.32. LOSS ON DRYING 干燥失重Loss on drying is the loss of mass expressed as per cent m/m.干燥失重指重量损失，表述为% 重量/重量Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C.方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。
如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。
a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature;“在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature;“真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph;“在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph;“在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph.“在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥If other conditions are prescribed, the procedure to be used is described in full in the monograph.如果需要采用其它条件，则在各论中应进行详细描述。
纯化水英汉对照-欧洲药典8.0
WATER,PURIFIED纯化水H2O M r18.12 DEFINITIONWater for the preparation of medicines other than those that are required to be both sterile and apyrogenic,unless otherwise justified and authorized.定义制药用水不同于其它用水，要求它是无菌的、无热源的，除非另有调整或授权。
Purified water in bulk散装纯化水PRODUCTIONPurified water in bulk is prepared by distillation,by ion exchange,by reverse osmosis or by any other suitable method from water that complies with the regulations on water intended for human consumption laid down by the competent authority.Purified water in bulk is stored and distributed in conditions designed to prevent growth of micro-organisms and to avoid any other contamination.生产：散装纯化水是经合格的当局规定的适宜人类使用的水经蒸馏、离子交换、反渗透膜或其他任何适合的方法制备。
散装纯化水存储和分配于可防止微生物生长和可避免其他任何污染的条件下。
Microbiological monitoring During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored.Appropriate alert and action levels are set so as to detect adverse trends.Under normal conditions,an appropriate action level is a microbial count of100CFU/mL,determined by filtration through a membrane with a nominal pore size not greater than0.45μm,using R2A agar and incubating at30-35°C for not less than5days.The size of the sample is to be chosen in relation to the expected result.微生物监测在生产和其后的存储过程中，采取适当的方式以确保水的微生物数受到足够的控制和监测。
USP 干燥失重法中英文对照
<731>LOSS ON DRYINGThe procedure set forth in this chapter determines the amount of volatile matter of any kind that is driven off under the conditions specified.For substances appearing to contain water as the only volatile constituent, the procedure given in the chapter,Water Determination921,is appropriate,and is specified in the individual monograph.Mix and accurately weigh the substance to be tested,and,unless otherwise directed in the individual monograph,conduct the determination on1to 2g.If the test specimen is in the form of large crystals,reduce the particle size to about2mm by quickly crushing.Tare a glass-stoppered, shallow weighing bottle that has been dried for30minutes under the same conditions to be employed in the determination.Put the test specimen in the bottle,replace the cover,and accurately weigh the bottle and the contents.By gentle,sidewise shaking,distribute the test specimen as evenly as practicable to a depth of about5mm generally,and not more than10mm in the case of bulky materials.Place the loaded bottle in the drying chamber,removing the stopper and leaving it also in the chamber. Dry the test specimen at the temperature and for the time specified in the monograph.[NOTE—The temperature specified in the monograph is to be regarded as being within the range of±2of the stated figure.]Upon opening the chamber,close the bottle promptly,and allow it to come to room temperature in a desiccator before weighing.If the substance melts at a lower temperature than that specified for the determination of Loss on drying,maintain the bottle with its contents for1to2hours at a temperature5to10below the melting temperature, then dry at the specified temperature.Where the specimen under test is Capsules,use a portion of the mixed contents of not fewer than4capsules.Where the specimen under test is Tablets,use powder from not fewer than 4tablets ground to a fine powder.Where the individual monograph directs that loss on drying be determined by thermogravimetric analysis,a sensitive electrobalance is to be used.Where drying in vacuum over a desiccant is directed in the individual monograph,a vacuum desiccator or a vacuum drying pistol,or other suitable vacuum drying apparatus,is to be used.Where drying in a desiccator is specified,exercise particular care to ensure that the desiccant is kept fully effective by frequent replacement.Where drying in a capillary-stoppered bottle*in vacuum is directed in the individual monograph,use a bottle or tube fitted with a stopper having a225±25µm diameter capillary,and maintain the heating chamber at a pressure of5mm or less of mercury.At the end of the heating period, admit dry air to the heating chamber,remove the bottle,and with the capillary stopper still in place allow it to cool in a desiccator before weighing.本章中给出的方法阐述了在特定的条件下物质中的挥发性成分的测定。
色氨酸欧洲药典EP8.0
⾊氨酸欧洲药典EP8.0Tryptophan EUROPEAN PHARMACOPOEIA8.0Reference solution .Dissolve 25.0mg of trypsin BRP in 0.001M hydrochloric acid and dilute to 25.0mL with the same acid.Store the solutions at 0-5°C.Warm 1mL of each solution to about 25°C over 15min and use 50µL of each solution for each titration.Carry out the titration in an atmosphere of nitrogen.Transfer 10.0mL of 0.0015M borate buffer solution pH 8.0R to the reaction vessel and,while stirring,add 1.0mL of a freshly prepared 6.86g/L solution of benzoylarginine ethyl ester hydrochloride R .When the temperature is steady at 25.0±0.1°C (after about 5min)adjust to pH 8.0exactly with 0.1M sodium hydroxide .Add 50µL of the test solution and start a timer.Maintain at pH 8.0by the addition of 0.1M sodium hydroxide ,the tip of the microburette being immersed in the solution;note the volume added every 30s.Follow the reaction for 8min.Calculate the volume of 0.1M sodium hydroxide used per second.Carry out a titration in the same manner using the reference solution and calculate the volume of 0.1M sodium hydroxide used per second.Calculate the activity in microkatals per milligram using the following expression:m =mass of the substance to be examined,in milligrams;m ′=mass of trypsin BRP ,in milligrams;V =volume of 0.1M sodium hydroxide used per second by the test solution;V ′=volume of 0.1M sodium hydroxide used per second by the reference solution;A=activity of trypsin BRP ,in microkatals per milligram.STORAGEIn an airtight container,protected from light,at a temperature of 2°C to 8°C.LABELLING The label states:–the activity in microkatals per milligram;–for the amorphous substance,that it is hygroscopic.01/2009:1272corrected 7.0TRYPTOPHANTryptophanumC 11H 12N 2O 2M r 204.2[73-22-3]DEFINITION(S )-2-Amino-3-(1H -indol-3-yl)propanoic acid.Content :98.5per cent to 101.0per cent (dried substance).CHARACTERSAppearance :white or almost white,crystalline or amorphous powder.Solubility :sparingly soluble in water,slightly soluble inethanol (96per cent).It dissolves in dilute solutions of mineral acids and alkali hydroxides.IDENTIFICATIONFirst identification:A,B.Second identification:A,C,D.A.Speci?c optical rotation (see Tests).B.Infrared absorption spectrophotometry (2.2.24).Preparation :discs.Comparison :tryptophan CRS .C.Examine the chromatograms obtained in the test for ninhydrin-positive substances.Results :the principal spot in the chromatogram obtained with test solution (b)is similar in position,colour and size to the principal spot in the chromatogram obtained with reference solution (a).D.Dissolve about 20mg in 10mL of water R .Add 5mL of dimethylaminobenzaldehyde solution R6and 2mL of hydrochloric acid R1.Heat on a water-bath.A purple-blue colour develops.TESTSAppearance of solution .The solution is clear (2.2.1)and not more intensely coloured than reference solution BY6(2.2.2,Method II ).Dissolve 0.1g in 1M hydrochloric acid and dilute to 10mL with the same acid.Speci?c optical rotation (2.2.7):?30.0to ?33.0(dried substance).Dissolve 0.25g in water R ,heating on a water-bath if necessary,and dilute to 25.0mL with the same solvent.Ninhydrin-positive substances .Thin-layer chromatography (2.2.27).Solvent mixture :glacial acetic acid R ,water R (50:50V/V ).Test solution (a).Dissolve 0.10g of the substance to be examined in the solvent mixture and dilute to 10mL with the solvent mixture.Test solution (b).Dilute 1mL of test solution (a)to 50mL with the solvent mixture.Reference solution (a).Dissolve 10mg of tryptophan CRS in the solvent mixture and dilute to 50mL with the solvent mixture. Reference solution (b).Dilute 5mL of test solution (b)to 20mL with the solvent mixture.Reference solution (c).Dissolve 10mg of tryptophan CRS and 10mg of tyrosine CRS in the solvent mixture and dilute to25mL with the solvent mixture.Plate :TLC silica gel plate R .Mobile phase :glacial acetic acid R ,water R ,butanol R (20:20:60V/V/V ).Application :5µL.Development :over a path of 15cm.Drying :in air.Detection :spray with ninhydrin solution R and heat at 100-105°C for 15min.System suitability :reference solution (c):–the chromatogram shows 2clearly separated spots.Limit :test solution (a):–any impurity :any spot,apart from the principal spot,is not more intense than the principal spot in the chromatogram obtained with reference solution (b)(0.5per cent).Impurity A and other related substances .Liquidchromatography (2.2.29).Prepare the standard,test and reference solutions immediately before use.Buffer solution pH 2.3.Dissolve 3.90g of sodium dihydrogen phosphate R in 1000mL of water R .Add about 700mL of a2.9g/L solution of phosphoric acid R and adjust to pH 2.3with the same acid solution.Solvent mixture :acetonitrile R ,water R (10:90V/V ).3490See the information section on general monographs (cover pages)EUROPEAN PHARMACOPOEIA 8.0TryptophanStandard solution .Dissolve 10.0mg of N-acetyltryptophan R in the solvent mixture and dilute to 100.0mL with the solvent mixture.Dilute 2.0mL of this solution to 100.0mL with the solvent mixture.Test solution (a).Dissolve 0.10g of the substance to be examined in the solvent mixture and dilute to 10.0mL with the solvent mixture.Test solution (b).Dissolve 0.10g of the substance to beexamined in the standard solution and dilute to 10.0mL with the standard solution.Reference solution (a).Dissolve the contents of a vial of 1,1′-ethylidenebistryptophan CRS (impurity A)in 1.0mL of the solvent mixture.Reference solution (b).Dissolve the contents of a vial of 1,1′-ethylidenebistryptophan CRS (impurity A)in 1.0mL of the standard solution.Reference solution (c).Dilute 0.5mL of reference solution (a)to 5.0mL with the solvent mixture.Column :–size :l =0.25m,?=4.6mm;–stationary phase :octadecylsilyl silica gel for chromatography R (5µm);–temperature :40°C.Mobile phase :–mobile phase A :acetonitrile R ,buffer solution pH 2.3(115:885V/V );–mobile phase B :acetonitrile R ,buffer solution pH 2.3(350:650V/V );Time (min)Mobile phase A (per cent V/V )Mobile phase B (per cent V/V )0-1010010-45100→00→10045-65100Flow rate :0.7mL/min.Detection :spectrophotometer at 220nm.Injection :20µL of test solutions (a)and (b)and reference solutions (b)and (c).Retention time :tryptophan =about 8min;N -acetyltrypto-phan =about 29min;impurity A =about 34min.System suitability :–resolution :minimum 8.0between the peaks due toN -acetyltryptophan and impurity A in the chromatogram obtained with reference solution (b);if necessary,adjust the time programme for the elution gradient (an increase in the duration of elution with mobile phase A produces longer retention times and a better resolution);–signal-to-noise ratio :minimum 15for the principal peak in the chromatogram obtained with reference solution (c);–symmetryfactor :maximum 3.5for the peak due toimpurity A in the chromatogram obtained with reference solution (b).–in the chromatogram obtained with test solution (a)there is no peak with the same retention time as N -acetyltryptophan (in such case correct the area of the N -acetyltryptophan peak).Limits :test solution (b):–impurity A :not more than 0.5times the area of the principal peak in the chromatogram obtained with reference solution (c) (10ppm);–sum of impurities with a retention time less than that of tryptophan :not more than 0.6times the area of the peak due to N -acetyltryptophan in the chromatogram obtained with reference solution (b)(100ppm);–sum of impurities with a retention time greater than that of tryptophan and up to 1.8times the retention time of N-acetyltryptophan :not more than 1.9times the area of the peak due to N -acetyltryptophan in the chromatogram obtained with reference solution (b)(300ppm);–disregard limit:0.02times the area of the peak due to N -acetyltryptophan in the chromatogram obtained with reference solution (b);disregard the peak due to N -acetyltryptophan.Chlorides (2.4.4):maximum 200ppm.Dissolve 0.25g in 3mL of dilute nitric acid R and dilute to 15mL with water R .The solution,without any further addition of nitric acid,complies with the test.Sulfates (2.4.13):maximum 300ppm.Dissolve 0.5g in a mixture of 5volumes of dilute hydrochloric acid R and 25volumes of distilled water R ,and dilute to 15mL with the same mixture of solvents.Ammonium (2.4.1,Method B ):maximum 200ppm,determined on 0.10g.Prepare the standard using 0.2mL of ammonium standard solution (100ppm NH 4)R .Iron (2.4.9):maximum 20ppm.In a separating funnel,dissolve 0.50g in 10mL of dilute hydrochloric acid R .Shake with 3quantities,each of 10mL,of methyl isobutyl ketone R1,shaking for 3min each time.To the combined organic layers add 10mL of water R and shake for3min.Examine the aqueous layer.Heavy metals (2.4.8):maximum 10ppm.2.0g complies with test D.Prepare the reference solution using 2mL of lead standard solution (10ppm Pb)R .Loss on drying (2.2.32):maximum 0.5per cent,determined on 1.000g by drying in an oven at 105°C.Sulfated ash (2.4.14):maximum 0.1per cent,determined on 1.0g.ASSAYDissolve 0.150g in 3mL of anhydrous formic acid R .Add 30mL of anhydrous acetic acid R .Titrate with 0.1M perchloric acid ,using 0.1mL of naphtholbenzein solution R as indicator.1mL of 0.1M perchloric acid is equivalent to 20.42mg of C 11H 12N 2O 2.STORAGEProtected from light.IMPURITIESA.3,3′-[ethylidenebis(1H -indole-1,3-diyl)]bis[(2S )-2-aminopropanoic]acid (1,1′-ethylidenebistryptophan),B.(S )-2-amino-3-[(3RS )-3-hydroxy-2-oxo-2,3-dihydro-1H -indol-3-yl]propanoic acid (dioxyindolylalanine), General Notices (1)apply to all monographs and other texts3491Tuberculin for human use,old EUROPEAN PHARMACOPOEIA8.0C.R=H:(S)-2-amino-4-(2-aminophenyl)-4-oxobutanoicacid(kynurenine),E.R=CHO:(S)-2-amino-4-[2-(formylamino)phenyl]-4-oxobutanoic acid(N-formylkynurenine),D.(S)-2-amino-3-(5-hydroxy-1H-indol-3-yl)propanoic acid(5-hydroxytryptophan),F.(S)-2-amino-3-(phenylamino)propanoic acid(3-phenylaminoalanine),G.(S)-2-amino-3-(2-hydroxy-1H-indol-3-yl)propanoic acid(2-hydroxytryptophan),H.R=H:(3RS)-1,2,3,4-tetrahydro-9H-β-carboline-3-carboxylic acid,I.R=CH3:1-methyl-1,2,3,4-tetrahydro-9H-β-carboline-3-carboxylicacid,J.R=CHOH-CH2-OH:(S)-2-amino-3-[2-[2,3-dihydroxy-1-(1H-indol-3-yl)propyl]-1H-indol-3-yl]propanoic acid,K.R=H:(S)-2-amino-3-[2-(1H-indol-3-ylmethyl)-1H-indol-3-yl]propanoicacid,L.1-(1H-indol-3-ylmethyl)-1,2,3,4-tetrahydro-9H-β-carboline-3-carboxylic acid.01/2008:0152TUBERCULIN FOR HUMAN USE,OLD Tuberculinum pristinum ad usum humanum DEFINITIONOld tuberculin for human use consists of a?ltrate,concentrated by heating,containing the soluble products of the culture and lysis of one or more strains of Mycobacterium bovis and/or Mycobacterium tuberculosis that is capableof demonstrating a delayed hypersensitivity in an animal sensitised to micro-organisms of the same species.Old tuberculin for human use in concentrated form is a transparent,viscous,yellow or brown liquid. PRODUCTIONGENERAL PROVISIONSThe production of old tuberculin is based on a seed-lot system. The production method shall have been shown to yield consistently old tuberculin of adequate potency and safety in man.A batch of old tuberculin,calibrated in InternationalUnits by the method described under Assay and for which adequate clinical information is available as to its activity in man,is set aside to serve as a reference preparation.The International Unit is the activity of a stated quantity ofthe International Standard.The equivalence in International Units of the International Standard is stated by the World Health Organization.SEED LOTSThe strains of mycobacteria used shall be identi?ed by historical records that include information on their origin and subsequent manipulation.The working seed lots used to inoculate the media for the production of a concentrated harvest shall not have undergone more than4subcultures from the master seed lot.Only seed lots that comply with the following requirements may be used for propagation.Identi?cation.The species of mycobacterium of the master and working seed lots is identi?ed.Bacterial and fungal contamination.Carry out the test for sterility(2.6.1),using10mL for each medium.The workingseed lot complies with the test for sterility except for the presence of mycobacteria.PROPAGATION AND HARVESTThe bacteria are grown in a liquid medium which may be a glycerolated broth or a synthetic medium.Growth must betypical for the strain.The culture is inactivated by a suitable method,such as treatment in an autoclave(121°C for not lessthan30min)or in?owing steam at a temperature not lessthan100°C for at least1h.The culture liquid,from whichthe micro-organisms may or may not have been separatedby?ltration,is concentrated by evaporation,usually toone-tenth of its initial volume.The preparation is free fromlive mycobacteria.The concentrated harvest is shown tocomply with the test for mycobacteria(2.6.2)before additionof any antimicrobial preservative or other substance thatmight interfere with the test.Phenol(5g/L)or anothersuitable antimicrobial preservative that does not give rise tofalse positive reactions may be added.Only a concentrated harvest that complies with the following requirements may be used in the preparation of the?nal bulk tuberculin.pH(2.2.3).The pH of the concentrated harvest is6.5to8.Glycerol.Where applicable,determine the glycerol contentof the concentrated harvest.The amount is within the limits approved for the particular product.3492See the information section on general monographs(cover pages)。
欧洲药典8。0翻译
欧洲药典8.0版3.1 用于包装容器生产的材料这一章描述的是用于药物包装容器生产的材料。
可能还用于部分或全部医疗手术器材的生产。
未包含在药典中的材料或聚合物的使用取决于主管当局的审批。
3.1.6聚丙烯用于注射液和眼用药的包装容器和包装塞定义聚丙烯是由丙烯单独聚合、或者由丙烯、乙烯（不超过25%）共同聚合而成，或者为聚丙烯、聚乙烯（不超过25%）的混合物，这些物质包含他们的同类高聚合物（C4-C10）或者羧酸或者酯类并且不超过25%。
可能含有添加剂。
成品聚合物中会添加一些特定的添加剂以使他们的化学、物理和机械性能更优，以适应预期用途。
所有这些添加剂均选自附件列表，并给出了每个产品中的最大允许含量。
产品中最多只能含有3种抗氧化剂，一种或更多润滑剂或者抗粘连剂，当材料必须提供遮光功能时，还要添加二氧化钛作为遮光剂。
—塑料添加剂07[128-37-0] 丁基羟基甲苯butylhydroxytoluene 抗氧剂BHT 限量：0.125%；—塑料添加剂09[6683-19-8] 四[β-（3，5-二叔丁基-4-羟基苯基）丙酸]季戊四醇酯[pentaerythritol tetrakys 3-(3,5-ditert-butyl-4-hydroxyphenyl )propionate] 抗氧剂1010限量：0.3%；—塑料添加剂13[27676-62-6] 1,3,5-三(3,5-二叔丁基-4-羟基苄基)-顺式-三嗪-2,4,6(1H,3H,5H)-三酮限量：0.3%；—塑料添加剂11[2082-79-3] 3-(3,5-二叔丁基-4-羟基苯基)丙酸正十八碳醇酯octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate 抗氧剂1076 限量：0.3%；—塑料添加剂08[32509-66-3] 3-(1,1-二甲基乙基)-β-[3-(1,1-二甲基乙基)-4-羟苯基]-4-羟基-β-甲基苯甲酸-1,2-亚乙基酯Ethylene bis[3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate] 限量：0.3%；—塑料添加剂15[2500-88-1] 二(十八烷基)二硫化物dioctadecyl disulfide限量：0.3%；—塑料添加剂10[1709-70-2] 2,2′,2″,6,6′,6″-己烷-叔丁基-4,4′,4″-[(2,4,6-三甲基-1,3,5-苯基)三亚甲基]三苯酚2,2′,2″,6,6′,6″-hexa-tert-butyl-4,4′,4″-[(2,4,6-trimethyl-1,3,5-benzenetriyl)trismet hylene] triphenol 抗氧剂330 限量：0.3%；—塑料添加剂14[3806-34-6] 2，2′-二（十八烷基氧）-5，5′-螺[1，3，2-二氧亚磷酸酯]2,2′-bis(octadecyloxy)-5,5′-spirobi[1,3,2-dioxaphosphinane] 限量：0.3%；—塑料添加剂16[123-28-4] 二（十二烷基）3，3′-硫代二丙酸盐didodecyl 3,3′-sulphanediyldipropanoate限量：0.3%；—塑料添加剂17[693-36-7] 硫代二丙酸双十八酯dioctadecyl3,3′-thiodipropionate抗氧剂DSTOP 限量：0.3%；—塑料添加剂12[31570-04-4] 三(2,4-二叔丁基苯基) 亚磷酸酯tris(2,4-di-tert-butylphenyl) phosphate 抗氧剂168 限量：0.3%；以上抗氧化剂总含量不得超过0.3%。
欧洲药典附录中文翻译
附录1溶液的澄清度在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。
浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。
色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。
如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。
试剂：硫酸肼溶液：取1.0g硫酸肼溶于水，加水稀释至100.0ml，静臵4～6小时。
乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以25.0ml水溶解2.5g 乌洛托品。
浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加25.0ml的硫酸肼溶液。
混合，静臵24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。
该浊度液不得黏附玻璃，用前必须充分摇匀。
浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。
该液临用前制备，至多保存24小时。
浊度标准液：由浊度标准原液与水按表1-1配制,即得。
本液应临用前配制。
表1-1附录2溶液颜色检查按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。
如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B9，则可判定溶液A为无色。
方法I用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。
在散射自然光，白色的背景下，水平观察比较颜色。
方法Ⅱ用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。
在散射自然光，白色的背景下，垂直地观察比较颜色。
贮备液黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容1000.0ml。
欧洲药典EP8.0 滴位测定 中文翻译
2.2.20. POTENTIOMETRIC TITRATION 电位滴定In a potentiometric titration the end-point of the titration isdetermined by following the variation of the potential difference between 2electrodes (either one indicator electrode and one reference electrode or 2indicator electrodes) immersed in the solution to be examined as a function ofthe quantity of titrant added.在一个电位滴定中，滴定终点判定是依据浸入被测液中两支电极（或者是一支指示电极一支参比电极，或者是两支指示电极）之间的电位差，对应加入滴定液的数量。
The potential is usually measured at zero or practically zerocurrent.电位一般在零点测量，或在零点电流。
Apparatus. The apparatus used (a simple potentiometer or electronicdevice) comprises a voltmeter allowing reading to the nearest millivolt.仪器：所用仪器（一个简单的电位计或电极装置）包括一个可以准确读至毫伏的电位计。
The indicator electrode to be used depends on the substance to bedetermined and may be a glass or metal electrode (for example, platinum, gold,silver or mercury). The reference electrod is generally a calomel or asilver-silver chloride electrode.所用的指示电极依赖于所检测的物质，可以是玻璃电极或金属电极（例如，铂电极、金电极、银或水银电极）。
纯化水英汉对照-欧洲药典8.0
ATCC 9027/大豆酪蛋白消化物琼脂培养基或液体培
NCIMB 8626
CIP
82.118
NBRC 13275xx
30-35 °C
18-24 h≤ 100 CFU30-35 °C≤ 3 daysBacillus subtilis
Casein soyabean digest agar or casein
0008.-
促生长试验：
测试每批已制备好的培养基,以及使用脱水培养基制备或按指定成分制备的培养基。分别将表
0008.-1中指定的少量菌悬液（不超过100CFU）接种在R2A琼脂上。按表中指定条件进行培养。
所得的培养结果，不可超过已标定培养液的培养结果加上2的因子。
对于新鲜制备的培养液，微生物的生长必须与先前测试并且已认可的批次的培养基的培养结果有可比性。
-accuracy :
within 3per cent of the measured conductivity plus
0.1μS?cm?
1.
电导率仪：
准确度应为
0.1μS²cm-1
或在最低范围更佳
系统校正（电导池和电导率仪）：
-使用一个或多个已经鉴定的参照溶液；
-准确度：
在被测电导率加
0.1μS²cm-1
WATER, PURIFIED
纯化水H2O Mr18.12DEFINITION
Water for the preparation of medicines other than those that are required to be both sterile and apyrogenic,unless otherwise justified and authorized.
欧洲药典-凡例(中英文对照)
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。
欧洲药典EP8.0硫酸灰
欧洲药典EP8.0硫酸灰2.4.14. SULFATED ASH 硫酸灰分Ignite a suitable crucible (for example, silica, platinum, porcelain or quartz) at 600+/-50℃ for 30 min, allow to cool in a desiccator over silica gel or other suitable desiccant and weigh. Place the prescribed amount of the substance to be examined in the crucible and weigh. Moisten the substance to be examined with a small amount of sulfuric acid R (usually 1 mL) and heat gently at as low a temperature as practicable until the sample is thoroughly charred. After cooling, moisten the residue with a small amount of sulfuric acid R (usually 1 mL), heat gently until white fumes are no longer evolved and ignite at 600+/-50℃ until the residue is completely incinerated. Ensure that flames are not produced at any time during the procedure. Allow the crucible to cool in a desiccator over silica gel or other suitable desiccant, weigh it again and calculate the percentage of residue.将合适的坩埚（例如硅、铂、瓷或石英）在600+/-50℃灼烧30分钟，在有硅胶或其它合适的干燥剂的干燥器内冷却，称重。
EP8.0干燥失重2.2.32
2.2.32 Loss on dryingLoss on drying is the loss of mass expressed as per cent m/m.Method. Place the prescribed quantity of the substance tobe examined in a weighing bottle previously dried underthe conditions prescribed for the substance to be examined.Dry the substance to constant mass or for the prescribedtime by one of the following procedures. Where the dryingtemperature is indicated by a single value rather than a range,drying is carried out at the prescribed temperature ± 2 °Ca) “in a desiccator” : the drying is carried out overdiphosphorus pentoxide R at atmospheric pressure and atroom temperature;b) “in vacuo”: the drying is carried out over diphosphoruspentoxide R, at a pressure of 1.5 kPa to 2.5 kPa at roomtemperature;c) “in vacuo within a specified temperature range”: thedrying is carried out over diphosphorus pentoxide R, at apressure of 1.5 kPa to 2.5 kPa within the temperature rangeprescribed in the monograph;d) “in an oven within a specified temperature range”: thedrying is carried out in an oven within the temperaturerange prescribed in the monograph;e) “under high vacuum”: the drying is carried out overdiphosphorus pentoxide R at a pressure not exceeding0.1 kPa, at the temperature prescribed in the monograph.If other conditions are prescribed, the procedure to be used isdescribed in full in the monograph2.2.32 干燥失重干燥损失是质量损失的百分比m/m。
Alfacalcidol-欧洲药典EP8.0
Alfacalcidol EUROPEAN PHARMACOPOEIA8.0Limits :–impurities A,B :for each impurity,not more than the area of the principal peak in the chromatogram obtained with reference solution (a)(0.5per cent)and not more than one of the peaks has an area greater than the area of the principal peak in the chromatogram obtained with reference solution (b)(0.2per cent);–total :not more than twice the area of the principal peak in the chromatogram obtained with reference solution (a)(1per cent);–disregard limit :the area of the principal peak in the chromatogram obtained with reference solution (c)(0.05per cent).Water (2.5.12):maximum 5.0per cent,determined on 0.500g.Sulfated ash (2.4.14):maximum 0.1per cent,determined on 1.0g.ASSAYDissolve 0.300g by stirring in 70mL of acetic anhydride R for 1min.Titrate with 0.1M perchloric acid until the colour changes from violet-blue to greenish-blue,using 0.1mL of crystal violet solution R as indicator.1mL of 0.1M perchloric acid is equivalent to 36.9mg of C 44H 50Cl 2N 4O 2.STORAGEIn an airtight container under nitrogen,protected from light,at a temperature of 2°C to 8°C.IMPURITIESSpecified impurities:A,B.A.(1R ,3a S ,9R ,9a R ,10R ,11a S ,12R ,14a S ,19a S ,20R ,-20a R ,20b S ,21R ,22a S )-1,12-bis(prop-2-enyl)-2,3,9a,11,11a,13,14,19a,20a,21,22,22a-dodecahydro-10H ,20b H -1,23:12,27-dimethano-9,10:20,21-bis(epoxyprop[2]eno)-9H ,20H -[1,5]diazocino[1,2,3-lm :5,6,7-l ′m ′]dipyrrolo[2′,3′-d :2′′,3′′:d ′]dicarbazolediium dichloride (4,4′-diallylcaracurin Vdichloride),B.(4b S ,7R ,7a S ,8a R ,13R ,13a R ,13b S )-13-hydroxy-7-(prop-2-enyl)-5,6,7a,8,8a,11,13,13a,13b,14-decahydro-7,9-methano-7H -oxepino[3,4-a ]pyrrolo[2,3-d ]carbazolium chloride ((4R ,17R )-4-allyl-17,18-epoxy-17-hydroxy-19,20-didehydrocuranium chloride).01/2014:1286ALFACALCIDOLAlfacalcidolumC 27H 44O 2M r 400.6[41294-56-8]DEFINITION(5Z ,7E )-9,10-Secocholesta-5,7,10(19)-triene-1α,3β-diol.Content :97.0per cent to 102.0per cent.A reversible isomerisation to pre-alfacalcidol takes place in solution,depending on temperature and time.The activity is due to both compounds (see Assay).CHARACTERSAppearance :white or almost white crystals.Solubility :practically insoluble in water,freely soluble in ethanol (96per cent),soluble in fatty oils.It is sensitive to air,heat and light.IDENTIFICATIONA.Infrared absorption spectrophotometry (2.2.24).Comparison :Ph.Eur.reference spectrum of alfacalcidol .B.Examine the chromatograms obtained in the test for related substances.Results :the principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).TESTSRelated substances .Liquid chromatography (2.2.29):use the normalisation procedure.Carry out the test as rapidly as possible,avoiding exposure to light and air.Test solution.Dissolve 1.0mg of the substance to be examined without heating in 10.0mL of the mobile phase.Reference solution (a).Dissolve 1.0mg of alfacalcidol CRS without heating in 10.0mL of the mobile phase.Reference solution (b).Dilute 1.0mL of reference solution (a)to 100.0mL with the mobile phase.Dilute 1.0mL of this solution to 20.0mL with the mobile phase.Reference solution (c).In order to prepare pre-alfacalcidol in situ ,dissolve the contents of a vial of alfacalcidol for system suitability CRS (containing impurities A and B)in 25mL of the mobile phase,heat in a water-bath at 80°C under a reflux condenser for 2h and cool.Column :–size :l =0.25m,Ø=4.6mm;–stationary phase :end-capped octadecylsilyl silica gel for chromatography R (5μm).Mobile phase :ammonia R ,water R ,acetonitrile R (1:200:800V/V/V ).Flow rate :2.6mL/min.Detection :spectrophotometer at 265nm.Injection :100μL of the test solution and reference solutions (b)and (c).1498See the information section on general monographs (cover pages)EUROPEAN PHARMACOPOEIA 8.0AlfadexRun time :twice the retention time of alfacalcidol.Identification of impurities :use the chromatogramsupplied with alfacalcidol for system suitability CRS and the chromatogram obtained with reference solution (c)to identify the peaks due to impurities A and B.Relative retention with reference to alfacalcidol (retention time =about 21min):pre-alfacalcidol =about 0.88;impurity A =about 0.93;impurity B =about 1.1.System suitability :reference solution (c):–resolution :minimum 1.5between the peaks due to pre-alfacalcidol and impurity A and minimum 1.5between the peaks due to impurity A and alfacalcidol.Limits :–impurities A,B :for each impurity,maximum 0.5per cent;–unspecified impurities :for each impurity,maximum 0.10per cent;–total :maximum 1.0per cent;–disregard limit :the area of the principal peak in the chromatogram obtained with reference solution (b)(0.05per cent);disregard the peak due to pre-alfacalcidol.ASSAYLiquid chromatography (2.2.29)as described in the test for related substances with the following modifications.Injection :test solution and reference solutions (a)and (c).System suitability :reference solution (c):–repeatability :maximum relative standard deviation of 1per cent for the peak due to alfacalcidol after 6injections.Calculate the percentage content of C 27H 44O 2taking into account the assigned content of alfacalcidol CRS and,if necessary,the peak due to pre-alfacalcidol.STORAGEUnder nitrogen,in an airtight container,protected from light,at a temperature of 2°C to 8°C.The contents of an opened container are to be used immediately.IMPURITIESSpecified impurities:A,B .Other detectable impurities (the following substances would,if present at a sufficient level,be detected by one or other of the tests in the monograph.They are limited by the general acceptance criterion for other/unspecified impurities and/or by the general monograph Substances for pharmaceutical use (2034).It is therefore not necessary to identify these impurities for demonstration of compliance.See also 5.10.Control of impurities in substances for pharmaceutical use ):C.A.(5E ,7E )-9,10-secocholesta-5,7,10(19)-triene-1α,3β-diol (trans-alfacalcidol), B.(5Z ,7E )-9,10-secocholesta-5,7,10(19)-triene-1β,3β-diol(1β-calcidol),C.6ξ-[(3S ,5R )-3,5-dihydroxy-2-methylcyclohex-1-en-1-yl]-2-phenyl-2,5,10-triaza-4,19-dinor-9ξ-cholest-7-ene-1,3-dione.01/2012:1487ALFADEXAlfadexum[C 6H 10O 5]6M r 973[10016-20-3]DEFINITIONCyclohexakis-(1→4)-(α-D -glucopyranosyl)(cyclomaltohexaose or α-cyclodextrin).Content :97.0per cent to 102.0per cent (dried substance).CHARACTERSAppearance :white or almost white,amorphous or crystalline powder.Solubility :freely soluble in water and in propylene glycol,practically insoluble in anhydrous ethanol and in methylene chloride.IDENTIFICATIONA.Specific optical rotation (see Tests).B.Examine the chromatograms obtained in the assay.Results :the principal peak in the chromatogram obtained with test solution (b)is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (c).C.Dissolve 0.2g in 2mL of iodine solution R4by warming on a water-bath,and allow to stand at room temperature;a yellowish-brown precipitate is formed.General Notices (1)apply to all monographs and other texts1499。
EP_8.0-2.6.13_非无菌药品的微生物限度检查：特殊微生物的检查(中英对照)
04/2010:20613 2.6.13. MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3)非无菌药品的微生物限度检查：特殊微生物的检查1. INTRODUCTION 导言The tests described hereafter will allow determination of the absence or limited occurrence of specified micro-organisms that may be detected under the conditions described.下述检验方法用于检查在描述的试验条件下特定微生物的定性及限度。
The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below.检验的主要目的是为了确定是否原料药或制剂符合已建立的微生物限度标准，当用于这一目的时，应按照以下方式（包括取样量），进行并按照下述描述对结果进行分析。
Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopoeia method has been demonstrated.如果可证明某种试验方法（包括自动化分析法）的效果与药典中的方法等同，该方法可作为另一种供选择的试验方法。
药品检验报告英语001
【分享】药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。
EP8.0细菌内毒素检查法中英文对照
EP8.0 2.6.14 细菌内毒素（中英文）2.6.14. BACTERIAL ENDOTOXINS 细菌内毒素The test for bacterial endotoxins (BET) is used to detect or quantify endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphenmus or Tachypleus tridentatus). There are 3 techniques for this test: the gel-clot techniques, which is based on gel formation; the turbidimetric technique, based on the development of turbidity after cleavage of an endogenouse substrate; and the chromogenic technique, based on the development of colour after cleavage of a synthetic peptide-chromogen complex.本法利用鲎试剂（从鲎——美洲鲎或中国鲎——变形细胞溶解物制备而来）检测由革兰氏阴性菌产生的细菌内毒素或对内毒素进行定量。
该检查包括三种方法：一为凝胶法，系利用鲎试剂与内毒素产生凝集反应的原理；第二种为浊度法（基于内源性底物断裂后，产生的浊度变化）；最后一种为显色法（得到的肽－呈色基团复合物断裂后，检测反应混合物的色度）。
The following 6 methods are described in the present chapter:这一章阐述了下面6种方法：Method A. Gel-clot method: limit testMethod B. Gel-clot method: quantitative testMethod C. Turbidimetric kinetic methodMethod D. Chromogenic kinetic methodMethod E. Chromogenic end-point methodMethod F. Turbidimetric end-point method方法A：凝胶法：限度试验方法B：凝胶法：定量试验方法C：动态浊度法方法D：动态显色法方法E：终点显色法方法F：终点浊度法Proceed by any of the 6 methods for the test. In the event of doubt or dispute, the final decision is made based upon method A unless otherwise indicated in the monograph.检测时，可用6种方法的任一种进行试验。
欧洲药典8.0-凡例双语版
1 GENERAL NOTICES凡例1.1 GENERAL STATEMENTS概述The General Notices apply to all monographs and other texts of the EuropeanPharmacopoeia.凡例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 andFrench. Translations in other languages may be prepared by the signatoryStates 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，官方缩写 Ph. Eur.也指欧洲药典。
The use of the title or the subtitle of a monograph implies that the articlecomplies with the requirements of the relevant monograph. Such references tomonographs in the texts of the Pharmacopoeia are shown using themonograph 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。
欧洲药典-凡例(中英文对照)
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。
欧洲药典中文翻译
附录1溶液的澄清度在内径15～25mm，平底，无色、透明、中性玻璃管中，加入等量的供试溶液与浊度标准液，使液位的深度都为40mm，按如下所述方法进行比较。
浊度标准液制备5分钟后，以色散自然光照射浊度标准溶液和供试溶液，在黑色背景下从垂直方向观察、比较澄清度或浑浊程度。
色散自然光必须较容易区分浊度标准溶液Ⅰ与水，浊度标准溶液Ⅱ与浊度标准溶液Ⅰ。
如果供试溶液的澄清、透明程度与水相同，或者与所用溶剂相同，或者其澄清度不超过Ⅰ号浊度标准溶液，那么可判定该溶液为澄清。
试剂：硫酸肼溶液：取硫酸肼溶于水，加水稀释至，静置4～6小时。
乌洛托品（六亚甲基四胺）溶液：在100ml容量平中，以水溶解乌洛托品。
浊度标准贮备液：在存放乌洛托品溶液的100ml容量瓶中，加的硫酸肼溶液。
混合，静置24小时，贮存在无表面要求的玻璃容器中，可在2个月内使用。
该浊度液不得黏附玻璃，用前必须充分摇匀。
浊度标准原液：取浊度标准贮备液15ml，加水稀释、定容至1000ml。
该液临用前制备，至多保存24小时。
浊度标准液：由浊度标准原液与水按表1-1配制,即得。
本液应临用前配制。
表1-1附录2 溶液颜色检查按本药典规定，用下面两种方法之一可以检出溶液在棕色-黄色-红色范围内的颜色。
如果溶液A的外观与水或所用溶剂相同，或者颜色浅于标准比色液B9，则可判定溶液A为无色。
方法I用外径为12mm的无色、透明中性玻璃管取2ml的供试溶液，与相同玻璃管中的2ml的水，或2ml本文所规定的标准比色液（见标准比色液表）进行比较。
在散射自然光，白色的背景下，水平观察比较颜色。
方法Ⅱ用同样平底、内径为15～25mm的无色透明中性玻璃管，液位的深度为40mm，将供试溶液与水或溶剂或本文中规定的标准比色液（见标准比色液表）对比。
在散射自然光，白色的背景下，垂直地观察比较颜色。
贮备液黄色液称取46克氯化铁，加大约900ml盐酸溶液（25ml浓盐酸和975ml水混和）溶解，继续添加，并定容。
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2.2.32. LOSS ON DRYING 干燥失重
Loss on drying is the loss of mass expressed as per cent m/m.
干燥失重指重量损失，表述为% 重量/重量
Method. Place the prescribed quantity of the substance to be examined in a weighing bottle previously dried under the conditions prescribed for the substance to be examined. Dry the substance to constant mass or for the prescribed time by one of the following procedures. Where the drying temperature is indicated by a single value rather than a range, drying is carried out at the prescribed temperature +/- 2?C.
方法：将要求数量的待检样品放置于预先干燥的称量瓶中，按要求条件进行干燥，直至样品干至恒重或下述程序指定的时长。
如果干燥温度给定的是一个值而不是一个范围，则在指定温度+/- 2?C进行干燥。
a) “in a desiccator”: the drying is carried out over diphosphorus pentoxide R at atmospheric atmostpheric pressure and at room temperature;
“在干燥器中”：指在室温常压下，用五氧化二磷试剂，进行干燥
b) “in vacuo”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5 kPa at room temperature;
“真空”：在室温下，真空1.5kPa下，用五氧化二磷试剂进行干燥
c) “in vacuo within a specified temperature range”: the drying is carried out over diphosphorus pentoxide R, at a pressure of 1.5kPa to 2.5kPa within the temperature range prescribed in the monograph;
“在指定温度范围内真空下”：真空1.5kPa至2.5kPa下，各论要求的温度范围内，用五氧化二磷进行干燥
d) “in an oven within a specified temperature range”: the drying is carrie d out in an oven within the temperature range prescribed in the monograph;
“在烘箱里指定温度下”：在各论要求的温度范围内，用烘箱进行干燥
e) “under high vacuum”: the drying is carried out over diphosphorus pentoxide R at a pressure not exceeding 0.1kPa, at the temperature prescribed in the monograph.
“在高真空下”：在各论要求的温度下，不超过0.1kPa的真空下用五氧化二磷进行干燥
If other conditions are prescribed, the procedure to be used is described in full in the monograph.
如果需要采用其它条件，则在各论中应进行详细描述。