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, 74.5

SPECIFICATIONS标准 Tests检测项目 Appearance外观 Identification 鉴别 A(Chemical reaction) A. 化学反应 B(chemical reaction) B.化学反应 Appearance of solution 溶液外观 Acidity or alkalinity 酸碱性 Bromides 溴化物 Iodates 碘化物 Sulphates 硫化物 Aluminium 铝 Barium 钡 Iron 铁 Magnesium and alkaline-earth metals 镁和碱土金属 Sodium 钠 Loss on drying 干燥失重 Assay 含量

Acceptance criteria合格标准 White or almost white, crystalline powder or colourless crystals. 白色或近白色晶体粉末或无色晶体 Positive reaction 正反应 Positive reaction 正反应 The solution is clear and colourless. 溶液呈澄清无色 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. 不超过0.5 mL 0.01 M盐酸或0.01 M 氢氧化钠使指示剂变色 Maximum 0.1 percent. 最大值0.1% No blue colour develops. 不产生蓝色 Maximum 300 ppm. 最大值300 ppm Maximum 1.0 ppm 最大值1.0 ppm 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. 溶液产生的沉淀不得浓于5 mL溶液S和6 mL蒸馏水 Maximum 20 ppm. 最大值20 ppm Maximum 200 ppm. 最大值200 ppm Maximum 0.1 percent. 最大值0.1% Not more than 1.0%. 不超过1.0% 99.0 percent to 101.0 percent of KCl (dried substance). 99.0~101.0% Test 检测 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1.0ppm

Prescribed 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10mlPH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, determined

on 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。 ASSAY

Dissolve 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

1×0.1×10×W

×100

V―― volume of 0.1M ammonium thiocyanate consumed, 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/L

C2―― 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.