纯化水英汉对照-欧洲药典8.0

WATER, PURIFIED

纯化水

H 2O M r 18.12 DEFINITION

Water 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

PRODUCTION

Purified 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 of 100 CFU/mL, determined by filtration through a membrane with a nominal pore size not greater than 0.45 μm, using R2A agar and incubating 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0.45μm 微孔滤膜过滤后，采用R2A 琼脂于30-35°C 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 /酵母膏 0.5g

Proteose peptone/蛋白胨 0.5g

Casein hydrolysate/水解酪蛋白 0.5g

Glucose/葡萄糖 0.5g

Starch/淀粉 0.5 g

Dipotassium hydrogen phosphate/磷酸氢二钾 0.3 g

Magnesium sulfate, anhydrous/无水硫酸镁 0.024 g

Sodium pyruvate/丙酮酸钠 0.3 g

Agar/琼脂 15.0 g

Purified water/纯化水 可达1000 mL

Adjust the pH so that after sterilisation it is 7.2 ± 0.2. Sterilise by heating in an autoclave at 121 °C for 15 min.

适当调整pH ，使灭菌后的pH 为7.2 ± 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 techniques (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 phosphate 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 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的磷酸盐缓冲液制备测试悬浮液。悬浮液应在2小时内使用，如保存在2-8°C 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. Inoculate 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 freshly 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

Total organic carbon or oxidisable substances. Carry out the test for total organic carbon (2.2.44) with a limit of 0.5 mg/L or alternatively 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 permanganate and boil

for 5 min ; the solution 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。

EQUIPMENT

Conductivity cell:

- electrodes of a suitable 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 solution with a conductivity less than 1500 μS²cm -1 or by comparison with a cell having a certified cell constant ; 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 μS²cm -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。

Conductometer : accuracy of 0.1 μS²cm -1 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 μS?cm? 1.

电导率仪：准确度应为0.1 μS²cm -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0.1 μS²cm -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 certified 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 : tolerance ±2 °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 validation.

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 温度和电导率要求

Temperature /温度 (°C) Conductivity/电导率 (μS ²cm - 1)

0 2.4

10 3.6

20 4.3

25 5.1

30 5.4

40 6.5

50 7.1

60 8.1

70 9.1

75 9.7

80 9.7

90 9.7

100 10.2

For 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 nitrogen-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 solution (2 ppm NO 3) 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 5mL 。将试管置于50°C 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 dialysis 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.

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 ，加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 (2.4.8) : 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 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) : less 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。

LABELLING

The label states, where applicable, that the substance is suitable for 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

DEFINITION

Purified 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证微生物质量要求的条件下。没有新增物质。

CHARACTERS

Appearance: clear and colourless liquid.

性状

外观：无色透明液体。

TESTS

It 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 borosilicate 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. To 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 solution shows no change in appearance for 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 tetraiodomercurate solution R. After 5 min, examine the solution down the vertical axis of the tube. The

solution is not more intensely coloured than a standard prepared at the same time by adding 1mL of alkaline potassium tetraiodomercurate solution R to a mixture of 4mL of ammonium standard solution(1ppm NH 4) R and 16mL of ammonium-free water R.

铵盐：不应超过0.2ppm

取本品20mL 加1mL 碱性碘化汞钾溶液R 与4mL 铵标准溶液(1ppm NH 4) R 加无铵水R16mL 和碱性碘化汞钾溶液1mL 制成的对照液比较，样品溶液与对照溶液同时制备并放置5分钟后沿试管垂直方向进行观察样品溶液的颜色不得比对照溶液更深。

Calcium and magnesium. To 100mL add 2mL of ammonium chloride buffer solution pH 10.0R, 50 mg of mordant black 11 triturate R and 0.5mL of 0.01 M sodium edetate. A pure blue colour is produced.

钙盐和镁盐：取本品100mL 加2mL pH10.0的氯化铵缓冲溶液，50mg 铬黑11粉末R 和0.5mL 0.01M依地酸钠。有纯蓝色生成。

Residue on evaporation: maximum 0.001 per cent.

Evaporate 100mL to dryness on a water-bath and dry in an oven at 100-105℃. The residue weighs a maximum of 1 mg.

蒸发残渣：不应超过0.001%

在水浴中以将100mL 本品蒸发至恒重，并在烘箱中以100-105℃进行干燥。残渣重量不得超过1mg 。

Microbial contamination

TAMC: acceptance criterion 102 CFU/mL (2.6.12). Use casein soya bean

digest agar.

微生物污染

好氧微生物总数检查法：验收标准≤102 CFU/mL (2.6.12)。使用大豆酪蛋白消化琼脂。

LABELLING

The label states, where applicable, that the substance is suitable for 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。

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