主题:【原创】EP6.3纯化水中英对照

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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。

是生产透析溶液,还是用作透析溶液?
何当奇
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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:无色透明液体。

definition没翻译
何当奇
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TESTS
It complies with the tests prescribed in the section on Purified water in bulk and with the following additional 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。

additional 另外的,额外的 没翻译出来
何当奇
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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,不得显红色;另取10ml,加溴麝香草酚蓝指示液5滴,不得显蓝色。

楼主对内容进行了修正,很明显。
就是对那个体积不太理解。不同的指示液每滴的体积不一样吗?
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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,溶液仍然显粉红色。
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。

没有发生变化  改为不发生变化,会不会好点?
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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碱性碘化汞钾溶液,与4ml铵标准溶液(1ppm NH4)加无氨的水16ml与碱性碘化汞钾溶液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,样品溶液的颜色不得比对照液更深。

这样翻译很好,简洁明了。比原文更顺畅
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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,有纯蓝色生成。
Residue on evaporation: maximum 0.001 per cent. Evaporate 100 ml to dryness on a water-bath and dry in an oven at 100-105 °C. The residue weighs a maximum of 1 mg.
不挥发物:取本品100ml,置已于100-105℃中烘至恒重的蒸发皿中,在水浴上蒸干,并在100-105℃的烘箱中干燥至恒重,遗留残渣不得过1mg

不挥发物里:少了最大0.001%
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影子
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原文由 redanqi 发表:
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.
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。这句话有待商讨

这句话确实不太好翻译,所以我借鉴了中国药典2005年版上的原话
何当奇
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原文由 hyheying 发表:
原文由 redanqi 发表:
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.
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。这句话有待商讨

这句话确实不太好翻译,所以我借鉴了中国药典2005年版上的原话

因为我觉得原句里有因果关系,而翻译里面没有。
使用种批培养维持技术(种批系统)以使.....
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