氯化钾《欧洲药典》9.0中英对照

氯化钾欧洲药典9.0中英对照Potassium chloride氯化钾（KCl）KCl, 74.5SPECIFICATIONS标准Appearance 外观White or almost white, crystalline powder or colourless crystals.白色或进白色晶体粉末或无色晶体IDENTIFICATION鉴别A.It gives the reactions of chlorides (2.3.1).和氯化物反应B.Solution S (see Tests) gives the reactions of potassium.溶液和钾反应TESTS检测Solution S. Dissolve 10.0g in carbon dioxide-free water R prepared from water R and dilute to 100 ml with the same solvent.溶液S. 将10.0g 溶于脱二氧化碳水并稀释至100ml。

Appearance of solution. Solution S is clear (2.2.1) and colourless (2.2.2, Method Ⅱ).溶液外观：溶液呈无色澄清Acidity or alkalinity.To 50 ml of solution S add 0.1 ml of bromothymol blue solution R1. Not more than 0.5 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator.酸碱性：取50ml溶液S加入0.1ml酚蓝溶液，不超过0.5ml 0.01M盐酸或0.01M氢氧化钠使指示剂变色。

Bromides: maximum 0.1 percent.Dilute 1.0 ml of solution S to 50 ml with water R. To 5.0 ml of the solution add 2.0 ml of phenol red solution R2 and 1.0 ml of chloramine solution R1 and mix immediately. After exactly 2 min add 0.15 ml of 0.1 M sodium thiosulphate, mix and dilute to 10.0 ml with water R. The absorbance (2.2.25) of the solution measured at 590 nm, using water R as the compensation liquid, is not greater than that of a standard prepared at the same time and in the same manner using 5 ml of a 3.0 mg/l solution of potassium bromide R.溴化物：取1.0ml溶液S用水稀释至50ml，取5.0ml该溶液加入2.0ml酚红溶液和1.0ml氯胺溶液并立即混合。

2min后加入0.15ml 0.1M硫代硫酸钠混合并用水稀释至10.0ml。

溶液在590nm处用水作对比液的吸收不超过同时用5ml 3.0mg/l溴化钾标准溶液。

Iodides. Moisten 5 g by the dropwise addition of a freshly prepared mixture of 0.15 ml of sodium nitrite solution R, 2 ml of 0.5 M sulphuric acid, 25 ml of iodide-free starch solution R and 25 ml of water R. After 5 min, examine in daylight. The substance shows no blue colour.碘化物：用0.15ml用硝酸钠，2ml 0.5M硫酸和25ml脱碘淀粉新配制的混合溶液浸湿5g样品。

5分钟后在日光下检测，样品不得显示蓝色。

Sulphates (2.4.13): maximum 300 ppm.Dilute 5 ml of solution S to 15 ml with distilled water R.硫化物(2.4.13)：取5ml样品溶液用蒸馏水稀释至15ml。

Aluminium(2.4.17): maximum 1.0ppm, if intended for use the manufacture of haemodialysis solution铝(2.4.17):用于血液透析的溶液最大限度1.0ppmPrescribed solution. Dissolve 4 g in 100 ml of water R and add 10 ml of acetate buffer solution PH 6.0 R.样品溶液：取4g样品溶于100ml水并加入10ml PH为6的乙酸缓冲溶液。

Reference solution. Mix 2 ml of aluminium standard solution(2 ppm Al) R, 10 ml of acetate buffer solution PH 6.0R and 98 ml of water R标准溶液：取2ml铝标准溶液（铝2ppm）和10ml PH为6的乙酸缓冲溶液及98ml水混合配制而成。

Blank solution: Mix 10 ml of acetate buffer solution PH 6.0 R and 100ml of water R空白溶液：将10ml PH为6的乙酸缓冲溶液于100ml水混合配制而成。

Barium. To 5 ml of solution S add 5 ml of distillled water R and 1 ml of dilute sulphuric acid R. After 15 min, any opalescence in the solution is not more intense than that in a mixture of 5 ml of solution S and 6 ml of distilled water R.钡：取5ml溶液S加入5ml蒸馏水和1ml稀硫酸。

15分钟后溶液溶液产生的沉淀不得稠于5 mL溶液S和6 mL蒸馏水。

Iron (2.4.9): maximum 20 ppm.Dilute 5ml of solution S to 10ml with water R铁(2.4.9): 取5ml样品溶液用水稀释至10ml.Magnesium and alkaline-earth metals (2.4.7): maximum 200 ppm, calculated as Ca, determinedon 10.0 g using 0.15 g of mordant black 11 triturate R. The volume of 0.01 M sodium edetate used does not exceed 5.0 ml.镁和其他碱土金属(2.4.7):以钙计最大限值200ppm。

用0.15g铬兰黑11粉末测定10g钙，使铬兰黑11变色的0.01M的依地酸二钠不超过5.0ml。

Sodium: maximum 0.1 percent, if intended for use in the manufacture of parenteral preparation or haemodialysis solution钠：最大限值0.1%。

如果用于注射剂制备或血液透析溶液。

Loss on drying (2.2.32): Not more than 1.0 percent, determined on 1.000 g by drying in an oven at 105 °C for 3 h.干燥失重(2.2.32)：不超过1.0%，取1.000g于干燥箱中在105℃条件下干燥3小时。

ASSAYDissolve 1.300g in water R and dilute to 100.0 ml with the same solvent. To 10.0 ml of the solution add 50 ml of water R, 5 ml of dilute nitric acid R, 25.0 ml of 0.1 M silver nitrate and 2 ml of dibutyl phthalate R. Shake. Titrate with 0.1 M ammonium thiocyanate,using 2 ml of ferric ammonium sulphate solution R2 as indicator and shaking vigorously towards the end-point.1 ml of 0.1 M ammonium thiocyanate is equivalent to 7.46 mg of KCl.含量称取1.300g样品溶于水并稀释至100ml。

取10ml制备好的溶液加入50ml水、5ml稀硝酸、25ml 0.1M硝酸银和2ml酞酸二丁酯，摇匀。

用0.1M硫代氰酸铵滴定并用2ml硫酸铁铵作指示剂下至反应终点。

The assay %(X) of KCl calculated from the following formula:氯化钾含量按下面公式计算：X= (25－C1×V/ C2) ×C2×7.46×100×10-3×1001×0.1×10×WV―― volume of 0.1M ammonium thiocyanate consum ed, ml;0.1M硫代硫氰胺理论消耗体积，ml;C1―― standardized concentration of 0.1M ammonium thiocyanate, mol/l;0.1M硫代硫氰胺理论标准浓度，mol/LC2―― standardized concentration of 0.1 M silver nitrate, mol/L;0.1M硝酸银标准浓度，mol/L W―― weight of the substance examined, g.待测样品重量，g.。