氯化钠（BP2009）

SodiumSodiumSodiumSodium ChlorideChlorideChlorideChloride General Notices (Ph Eur monograph 0193) NaClıı58.44ıı7647-14-5 ActionActionActionAction andandandand useuseuseuse Used in treatment of electrolyte deficiency. PreparationsPreparationsPreparationsPreparations Compound Glucose, Sodium Chloride and Sodium Citrate Oral Solution Oral Rehydration Salts Potassium Chloride and Sodium Chloride Intravenous Infusion Potassium Chloride, Sodium Chloride and Glucose Intravenous Infusion Sodium Chloride Eye Drops Sodium Chloride Eye Lotion Sodium Chloride Intravenous Infusion Sodium Chloride and Glucose Intravenous Infusion Sodium Chloride Irrigation Solution Compound Sodium Chloride Mouthwash Sodium Chloride Oral Solution Sodium Chloride Solution Sodium Chloride Tablets Ph Eur DEFINITIONDEFINITIONDEFINITIONDEFINITION ContentContentContentContent 99.0 per cent to 100.5 per cent (dried substance). CHARACTERSCHARACTERSCHARACTERSCHARACTERS AppearanceAppearanceAppearanceAppearance White or almost white, crystalline powder or colourless crystals or white or almost white pearls. SolubilitySolubilitySolubilitySolubility ©Crown Copyright 2006 1 Freely soluble in water, practically insoluble in anhydrous ethanol. IDENTIFICATIONIDENTIFICATIONIDENTIFICATIONIDENTIFICATION ıA. It gives the reactions of chlorides (2.3.1). ıB. It gives the reactions of sodium (2.3.1). TESTSTESTSTESTSTESTS If the substance is in the form of pearls crush before use. SolutionSolutionSolutionSolution SSSS Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100.0 ml with the same solvent. AppearanceAppearanceAppearanceAppearance ofofofof solutionsolutionsolutionsolution Solution S is clear (2.2.1) and colourless (2.2.2, Method II). AcidityAcidityAcidityAcidity orororor alkalinityalkalinityalkalinityalkalinity To 20 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. BromidesBromidesBromidesBromides Maximum 100 ppm. To 0.5 ml of solution S add 4.0 ml of water R, 2.0 ml of phenol red solution R2 and 1.0 ml of a 0.1 g/l solution of chloramine R 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 5.0 ml of a 3.0 mg/l solution of potassium bromide R. FerrocyanidesFerrocyanidesFerrocyanidesFerrocyanides Dissolve 2.0 g in 6 ml of water R. Add 0.5 ml of a mixture of 5 ml of a 10 g/l solution of ferric ammonium sulphate R in a 2.5 g/l solution of sulphuric acid R and 95 ml of a 10 g/l solution of ferrous sulphate R. No blue colour develops within 10 min. IodidesIodidesIodidesIodides 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 mixture shows no blue colour. NitritesNitritesNitritesNitrites To 10 ml of solution S add 10 ml of water R. The absorbance (2.2.25) is not greater than 0.01 at 354 nm. PhosphatesPhosphatesPhosphatesPhosphates (2.4.11)(2.4.11)(2.4.11)(2.4.11) Maximum 25 ppm. Dilute 2 ml of solution S to 100 ml with water R. ©Crown Copyright 2006 2 Dilute 2 ml of solution S to 100 ml with water R. SulphatesSulphatesSulphatesSulphates (2.4.13)(2.4.13)(2.4.13)(2.4.13) Maximum 200 ppm. Dilute 7.5 ml of solution S to 30 ml with distilled water R. AluminiumAluminiumAluminiumAluminium (2.4.17)(2.4.17)(2.4.17)(2.4.17) Maximum 0.2 ppm, if intended for use in the manufacture of peritoneal dialysis solutions, haemodialysis solutions or haemofiltration solutions. Prescribed solutionıDissolve 20.0 g in 100 ml of water R and add 10 ml of acetate buffer solution pH 6.0 R. Reference solutionıMix 2 ml of aluminium standard solution (2 ppm Al) R, 10 ml of acetate buffer solution pH 6.0 R and 98 ml of water R. Blank solutionıMix 10 ml of acetate buffer solution pH 6.0 R and 100 ml of water R. ArsenicArsenicArsenicArsenic (2.4.2,(2.4.2,(2.4.2,(2.4.2, MethodMethodMethodMethod AAAA)))) Maximum 1 ppm, determined on 5 ml of solution S. BariumBariumBariumBarium To 5 ml of solution S add 5 ml of distilled water R and 2 ml of dilute sulphuric acid R. After 2 h, any opalescence in the solution is not more intense than that in a mixture of 5 ml of solution S and 7 ml of distilled water R. IronIronIronIron (2.4.9)(2.4.9)(2.4.9)(2.4.9) Maximum 2 ppm, determined on solution S. Prepare the standard using a mixture of 4 ml of iron standard solution (1 ppm Fe) R and 6 ml of water R. MagnesiumMagnesiumMagnesiumMagnesium andandandand alkalinealkalinealkalinealkaline----earthearthearthearth metalsmetalsmetalsmetals (2.4.7)(2.4.7)(2.4.7)(2.4.7) Maximum 100 ppm, calculated as Ca and determined on 10.0 g. Use 150 mg of mordant black 11 triturate R. The volume of 0.01 M sodium edetate used is not more than 2.5 ml. Potassium: maximum 5.00 × 102 ppm, if intended for use in the manufacture of parenteral dosage forms or haemodialysis, haemofiltration or peritoneal dialysis solutions. Atomic emission spectrometry (2.2.22, Method I). Test solutionıDissolve 1.00 g in water R and dilute to 100.0 ml with the same solvent. Reference solutionsıDissolve 1.144 g of potassium chloride R, previously dried at 100-105 °C for 3 h, in water R and dilute to 1000.0 ml with the same solvent (600 µg of K per millilitre). Dilute as required. Wavelengthı766.5 nm. HeavyHeavyHeavyHeavy metalsmetalsmetalsmetals (2.4.8)(2.4.8)(2.4.8)(2.4.8) Maximum 5 ppm. 12 ml of solution S complies with test A. Prepare the reference solution using lead standard ©Crown Copyright 2006 3 12 ml of solution S complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R. LossLossLossLoss onononon dryingdryingdryingdrying (2.2.32)(2.2.32)(2.2.32)(2.2.32) Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105 °C for 2 h. BacterialBacterialBacterialBacterial endotoxinsendotoxinsendotoxinsendotoxins (2.6.14)(2.6.14)(2.6.14)(2.6.14) Less than 5 IU/g, if intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for removal of bacterial endotoxins.