Sodium-Acetate-Trihydrate-三水醋酸钠 BP.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Sodium Acetate Trihydrate Sodium Acetate Trihydrate General Notices (Ph Eur monograph 0411) C H NaO ,3H O136.16131-90-4 2 3 2 2 Action and use Used in solutions for dialysis; excipient. Ph Eur DEFINITION Sodium ethanoate trihydrate. Content 99.0 per cent to 101.0 per cent (dried substance). CHARACTERS Appearance Colourless crystals. Solubility Very soluble in water, soluble in ethanol (96 per cent). IDENTIFICATION A. 1 ml of solution S (see Tests) gives reaction (b) of acetates (2.3.1). B. 1 ml of solution S gives reaction (a) of sodium (2.3.1). C. Loss on drying (see Tests). 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. ©Crown Copyright 2006 1 100 ml with the same solvent. Appearance of solution Solution S is clear (2.2.1) and colourless (2.2.2, Method II). pH (2.2.3) 7.5 to 9.0. Dilute 5 ml of solution S to 10 ml with carbon dioxide-free water R. Reducing substances Dissolve 5.0 g in 50 ml of water R, then add 5 ml of dilute sulphuric acid R and 0.5 ml of 0.002 M potassium permanganate . The pink colour persists for at least 1 h. Prepare a blank in the same manner but without the substance to be examined. Chlorides (2.4.4) Maximum 200 ppm. Dilute 2.5 ml of solution S to 15 ml with water R. Sulphates (2.4.13) Maximum 200 ppm. Dilute 7.5 ml of solution S to 15 ml with distilled water R. Aluminium (2.4.17) Maximum 0.2 ppm, if intended for use in the manufacture of dialysis solutions. Prescribed solutionDissolve 20 g in 100 ml of water R and adjust to pH 6.0 by the addition of 1 M hydrochloric acid (about 10 ml). Reference solutionMix 2 ml of aluminium stand