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01/2008:0193 corrected 7,0
SODIUM CHLORIDE
Natrii chloridum
NaCI M, 58.44
[7647-14-5]
DEFINITION
Content. 99.0 per cent to 100.5 per cent (dried substance). CHARACTERS
Appearance, white or almost white, crystalline powder or colourless crystals or white or almost white pearls.
Solubility: freely soluble in water, practically insoluble in anhydrous ethanol.
IDENTIFICATION
A. It gives the reactions of chlorides {2.3.I).
B. It gives the reactions of sodium (2.3.1).
TESTS
Solution S. Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R and dif utE to 100.0 mL with the same solvent.
Appearance of solution. Solutions is clear (2.2.1) and colourless (2.2.2, Method IF).
Acidity or alkalinity. To 20 mL of solution S add 0.1 mL of bromothymoi Hue solutionRl. 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.
Bromides: 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 lOmLofa 0.1 g/L solution of chloramineR and mix immediately. After exactly 2 min, add 0.15 mL of 0.1 M sodium thiosulfate, mix and dilute to lO.OmL 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
Ferrocyanidea 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 sulfate R in a 2.5 g/L solution of sulfuric acid R and 95 mL of a 10 g/L solution of'ferrous sulfate R. No blue colour develops within 10 min.
Iodides. 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 sulfuric 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.
Nitrites. 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.
Sulfates (2.4,13): maximum 200ppm.
Dilute 7.5 mL of solution S to 30 mL with distilledwater R.
Aluminium (2.4.17): maximum 0.2 ppm, if intended for use in the manufacture of peritoneal dialysis solutions, haemodialysis solutions or haemofiltration solutions.
Prescribed solution Dissol ve 20.0 g in 100 mL of water R and add 10 m L of acetate buffer solution pH6.0R.
Reference solution. Mix 2 mL of aluminium standard solution (2 ppm Al) R, lOmLof acetate buffer solution pH 6.0 R and 98 mL of water R.
Blank solution Mix 10 mL of acetate buffer solution pH6.0 R and 100 mL of water R.
Arsenic (2.4.2, Method A): maximum I ppm, determined on 5 mL of solution S.
Barium. To 5 mL of solution S add 5 mL of distilled water R and 2 mL of dilute sulfuric 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 waer R.
Iron (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.
Magnesium and alkaline-earth metals (2.4.7): maximum 100 ppm, calculated as Ca and determined on lO.Og.
Use 150 mg of mordant black 11 triturate R. The volume of 0.0! M sodium edetate used is not more than 2.5 mL.
Potassium: maximum 500 ppm, if intended for use in the manufacture of parenteral preparations or haemodialysis, haemofiltration or peritoneal rJalysis solutions. Atomic emission spectrometry (2.2.22, Method 1).
Test solution. Dissolve 1 00 g in water R and dilute to 100.0 mL with the same solvent.
Reference solutions Dissolve 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 jig of K per millilitre). Dilute as
required.
Wavelength. 766.5 nm.
Heavy metals(2.4.8): maximum 5 ppm.
12 mL of solution S complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R.
Loss on drying (2.2.32): maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105°Cfor2h.
ASSAY
Dissolve 1.0000 g in water R and dilute to tOO.O mL with the same solvent. To 10 mL of the solution add 50 mL of water R, 5 mL of divte nitric acid R, 25 mL of 0.1 M silver nitrate and 2 mL of dibutyl phthalate R. Shake. Titrate with 0.1 M ammonium thiocyanate, using 2 mL offerric amonium sulfate solution R2 as indicator and shaking vigorously towards the end-point
1 mL of 0.1 M silver nitrate is equivalent to 5.844mg of Nad
Phosphates (2.4.11): maximum 25 ppm.
Dilute 2 mL of solution S to 100 mL with water R.