BP2009氯化钾药典.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Potassium Chloride Potassium Chloride General Notices (Ph Eur monograph 0185) KCl74.6 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 100.5 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 ©Crown Copyright 2006 1 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 thiosulphate