纯化水英汉对照

1、WATER, PURIFIED纯化水H2OMr 18.12DEFINITIONWater 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

2、 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

3、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 subsequentstorage, appropriate measures are taken to ensure that the microbial count is adequately contr

4、olled 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 of 100 CFU/mL, determined by filtration through a membrane with a nominal pore size not greater than 0.45 卩 musing R2A agar and i

5、ncubating at 30-35 C for not less than 5 days. 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。设置适当的警戒限和行动限以检测不利趋势。 在正常条件下，用公称孔径不大于0.45卩m微孔滤膜过滤后，采用R2A 琼脂于 30-35C 下培养至少 5 天，微生物限度的行动限是 100CFU/mL。检测所用的样品量根据期望的结果进行选择。Yeast extract

6、 酵/ 母膏 0.5gProteose peptone蛋白胨 0.5gCasein hydrolysate水解酪蛋白 0.5gGlucose/葡萄糖 0.5gStarch淀粉 0.5 gDipotassium hydrogen phosphate磷酸氢二钾 0.3 gMagn esium sulfate, an hydrous无 水硫酸镁 0.024 gSodium pyruvate丙酮酸钠 0.3 gAgar/ 琼脂 15.0 gPurified water/纯化水 可达 1000 mLAdjust the pH so that after sterilisation it is 7.20.

7、2. Sterilise by heatingin an autoclave at 121 C for 15min.适当调整pH，使灭菌后的pH为7.2 士 0.2。通过121 C高压灭菌 锅中加热 15 分钟进行灭菌。Growth promotion of R2A agar Preparation of test strains. Use standardised stable suspensions of test strains or prepare them as stated in Table 0008.-1. Seed lot culture maintenance techniq

8、ues (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot. Grow each of the bacterial strains separately as described in Table 0008.-1. Use buffered sodium chloride-peptone solution pH 7.0 or phospha

9、te buffer solution pH 7.2 to make test suspensions. Use the suspensions within 2 h, or within 24 h if stored at 2-8 C. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis, a stable spore suspension is prepared and then an appropriate volume of

10、 the spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 C for a validated period of time.R2A 琼脂促生长试验： 测试菌株的制备：使用标定过的稳定的测试菌悬浮液或按表 0008.-1 中所述的方法制备。 采用适当的菌株批保藏技术以保证菌株从原始菌 株中传代次数不超过 5 代。根据表 0008.-1 描述，每次菌株分开培养。 使用 pH 为 7.0 的氯化钠 -蛋白胨缓冲溶液或 pH 为 7.2 的磷酸盐缓冲

11、液制备测试悬浮液。悬浮液应在 2小时内使用，如保存在 2-8C 则 可在 24 小时内使用。作为制备并稀释枯草芽孢杆菌营养细胞新鲜悬 浮液的替代方法， 也可以制备稳定的孢子悬浮液， 然后使用体积适合 的 孢子悬浮液进行接种测试。孢子悬浮液需在2-8 C、且已验证的期限内保存。 Growth promotion. Test each batch ofready-prepared medium and each batch of medium, prepared either from dehydrated medium or from theingredients described. Inoc

12、ulate plates of R2A agar separately with a small number(not more than 100 CFU)of the micro-organisms indicatedin Table 0008.-1. Incubate under the conditions described in the table. Growthobtained must not differ by a factorgreater than 2 from the calculated value for a standardizedinoculum. For a f

13、reshly prepared inoculum, growth ofthe micro-organisms must be comparable to that obtained with a previouslytested and approved batch of medium.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

14、已认可的 批次的培养基的培养结果有可比性。Table0008.-1. -Growth promotion of R2A agar表0008.-1. R2A琼脂培养基Micro-orga nism微生物Preparati on of the test stra in测试菌株的制备Growthpromotio n促生长试验Pseudo monas aerugi nosasuch as/铜绿假单孢菌，例如 ：ATCC 9027Case in soyabea n digest agar or case in soyabea n digest broth/大豆酪蛋白消化物琼脂培养基或液体培R2A aga

15、r/R2A琼脂NCIMB 8626CIP 82.118NBRC 13275养基30-35 C18-24 h 100 CFU30-35 C 3 daysBacillus subtilissuch as/枯草芽孢杆菌，例如：ATCC 6633NCIMB 8054CIP 52.62NBRC 3134Case in soyabea n digest agar or case in soyabea n digest broth/大豆酪蛋白消化物琼脂培养基或液体培养基30-35 C18-24 hR2A agar/R2A琼脂w 100 CFU30-35 Cw 3 daysTotal orga nic car

16、b on or oxidisable substa nces. Carry out the test for total orga nic carb on (2244) with a limit of 0.5 mg/L or alter natively the following test for oxidisable substances: to 100 mL add 10 mL of dilute sulfuric acid R and 0.1 mL of 0.02 M potassium perma ngan ate and boil for 5 min ; the solution

17、remains faintly pink.总有机碳或易氧化物：按（ 2.2.44）所描述的方法测试总有机碳，应不超过0.50mg/L;或按下述方法测试易氧化物：取本品 100mL，加 稀硫酸R 10mL和0.02M高锰酸钾溶液0.1mL，煮沸5min，溶液仍 然略显粉红色。Conductivity. Determine the conductivity off-line or in-line under the following conditions.电导率：按下列条件进行离线或在线电导率测试。EQUIPMENTConductivity cell:- electrodes of a suit

18、able material such as stainless steel ;- cell constant : the cell constant is generally certified by the supplier and is subsequently verified at suitable intervals using a certified reference-1solution with a conductivity less than 1500 cm or bygomparisonwith a cell having a certified cell constant

19、 ; the cell constant is confirmed if the value found is within 2 per cent of the certified value, otherwise re-calibration must be performed.设备电导池：适合的材料的电极，如不锈钢; 电导池常数：电导池常数通常由供应商鉴定，且应以适当的周期、用电导率已鉴定低于1500小cm-1的参照溶液或者用一个导电池常数已鉴定的电导池进行确认；如果测得值在鉴定值的 2%以内，则符合 规定，否则必须重新校准。-1Conductometer : accuracy of 0.

20、1 卩 S cm 1 or better at the lowest range.System calibration (conductivity cell and conductometer) :- against one or more suitable certified reference solutions ;- accuracy : within 3 per cent of the measured conductivity plus 0.1 a S?cm? 1.电导率仪：准确度应为0.1 a S - cm-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

21、鉴定的参照溶液；-准确度：在被测电导率加0.1 aS- cm-1的3%以内。Conductometer calibration : calibration is carried out for each range of measurement to be used, after disconnection of the conductivity cell, using certified precision resistors or equivalent devices with an uncertainty not greater than 0.1 per cent of the cert

22、ified value. If in-line conductivity cells cannot be dismantled, system calibration may be performed against a calibrated conductivity-measuring instrument with a conductivity cell placed close to the cell to be calibrated in the water flow. 电导率仪的校准：每个量程都应被校准。断开电导池后，使用已鉴定 的精密电阻器或不确定度不超过鉴定值 0.1%的等同设备

23、进行校准。 如果在线电导池不能被断开， 可使用已校准的电导率测量仪器、 将其 电导池放置在水流中的目标电导池附近进行校准。Temperature measurement : tolerance2 C. 测量温度：误差 2 C.PROCEDURE / 操作程序Measure the conductivity without temperature compensation, recording simultaneously the temperature. Temperature-compensated measurement may be performed after suitable va

24、lidation.测量未经温度补偿的电导率，同时记录温度。经适当的验证后，可以 进行温度补偿测量。The water to be examined meets the requirements if the measured conductivity at the recorded temperature is not greater than the value in Table 0008.-2.如在记录的温度下测得的电导率不超过表 0008.-2 中的值，则被检测 水符合要求Table 0008.-2. Temperature and conductivity requirements 温

25、度禾口电导率要求Temperature /温度 (C)Conductivity/ 电导率(卩 S - cm- 1)02.4103.6204.3255.1305.4406.5507.1608.1709.1759.7809.7909.710010.2For temperatures not listed in Table 0008.-2, calculate the maximal permitted conductivity by interpolation between the next lower and next higher data points in the table.如温度未在

26、表 0008.-2 列出，则使用内插法、根据(该温度)相邻两 高低数据点计算最大电导率限度值。Heavy metals. If purified water in bulk complies with the requirement for conductivity prescribed for Water for injections (0169) in bulk, it is not necessary to carry out the test for heavy metals prescribed below. 重金属：如果散装纯化水符合散装注射用水 （0169）的电导率的规定， 则不

27、需要进行下述规定的重金属检测。CHARACTERS / 性状Appearance : clear and colourless liquid. 外观：无色透明液体。TESTS/测试Nitrates : maximum 0.2 ppm.Place 5 mL in a test-tube immersed in iced water, add 0.4 mL of a 100 g/L solution of potassium chloride R, 0.1 mL of diphenylamine solution R and, dropwise with shaking, 5 mL of nitr

28、ogen-free sulfuric acid R. Transfer the tube to a water-bath at 50 C. After 15 min, any blue colour in the solution is not more intense than that in a reference solution prepared at the same time in the same manner using a mixture of 4.5 mL of nitrate-free water R and 0.5 mL of nitrate standard solu

29、tion (2 ppm NO3) R.硝酸盐： 应不超过 0.2ppm。取本品 5mL 置于试管中， 于冰水中冷却， 加 0.4mL 浓度 100g/L 的氯 化钾溶液R、0.1mL二苯胺溶液R,边震荡边逐滴加入无氮硫酸 R 5m L 。将试管置于 50C 水浴。15 分钟后，溶液所显蓝色与相同时 间相同方式制备的 0.5mL 硝酸盐标准溶液( 2ppm NO3)R 与 4.5mL 硝酸盐的水 R 混合而成的对照溶液比较，不得更深。Aluminium (2.4.17) : maximum 10 ppb, if intended for use in the manufacture of dia

30、lysis solutions.Prescribed solution. To 400 mL of the water to be examined add 10 mL of acetate buffer solution pH 6.0 R and 100 mL of distilled water R. Reference solution. Mix 2 mL of aluminium standard solution (2 ppm Al) R, 10 mL of acetate buffer solution pH 6.0 R and 98 mL of distilled water R

31、.Blank solution. Mix 10 mL of acetate buffer solution pH 6.0 R and 100 mL of distilled water R.铝( 2.4.17)：如果用于透析溶液，含量应不超过 10ppb。指定溶液：取本品400mL，力口 10mL pH6.0的醋酸盐缓冲溶液 R和 100mL 蒸馏水 R 。对照溶液：将 2mL 铝标准溶液( 2ppm Al)R 与 10mL pH 6.0的醋酸 盐溶液 R 和 98mL 蒸馏水 R 混合。空白溶液：取10mL pH 6.0的醋酸缓冲溶液和100mL蒸馏水R,混合。Heavy metals (2

32、.4.8) : maximum 0.1 ppm.To 200 mL add 0.15 mL of 0.1 M nitric acid and heat in a glass evaporating dish on a water-bath until the volume is reduced to 20 mL. 12 mL of the concentrated solution complies with test A. Prepare the reference solution using 10 mL of lead standard solution （1 ppm Pb） R and

33、 adding 0.075 mL of 0.1 M nitric acid. Prepare the blank solution adding 0.075 mL of 0.1 M nitric acid.重金属（ 2.4.8）：应不超过 0.1ppm。取本品200mL，加0.1M硝酸0.15mL,置一玻璃蒸发皿中水浴加热 直至溶液体积减少至20mL。取此浓缩溶液12mL按方法A进行测试。取10mL铅标准溶液（1ppm Pb） R,加0.075mL 0.1M硝酸溶液制备 参照溶液。加入0.1M硝酸溶液0.075mL制备空白溶液。Bacterial endotoxins （2.6.14） : l

34、ess than 0.25 IU/mL, if intended for use in the manufacture of dialysis solutions without a further appropriate procedure for removal of bacterial endotoxins.细菌内毒素（ 2.6.14）：无进一步适当的措施除去细菌内毒素、直接用 于透析溶液，细菌内毒素应小于 0.25 IU/mL。LABELLINGThe label states, where applicable, that the substance is suitable for

35、use in the manufacture of dialysis solutions.标签： 在适用的情况下，标签应标明本品适合用于透析溶液。Purified water in containers桶装纯化水DEFINITIONPurified water in bulk that has been filled and stored in conditions designed to assure the required microbiological quality. It is free from any added substances.定义 散装纯化水被灌装和贮存在经设计可以保

36、证微生物质量要求的条件 下。没有新增物质。CHARACTERSAppearance: clear and colourless liquid.性状外观：无色透明液体。TESTSIt complies with the tests prescribed in the section on Purified water in bulk and with the following additional tests.测试 桶装纯化水应符合散装纯化水以及下面所描述的测试要求。Acidity or alkalinity. To 10mL, freshly boiled and cooled in a b

37、orosilicate glass flask, add 0.05mL of methyl red solution R.The solution is not coloured red.To 10mL add 0.1 mL of bromothymol blue solution R1. The solution is not coloured blue.酸碱度：取本品 10mL 置于一硼硅酸玻璃烧瓶中煮沸并放冷却，添加 0.05mL 甲基红溶液 R, 溶液不得显红色。取本品 10mL 加溴麝香草酚蓝溶液 R1 0.1mL, 溶液不得显蓝色。 Oxidisable substances. T

38、o 100mL add 10mL of dilute sulfuric acid R and 0.1mL of 0.02M potassium permanganate and boil for 5min. The solution remains faintly pink.易氧化物：取本品 100mL 加稀硫酸 R10mL 及 0.02M 高锰酸钾 0.1mL 煮沸 5 分钟，溶液仍微显粉红色。Chlorides. To 10mL add 1 mL of dilute nitric acid R and 0.2 mL of silver nitrate solution R2. The so

39、lution shows no change in appearancefor at least 15min.氯化物：取本品 10mL 加 1mL 稀硝酸 R 和 0.2mL 硝酸银溶液 R2， 至少 15 分钟内溶液外观不应发生变化。Sulfates. To 10mL add 0.1mL of dilute hydrochloric acid R and 0.1mL of barium chloride solution R1. The solution shows no change in appearance for at least 1 h.硝酸盐：取本品 10mL 加 0.1mL 稀盐酸 R 和 0.1mL 氯化钡溶液 R1， 至少在一小时内溶液外观不应发生变化。Ammonium: maximum 0.2ppm.To 20mL add 1mL of alkaline potassium tetr