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1、Sodium Chloride 氯化钠NaCl 58.44Sodium 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。Label
2、ing 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
3、 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 di
4、lute 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 nit
5、ric 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
6、 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
7、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
8、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。St
9、erility 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, ad
10、d 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 105 for 2 h
11、ours: 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
12、(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 prepare
13、d, 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
14、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 Phosp
15、hate 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 Stan
16、dard 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
