USP氯化钠译文..doc

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