USP氯化钠译文.doc

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。Lab

2、eling 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 dosa

3、ge 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

4、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

5、 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 superna

6、tant 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

7、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 Sodiu

8、m 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

9、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 s

10、olution, 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 materia

11、l at 105 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 ch

12、loramine 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, c

13、oncomitantly 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 1

14、0ml，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 so

15、lution 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 t

16、o 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

17、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

18、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

19、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 Sodiu

20、m Chloride to a 100-mL volumetric flask, add water and swirl to dissolve, dilute with water to volume, and mix. Standard solution NOTEThe 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

21、the instrument. Dissolve 1.144 g of potassium chloride, previously dried at 105 for 3 hours, in water, dilute with water to 1000 mL, and mix. This solution contains the equivalent of 600 g of potassium per mL. Dilute as required to obtain not fewer than three solutions at concentrations that span th

22、e 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 airacetylene flame and a wavelength of 766.5 nm.

23、 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

24、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 solutio

25、n (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

26、 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 wit

27、h 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 25

28、0 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 volumet

29、ric 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 chlo

30、roform 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 so

31、lution 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 g per g). 铝盐：（当氯化钠用于制备腹膜透

32、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。醋酸盐缓冲液（pH=6.0）：取 50g醋酸铵置于 250ml容量瓶中，加水 150ml溶解，用冰乙酸调节 pH值至 6.0，定容至 250ml，混匀。供试液：取供试品 20.0g溶解于 100ml水中，加入 10ml醋酸盐缓冲液（pH=6.0），用 0.5%的8-羟基喹啉氯仿溶液分次提取，体积分别为：20ml，20ml，10ml，合并提取液置于 50ml容量瓶中，用氯仿定容，摇匀。标准溶

33、液：制备标准铝溶液 2.0ml、醋酸盐缓冲液（pH=6.0）10ml 和 98ml水的混合液，照供试液方法，制得 50ml氯仿溶液，混匀。空白液：制备醋酸盐缓冲液（pH=6.0）10ml 和 100ml水的混合液，照供试液方法，制得50ml氯仿溶液，混匀。检查法：于荧光测定仪中测定供试液与标准溶液的荧光强度，激发波长采用 392nm，发射波长采用 518nm，用空白液校零。供试液荧光强度不得大于对照液。（0.2 微克每克）Magnesium and alkaline-earth metals To 200 mL of water add 0.1 g of hydroxylamine hydro

34、chloride, 10 mL of pH 10.0 ammoniaammonium chloride buffer (prepared by dissolving 5.4 g of ammonium chloride in 20 mL of water, adding 20 mL of ammonium hydroxide and diluting to 100 mL), 1 mL of 0.1 M zinc sulfate, and about 0.2 g of eriochrome black T trituration. Heat to about 40. Titrate this s

35、olution with 0.01 M edetate disodium VS until the violet color changes to deep blue. To this solution add 10.0 g of Sodium Chloride dissolved in 100 mL of water. If the color changes to violet, titrate the solution with 0.01 M edetate disodium VS to a deep blue endpoint. The volume of 0.01 M edetate

36、 disodium consumed in the second titration does not exceed 2.5 mL (0.01%, calculated as Ca). 镁和碱金属：于 200ml水中加入 0.1g盐酸羟胺，10ml 铵-氯化铵缓冲液（pH=10.0）取5.4g氯化铵溶解于 20ml水中，加入 20ml氨水，定容至 100ml，1ml0.1M 硫酸锌和约 0.2g铬黑 T粉末。加热到 40，用 0.01MEDTA滴定液滴定至溶液显深蓝色。再向溶液中加入100ml含 10.0g样品的水溶液，如果溶液颜色变紫，用 0.01M的 EDTA滴定液滴定至深蓝色，第二次滴定

37、的体积不得过 2.5ml。（0.01%以钙计）Arsenic, Method I 211 : 1 g per g. 砷盐：依照方法 I检查，应不大于 0.0001%（参照中国药典 2010版）Iron Test solution Use a 10-mL portion of the solution prepared for the test for Appearance of solution. Standard solution Immediately before use, dilute Standard Iron Solution (see Iron 241 ) 1 to 10 wit

38、h water. This solution contains the equivalent of 1 g of iron per mL. Combine 4 mL of this solution and 6 mL of water. Procedure To each of the solutions, add 2 mL of a 200 g per L solution of citric acid and 0.1 mL of thioglycolic acid. Mix, make alkaline with stronger ammonia water, and dilute wit

39、h water to 20 mL. After 5 minutes, any pink color in the Test solution is not more intense than that from the Standard solution. The limit is 2 g per g. 铁盐：供试液：取 10ml溶液性状项下溶液。标准溶液：临用现配，取标准铁溶液（参照铁盐检查法）1.0ml，用水定容至 10ml，此溶液 1ml相当于 1微克铁。取 4ml此溶液加 6ml水混合。检查法：向每种溶液中加入 2ml200g/L的柠檬酸和 0.1ml巯基乙酸，混匀。用浓氨水碱化，稀释

40、至 20ml。放置 5分钟，供试液颜色不得深于标准溶液的颜色（粉红）。（2 微克每克）Barium To 5 mL of the solution prepared for the test for Appearance of solution, add 2 mL of 2 N sulfuric acid and 5 mL of water. To another 5 mL of the solution prepared for the test for Appearance of solution, add 7 mL of water. The solutions are equally

41、clear after standing for 2 hours. 钡盐：于 5ml溶液性状项下溶液中加入 2ml2N的硫酸和 5ml水。另取 5ml溶液性状项下溶液加 7ml水，2 小时内均不得浑浊。Ferrocyanides Dissolve 2.0 g in 6 mL of water. Add 0.5 mL of a mixture of 5 mL of ferric ammonium sulfate solution (1 g in 100 mL of 0.1 N sulfuric acid) and 95 mL of ferrous sulfate solution (1 in 1

42、00): no blue color develops in 10 minutes. 亚铁氰化物：取本品 2.0g溶解于 6ml水中，加入 0.5ml混合液（混合液：5ml 硫酸铁铵1g溶解于 100ml0.1N硫酸和 95ml硫酸亚铁1g 溶解于 100ml水中），10 分钟内不得显蓝色。Sulfate Standard sulfate solution A To 181 mg of potassium sulfate in a 100-mL volumetric flask, add a few mL of 30% alcohol, swirl to dissolve, dilute wi

43、th 30% alcohol to volume, and mix. Immediately before use, transfer 10.0 mL of this solution to a 1000-mL volumetric flask, dilute with 30% alcohol to volume, and mix. This solution contains 10 g of sulfate per mL. Standard sulfate solution B To 181 mg of potassium sulfate in a 100-mL volumetric fla

44、sk, add a few mL of water, swirl to dissolve, dilute with water to volume, and mix. Immediately before use, transfer 10.0 mL of this solution to a 1000-mL volumetric flask, dilute with water to volume, and mix. This solution contains 10 g of sulfate per mL. Sodium chloride solution Dissolve 2.5 g of

45、 Sodium Chloride in 50 mL of water. Procedure To 1.5 mL of Standard sulfate solution A add 1 mL of a barium chloride solution (1 in 4), shake, and allow to stand for 1 minute. To 2.5 mL of the resulting suspension, add 15 mL of the Sodium chloride solution and 0.5 mL of 5 N acetic acid, and mix (Tes

46、t solution). Prepare the Standard solution in the same manner, except use 15 mL of Standard sulfate solution B instead of the Sodium chloride solution: any turbidity produced in the Test solution after 5 minutes standing is not greater than that produced in the Standard solution (0.020%). 硫酸盐：标准硫酸盐溶

47、液 A：称取 181mg硫酸钾置于 100ml容量瓶中，加入数 ml30%乙醇，旋转振摇使溶解，再以 30%乙醇定容，混匀。（作为储备液），临用前，取 10ml储备液，用 30%的乙醇定容至 1000ml，混匀，制得 10微克/ml 的标准硫酸盐溶液 A。标准硫酸盐溶液 B：将溶剂换为水，处理过程同标准硫酸盐溶液 A。氯化钠溶液：称取 2.5g氯化钠溶解于 50ml水中。检查过程：取 1.5ml标准硫酸盐溶液 A加入 1ml氯化钡溶液（25%）,摇匀，静置 1分钟，然后再加入 15ml氯化钠溶液和 0.5ml5N的乙酸，混匀，作为供试液。同法制备对照液，其中用标准硫酸盐溶液 B代替氯化钠溶液。

48、放置 5分钟后，供试液浑浊程度不得大于对照液。Nitrites To 10 mL of the solution prepared in the test for Appearance of solution, add 10 mL of water, and measure the absorbance of the solution in a 1-cm cell at 354 nm. The absorbance is not greater than 0.01. 亚硝酸盐：取 10ml溶液性状项下溶液，加入 10ml水，用液层厚度 1cm比色皿，在 354nm处测定吸光度，不得大于 0.0

49、1.Heavy metals, Method I 231 : 5 ppm. 重金属：不得过 5ppm（参照中国药典）Assay Dissolve 50 mg of Sodium Chloride, accurately weighed, in water, and dilute with water to 50 mL. Titrate with 0.1 N silver nitrate VS, determining the endpoint potentiometrically (see Titrimetry 541 ). Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl. 含量测定： 精密称取 50mg供试品溶解入水中，定容至 50ml，用 0.1N硝酸银滴定液滴定，滴定终点参照滴定分析法中相关规定，每 ml硝酸银滴定液相当于 5.844mg氯化钠。Auxiliary Information Please check for your question in the FAQs before contacting USP. Topic/Question