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本人急需英国药典BP98版，哪位高人，直接发我邮箱：genebest@126.com 万分感谢！ [ Last edited by genebest on 2009-8-14 at 14:42 ] |
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General Notices [bitmap] C4H6O6 150.1 87-69-4 Tartaric Acid complies with the requirements of the 4th edition of the European Pharmacopoeia [0460]. These requirements are reproduced after the heading `Definition' below. Ph Eur DEFINITION Tartaric acid contains not less than 99.5 per cent and not more than the equivalent of 101.0 per cent of (2R,3R)-2,3-dihydroxybutanedioic acid, calculated with reference to the dried substance. CHARACTERS A white or almost white, crystalline powder or colourless crystals, very soluble in water, freely soluble in alcohol. IDENTIFICATION A. Solution S (see Tests) is strongly acid (2.2.4). B. It gives the reactions of tartrates (2.3.1). TESTS Solution S. Dissolve 5.0 g in distilled water R and dilute to 50 ml with the same solvent. Appearance of solution. Solution S is clear (2.2.1) and not more intensely coloured than reference solution Y6 (2.2.2, Method II). Specific optical rotation (2.2.7). Dissolve 5.00 g in water R and dilute to 25.0 ml with the same solvent. The specific optical rotation is +12.0?to +12.8? Oxalic acid. Dissolve 0.80 g in 4 ml of water R. Add 3 ml of hydrochloric acid R and 1 g of zinc R in granules and boil for 1 min. Allow to stand for 2 min. Collect the liquid in a test-tube containing 0.25 ml of a 10 g/l solution of phenylhydrazine hydrochloride R and heat to boiling. Cool rapidly, transfer to a graduated cylinder and add an equal volume of hydrochloric acid R and 0.25 ml of a 50 g/l solution of potassium ferricyanide R. Shake and allow to stand for 30 min. Any pink colour in the solution is not more intense than that in a standard prepared at the same time in the same manner using 4 ml of a 0.1 g/l solution of oxalic acid R (350 ppm calculated as anhydrous oxalic acid). Chlorides (2.4.4). 5 ml of solution S diluted to 15 ml with water R complies with the limit test for chlorides (100 ppm). Sulphates (2.4.13). 10 ml of solution S diluted to 15 ml with distilled water R complies with the limit test for sulphates (150 ppm). Calcium (2.4.3). To 5 ml of solution S add 10 ml of a 50 g/l solution of sodium acetate R in distilled water R. The solution complies with the limit test for calcium (200 ppm). Heavy metals (2.4.8). 2.0 g complies with limit test C for heavy metals (10 ppm). Prepare the standard using 2 ml of lead standard solution (10 ppm Pb) R. Loss on drying (2.2.32). Not more than 0.2 per cent, determined on 1.000 g by drying in an oven at 100癈 to 105癈. Sulphated ash (2.4.14). Not more than 0.1 per cent, determined on 1.0 g. ASSAY Dissolve 0.650 g in 25 ml of water R. Titrate with 1M sodium hydroxide using 0.5 ml of phenolphthalein solution R as indicator, until a pink colour is obtained. 1 ml of 1M sodium hydroxide is equivalent to 75.05 mg of C4H6O6. |
3楼2009-08-17 11:41:32
