USP氯化钠译文

Sodium Chloride 氯化钠 NaCl

58.44

Sodium Chloride

Sodium Chloride [7647-14-5].

? Sodium Chloride contains not less than 99.0 percent and not more than 100.5 percent of NaCl, calculated on the dried basis.

氯化钠按干燥品计算，含氯化钠应不少于99%不高于100.5%。 Packaging and storage— Preserve in well-closed containers. 包装与贮藏：密封保存。

Labeling— Where Sodium Chloride is intended for use in the manufacture of injectable dosage forms, peritoneal dialysis solutions, hemodialysis solutions, or

hemofiltration solutions, it is so labeled. Where Sodium Chloride must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of Bacterial endotoxins, it is so labeled. Where Sodium Chloride is sterile, it is so labeled.

以下情况均需注明：氯化钠应用于注射剂、腹膜透析溶液、血液透析液和血液过滤液的生产；氯化钠经过进一步加工应用于注射剂型时的细菌内毒素可接受水平；无菌情况。

Appearance of solution— Dissolve 20.0 g of Sodium Chloride in carbon dioxide-free water, and dilute with the same solvent to 100.0 mL. This solution is clear and colorless.

溶液性状：将本品20.0g溶解于去二氧化碳水中，定容至100.0ml，溶液应澄清无色。 Identification— It responds to the tests for Sodium 191 and for Chloride. 鉴别：应与钠盐和氯化物鉴别一致。

Chloride— Dissolve about 3 mg of Sodium Chloride in 2 mL of water. Acidify with diluted nitric acid and add 0.4 mL of silver nitrate TS. Shake, and allow to stand. A curdled, white precipitate is formed. Centrifuge, wash the precipitate with three 1-mL portions of water, and discard the washings. Carry out this operation rapidly in subdued light, disregarding the fact that the supernatant may not become perfectly clear. Suspend the precipitate in 2 mL of water and add 1.5 mL of 10 N ammonium hydroxide. The precipitate dissolves easily with the possible exception of a few large particles, which dissolve more slowly.

氯化物：将本品3mg溶解于2ml水中，用适量稀硝酸酸化后，加入0.4ml硝酸银试液，振摇，静置，离心，弃去上清液，沉淀用1ml水分3次洗涤，弃去洗涤剂（洗涤液如有浑浊可不计）。加入2ml水将沉淀悬浮，再加入1.5ml 10N 的氨水，沉淀迅速溶解，大块的沉淀物溶解较为缓慢。此操作应快速且避光。

Bacterial endotoxins 85— The level of Bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Sodium Chloride

is used can be met. Where the label states that Sodium Chloride must be subjected to further processing during the preparation of injectable dosage forms, the level of Bacterial endotoxins are such that the requirement under the relevant dosage form monograph(s) in which Sodium Chloride is used can be met.

细菌内毒素：细菌内毒素水平应参照氯化钠的应用剂型要求。经加工应用于注射剂的氯化钠，应符合相关剂型专著的要求。

Sterility 71— Where the label states that Sodium Chloride is sterile, it meets the requirements for Sterility under the relevant dosage form monograph(s) in which Sodium Chloride is used. 无菌：应符合相应剂型的无菌要求。

Acidity or alkalinity— To 20 mL of the solution prepared for the test for Appearance of solution, add 0.1 mL of bromothymol blue TS: not more than 0.5 mL of 0.01 N hydrochloric acid or 0.01 N sodium hydroxide is required to change the color of this solution.

酸碱度：取20ml溶液性状项下溶液，加入0.1ml麝香草芬兰试液，加入至多0.5ml0.01N盐酸溶液或0.01N氢氧化钠溶液，溶液颜色均应改变。（参照中国药典2010版）

Loss on drying 731— Dry the test material at 105o for 2 hours: it loses not more than 0.5% of its weight, determined on a 1.000 g sample. 干燥失重：精密称取本品约1g在105℃干燥2小时，减失重量不得过0.5%。

Limit of bromides— To 0.5 mL of the solution prepared for the test for Appearance of solution, add 4.0 mL of water, 2.0 mL of pH 4.7 phenol red TS, and 1.0 mL of chloramine T solution (0.1 mg per mL), and mix immediately. After 2 minutes, add 0.15 mL of 0.1 N sodium thiosulfate, mix, dilute with water to 10.0 mL, and mix. The absorbance of this solution measured at 590 nm, using water as the comparison liquid, is not greater than that of a Standard solution, concomitantly prepared, using 5.0 mL of a solution containing 3.0 mg of potassium bromide per L and proceeding as above, starting with the addition of 2.0 mL of pH 4.7 phenol red TS (0.010%). 溴化物：取0.5ml溶液性状项下溶液，加入4.0ml水、2mlpH值为4.7的酚红试液和1.0ml 0.1mg/ml氯胺T溶液，迅速混合。2分钟后加入0.15ml0.1N硫代硫酸钠，混匀，用水定容至10ml，混匀后，在590nm处测定吸光度，用水做对照液，不得大于与用5ml3.0mg/L的溴化钾溶液同法制成的对照液的吸光度。(0.010%) Limit of phosphates—

Phosphate stock standard solution— Dissolve an accurately weighed quantity of

monobasic potassium phosphate in water to obtain a solution having a concentration of about 0.716 mg per mL.

Phosphate standard solution— Dilute 1 mL of the Phosphate stock standard solution

with water to 100 mL. Prepare this solution fresh.

Standard solution— Dilute 2 mL of the Phosphate standard solution with water to

100 mL.

Test solution— Dilute 2 mL of the solution prepared in the test for Appearance of solution with water to 100 mL.

Procedure— To the Standard solution and the Test solution, add 4 mL of Sulfomolybdic acid solution, and add 0.1 mL of a mixture of 1 mL of stronger acid stannous chloride

TS and 10 mL of 2 N hydrochloric acid. After 10 minutes, compare the colors of 20 mL of each solution: any color in the Test solution is not more intense than that in the Standard solution (0.0025%).

Sulfomolybdic acid solution— Dissolve with heating 2.5 g of ammonium molybdate in

20 mL of water. Dilute 28 mL of sulfuric acid with 50 mL of water, then cool. Mix the two solutions, and dilute with water to 100 mL.

磷酸盐：标准磷酸盐储备溶液：用适宜的方法制得每ml含有0.716mg的磷酸二氢钾的水溶液。

标准磷酸盐溶液：临用现配，取1ml储备液用水定容至100ml。 标准溶液：取标准磷酸盐溶液2ml用水定容至100ml。 供试液：取2ml溶液性状项下溶液用水定容至100ml。

检查过程：向标准溶液及供试液中分别加入4.0ml Sulfomolybdic acid（磺化钼酸）溶液（Sulfomolybdic acid溶液：称取2.5g钼酸铵溶解于20ml水中，再将28ml硫酸定容至50ml，放冷，将上述2种溶液混合定容至100ml，即得。），然后再加入0.1ml混合液（混合液：1ml酸性氯化亚锡试液与10ml2N盐酸）。放置10分钟，将2份溶液于20ml比色皿中比较：供试液管颜色不得深于标准管中的颜色。（0.0025%）

Limit of potassium (where it is labeled as intended for use in the manufacture of injectable dosage forms, peritoneal dialysis solutions, hemodialysis solutions, or hemofiltration solutions)—

Test solution— Transfer 1.00 g of Sodium Chloride to a 100-mL volumetric flask,

add water and swirl to dissolve, dilute with water to volume, and mix.

Standard solution— [NOTE—The Standard solution and the Test solution may be

modified, if necessary, to obtain solutions of suitable concentrations adaptable to the linear or working range of the instrument.] Dissolve 1.144 g of potassium chloride, previously dried at 105o for 3 hours, in water, dilute with water to 1000 mL, and mix. This solution contains the equivalent of 600 μg of potassium per mL. Dilute as required to obtain not fewer than three solutions at concentrations that span the expected value in the Test solution.

Procedure— Using atomic absorption spectrophotometry (see Spectrophotometry and Light-Scattering 851), measure, at least three times, the emission intensity

of the Test solution and the Standard solution using an air–acetylene flame and a wavelength of 766.5 nm. Prepare a calibration curve from the mean of the readings obtained with the Standard solution, and determine the concentration of potassium in the Test solution. The limit is 0.05%.

钾：（标注用于注射剂、腹膜透析、血液透析或血液过滤应检查此项） 供试液：取1.00g样品用水溶解，定容至100ml。

对照液：（注意：如必要，对照液与供试液的浓度可以根据线性要求和仪器要求改变。）取1.144g在105℃下干燥3小时的氯化钾，用水定容至1000ml，混匀。此溶液每ml含600微克钾。根据需求用此溶液稀释不同级别浓度的溶液，浓度级别数目应不小于3个。 检查法：采用原子吸收分光光度法（参照分光光度法、光散射法），在766.5nm处，至少测定3次，采用对照液获得的吸光度和钾离子浓度做标准曲线，于标准曲线中计算供试液中钾浓度，不得大于0.05%。

Iodides— Moisten 5 g of Sodium Chloride by the dropwise addition of a freshly prepared mixture of 0.15 mL of sodium nitrite solution (1 in 10), 2 mL of 1 N sulfuric acid, 25 mL of iodide-free starch TS, and 25 mL of water. After 5 minutes, examine the substance in natural light. No blue color is observed.

碘化物：用混合液（混合液：0.15ml10%的亚硝酸钠溶液，2ml1N的硫酸，25ml淀粉指示液与25ml水）逐滴湿润样品。5分钟后，自然光下观察不得显蓝色。

Aluminum (where it is labeled as intended for use in the manufacture of peritoneal dialysis solutions, hemodialysis solutions, or hemofiltration solutions)—

Standard aluminum solution— To 352 mg of aluminum potassium sulfate in a 100-mL

volumetric flask, add a few mL of water, swirl to dissolve, add 20 mL of diluted sulfuric acid, dilute with water to volume, and mix. Immediately before use, transfer 1.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix.

pH 6.0 Acetate buffer— Dissolve 50 g of ammonium acetate in 150 mL of water, adjust

with glacial acetic acid to a pH of 6.0, dilute with water to 250 mL, and mix.

Test solution— Dissolve 20.0 g of Sodium Chloride in 100 mL of water, and add 10 mL of pH 6.0 Acetate buffer. Extract this solution with successive portions of 20,

20, and 10 mL of a 0.5% solution of 8-hydroxyquinoline in chloroform, combining the chloroform extracts in a 50-mL volumetric flask. Dilute the combined extracts with chloroform to volume, and mix.

Standard solution— Prepare a mixture of 2.0 mL of Standard aluminum solution, 10 mL of pH 6.0 Acetate buffer, and 98 mL of water. Extract this mixture as described for the Test solution, dilute the combined extracts with chloroform to volume, and

mix.

Blank solution— Prepare a mixture of 10 mL of pH 6.0 Acetate buffer and 100 mL of water. Extract this mixture as described for the Test solution, dilute the combined

extracts with chloroform to volume, and mix.

Procedure— Determine the fluorescence intensities of the Test solution and the Standard solution in a fluorometer set at an excitation wavelength of 392 nm and an emission wavelength of 518 nm, using the Blank solution to set the instrument to zero. The fluorescence of the Test solution does not exceed that of the Standard solution (0.2 μg per g).

铝盐：（当氯化钠用于制备腹膜透析液、血液透析液及血液过滤液时，应检查此项。） 标准铝溶液：取352mg硫酸钾铝，用少量水振摇溶解，加入20ml稀硫酸，用水定容至100ml，混匀。临用前，取1.0ml此溶液用水定容至100ml，混匀。