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同EP9.0 KCl
Potassium Chloride
General Notices
(Ph. Eur. monograph 0185)
KCl 74.6 7447-40-7 
Action and use
Used in prevention and treatment of potassium deficiency and electrolyte imbalance.
Preparations
Bumetanide and Prolonged-release Potassium Tablets
Oral Rehydration Salts
Sterile Potassium Chloride Concentrate
Potassium Chloride and Glucose Intravenous Infusion
Potassium Chloride and Sodium Chloride Intravenous Infusion
Potassium Chloride, Sodium Chloride and Glucose Intravenous Infusion
Potassium Chloride Oral Solution
Prolonged-release Potassium Chloride Tablets
Ph Eur
DEFINITION
Content
99.0 per cent to 101.0 per cent of KCl (dried substance).
CHARACTERS
Appearance
White or almost white, crystalline powder or colourless crystals.
Solubility
Freely soluble in water, practically insoluble in anhydrous ethanol.
IDENTIFICATION
A. It gives the reactions of chlorides (2.3.1).
B. Solution S (see Tests) gives the reactions of potassium (2.3.1).
TESTS
Solution S
Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100 mL with the same solvent.
Appearance of solution
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).
Acidity or alkalinity
To 50 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.
Bromides
Maximum 0.1 per cent.
Dilute 1.0 mL of solution S to 50 mL with water R. To 5.0 mL of the solution add 2.0 mL of phenol red solution R2 and 1.0 mL of chloramine solution R1 and mix immediately. After exactly 2 min add 0.15 mL of 0.1 M sodium thiosulfate, 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 mL of a 3.0 mg/L solution of potassium bromide R.
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 substance shows no blue colour.
Sulfates (2.4.13)
Maximum 300 ppm.
Dilute 5 mL of solution S to 15 mL with distilled water R.
Aluminium (2.4.17)
Maximum 1.0 ppm, if intended for use in the manufacture of haemodialysis solutions.
Prescribed solution Dissolve 4 g in 100 mL of water R and add 10 mL of acetate buffer solution pH 6.0 R.
Reference solution Mix 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 solution Mix 10 mL of acetate buffer solution pH 6.0 R and 100 mL of water R.
Barium
To 5 mL of solution S add 5 mL of distilled water R and 1 mL of dilute sulfuric acid R. After 15 min, any opalescence in the solution is not more intense than that in a mixture of 5 mL of solution S and 6 mL of distilled water R.
Iron (2.4.9)
Maximum 20 ppm.
Dilute 5 mL of solution S to 10 mL with water R.
Magnesium and alkaline-earth metals (2.4.7)
Maximum 200 ppm, calculated as Ca, determined on 10.0 g using 0.15 g of mordant black 11 triturate R. The volume of 0.01 M sodium edetate used does not exceed 5.0 mL.
Sodium
Maximum 0.1 per cent, if intended for use in the manufacture of parenteral preparations or haemodialysis solutions.
Atomic emission spectrometry (2.2.22, Method I).
Test solution Dissolve 1.00 g of the substance to be examined in water R and dilute to 100.0 mL with the same solvent.
Reference solutions Prepare the reference solutions by diluting as required a solution containing 200 μg of Na per millilitre, prepared as follows: dissolve in water R 0.5084 g of sodium chloride R, previously dried at 105 °C for 3 h, and dilute to 1000.0 mL with the same solvent.
Wavelength 589 nm.
Heavy metals (2.4.8)
Maximum 10 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 1.0 per cent, determined on 1.000 g by drying in an oven at 105 °C for 3 h.
ASSAY
Dissolve 60.0 mg in water R, add 5 mL of dilute nitric acid R and dilute to 50 mL with water R. Titrate with 0.1 M silver nitrate, determining the end-point potentiometrically (2.2.20).
1 mL of 0.1 M silver nitrate is equivalent to 7.46 mg of KCl.
LABELLING
The label states:
— where applicable, that the substance is suitable for use in the manufacture of parenteral preparations;
— where applicable, that the substance is suitable for use in the manufacture of haemodialysis solutions.
Ph Eur
Potassium chloride EP9.0.pdf
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