欧盟药典-纯化水
WATER, PURIFIED
Aqua purificata
Purified water in bulk 散装纯化水
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：在生产和贮存过程中，应进行适当的检测以确保水的微生物数被足够地控制与监控。设
置适当的警戒限与行动限以便于发现不利的趋势。在正常条件下，微生物数的警戒限是100CFU/ml，
用不大于0.45 μm的微孔滤膜过滤后使用R2A琼脂，在30-35°C培养至少5天后计数。检测样品量的多少
根据规定指标进行选择。
R2A agar
Yeast extract 0.5 g
Proteose peptone 0.5 g
Casein hydrolysate 0.5 g
g Glucose 0.5
g Starch 0.5 Dipotassium hydrogen phosphate 0.3 g
Magnesium sulphate, anhydrous 0.024 g
Sodium pyruvate 0.3 g
g Agar 15.0 Purified water to 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.
适当调整以使R2A琼脂灭菌之后的pH值为7.2 ± 0.2。通过在121°C高压锅中加热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.
— Growth promotion. Test each batch of ready-prepared medium and each batch of medium, prepared either from dehydrated medium or from the ingredients described.
Inoculate plates of R2A agar separately with a small number (not more than 100 CFU) of the
micro-organisms indicated in Table 0008.-1. Incubate under the conditions described in the table. Growth obtained must not differ by a factor greater than 2 from the calculated value for a standardised inoculum. For a freshly prepared inoculum, growth of the micro-organisms must be comparable to that obtained with a previously tested and approved batch of medium.
R2A琼脂促生长试验
—测试菌珠的准备：使用标准菌悬液或按表0008.-1中指定的方法制备。菌珠传代次数不得超过5
代，并采用适当的菌种保藏技术以保证所使用菌珠的生物学特性。每种菌珠的生长分别按表0008.-1
中描述的程序进行。使用pH7.0的氯化钠蛋白胨缓冲液或pH7.2的磷酸盐缓冲液制备测试菌悬液。制
备好的菌悬液应在2小时内使用，当贮存在2-8 °C时在24小时内使用。也可以通过制备并稀释枯草芽胞杆菌营养细胞的新鲜悬液进行替代，制备稳定的胞子悬液，在接种测试中使用适当体积的胞子菌悬液，稳定的胞子悬液在2-8 °C保存，保存期是经过验证的。
—促生长试验：测试每批已制备好的培养基以及采用脱水培养基制备或按指定的成分制备的培养基。分别将表0008.-1中指定的不超过100CFU的菌悬液（或孢子悬液）接种在R2A琼脂上，按表中指定的条件进行培养。对于新鲜制备的细菌培养液，微生物的生长必须与先前测试过或者已经认可的培养基具有可比性。
Table 0008.-1. – Growth promotion of R2A agar
Micro-organism微生物Preparation of the test
strain测试菌珠的制备Growth promotion促生长试验
Pseudomonas Aeruginosa 铜绿假单胞菌
Such as:
ATCC 9027
NCIMB 8626
CIP 82.118
NBRC 13275Casein soyabean digest
agar or casein soyabean
digest broth
30-35°C
18-24 h
R2A agar
≤ 100 CFU
30-35°C
≤ 3 days
Bacillus sublilis枯草芽胞杆菌
Such as:
ATCC 6633
NCIMB 8054
CIP 52.62
NBPC 3134Casein soyabean digest
agar or casein soyabean
digest broth
30-35°C
18-24 h
R2A agar
≤ 100 CFU
30-35°C
≤ 3 days
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 sulphuric 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质：按2.2.44所描述的方法测试总有机碳，限度为0.5 mg/l；或按下述方法测试易氧化物质：取本品100ml，加稀硝酸10ml及0.02M高锰酸钾滴定液0.1ml，煮沸5分钟，溶液仍然显粉红。
Conductivity. Determine the conductivity off-line or in-line under the following conditions. 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 μS·cm−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.
Conductometer: accuracy of 0.1 μS·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 μS·cm−1. 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.
Temperature measurement : tolerance ± 2 °C.
PROCEDURE
Measure the conductivity without temperature compensation, recording simultaneously the temperature. Temperature-compensated measurement may be performed after suitable validation. 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.
Table 0008.-2. – Temperature and conductivity requirements
Temperature Conductivity
(°C) (μS·cm−1)
0 2.4电导率仪的使用
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.
电导率：按下列条件进行在线或离线电导率测试。
设备：电导池。
一个适当材料（如不锈钢）的电极；
电池常数：电池常数通常被供应商校正，并且以适当的周期使用已经过鉴定的电导率低于1500
μS·cm−1的参照溶液进行确认，或者用一个已经过鉴定的电池常数进行测试比较（标准电极？），如果测得值在给定值的2%以内则此电池常数符合规定，否则应重新校正。
电导率仪：准确度为0.1 μS·cm−1或更低的范围；
系统校正（电导池和电导率仪）：
一个或一个以上的已经过鉴定的参照溶液；
准确度：在被测电导率加0.1 μS·cm−1的3%以内；
电导率仪校正：测量所使用的每一个范围都应被校正，拆下电导池之后，使用被鉴定的精密电阻器，
或带有一个不确定度不超过鉴定值0.1%的同等设备。如果在线电导池不能被拆下，则系统校正应根据
一个已被校正过的电导率-测量设备进行，此电导率-测量设备带有一个电导池，放在将要被校正的电
导池附近，在水流下进行校正。
温度测量：误差± 2 °C
操作程序：在没有温度补偿下测试电导率，同时记录测试温度。在适当的确认之后温度-补偿测量可能
被执行。在所记录的温度下测得的电导率不超过表0008.-2中的值则被检测水的电导率符合要求。
表 0008.-2. – 温度和电导率要求
温度(°C) 电导率(μS·cm−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 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：如果散装纯化水电导率符合散装注射用水项下的电导率要求则不需要进行重金属测试。CHARACTERS
Appearance: clear and colourless liquid.
外观：无透明液体。
TESTS
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 sulphuric 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 NO3) R.
硝酸盐：取本品5ml置试管中，于冰浴中冷却，加100g/l氯化钾溶液0.4ml与0.1%二苯胺溶液
0.1ml，边摇边滴加无氮的硫酸5ml，摇匀，将试管于50℃水浴中放置15分钟，溶液产生的蓝与标
准硝酸盐溶液(2 ppm NO3)0.5ml，加无硝酸盐的水4.5ml，在同一时间用同一方法处理后的颜比较，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.
铝盐：如果作为透析溶液使用，其值应不超过10ppb。
指定溶液：取本品400ml，加10mlpH6.0的醋酸盐缓冲液及100ml蒸馏水，混合。
参照溶液：取2ml铝标准溶液(2 ppm Al)，加10mlpH6.0的醋酸盐缓冲液及98ml蒸馏水，混合。
空白溶液：取10mlpH6.0的醋酸盐缓冲液及100ml蒸馏水，混合。
将上述三种溶液按2.4.17项下描述的方法进行比较测试。
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：取本品200ml，加0.1M硝酸滴定液0.15ml，置一玻璃蒸发皿中水浴加热直至体积减少至
20ml，放冷后，取此溶液12ml按测试A进行。
参照溶液：取10ml标准铅溶液(1ppm Pb)，加0.1M硝酸滴定液0.075ml，按测试A进行。
空白溶液：取0.1M硝酸滴定液0.075ml，按测试A进行。
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：如果作为透析溶液使用，且在生产中没有进行适当的除细菌内毒素的处理，其值应小于0.25 IU/ml。
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.
CHARACTERS
Appearance : clear and colourless liquid.
外观：无透明液体。
TESTS
It complies with the tests prescribed in the section on Purified water in bulk and with the following ad
ditional tests.
桶装纯化水应符合散装纯化水项下以及下面所描述的测试要求。
Acidity or alkalinity. To 10 ml, freshly boiled and cooled in a borosilicate glass flask, add 0.05 ml of methyl red solution R. The solution is not coloured red.
To 10 ml add 0.1 ml of bromothymol blue solution R1. The solution is not coloured blue.
酸碱度：取本品，置于一硼硅酸玻璃烧瓶中，煮沸并放冷；取冷却后的样品10ml，加甲基红指示液2滴，不得显红；另取10ml，加溴麝香草酚蓝指示液5滴，不得显蓝。
Oxidisable substances. To 100 ml add 10 ml of dilute sulphuric acid R and 0.1 ml of 0.02 M potassium permanganate and boil for 5 min. The solution remains faintly pink.
易氧化物：取本品100ml，加稀硫酸10ml及0.02M高锰酸钾0.1ml，煮沸5分钟，溶液仍然显粉红。
Chlorides. To 10 ml 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 15 min.
氯化物：取本品10ml，加1ml硝酸与0.2ml硝酸银溶液，在至少15分钟内溶液外观没有发生变化。
Sulphates. To 10 ml add 0.1 ml of dilute hydrochloric acid R and 0.1 ml of barium chloride solution R1. The solution shows no change in appearance for at least 1 h.
硫酸盐：取本品10ml，加0.1ml稀盐酸与0.1ml氯化钡溶液，在至少1小时内溶液外观没有发生变化。
Ammonium : maximum 0.2 ppm.
To 20 ml add 1 ml 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 1 ml of alkaline potassium tetraiodomercurate solution R to a mixture of 4 ml of ammonium standard solution (1 ppm NH4) R and 16 ml of ammonium-free water R.
铵盐：取本品20ml，加1ml碱性钾溶液，与4ml铵标准溶液（1ppm NH4）加无氨的水16ml与碱性钾溶液1ml制成的对照液比较。样品溶液与对照液同时制备并放置5分钟后沿试管垂直方向进行观察，样品溶液的颜不得比对照液更深。
Calcium and magnesium. To 100 ml add 2 ml of ammonium chloride buffer solution pH 10.0 R, 50 mg of mordant black 11 triturate R and 0.5 ml of 0.01 M sodium edetate. A pure blue colour is produced.
钙盐和镁盐：取本品100ml，加2mlpH10.0的氯化铵缓冲盐溶液，50mg铬黑11指示剂及0.01M的EDTA滴定液0.5ml，有纯蓝生成。

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