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- 2019-12-23 发布于湖北
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阿司匹林及阿司匹林肠溶片的质量分析 知识点: 药品检验技术专业英语 课程:药品检验技术 The Analysis of Aspirin and Aspirin Enteric-coated Tablets Purpose 1. To learn about the procedures and the items for drug analysis. 2. To exercise on the analysis of Aspirin and its Enteric-coated Tablets. Procedures and methods Aspirin ( C9H8O4,FW=180.16,[ 50-78-2 ] ) Aspirin is 2 - ( acetyloxy ) – benzoic acid. It contains not less than 99.5% of C9H8O4 . 1.Description White crystals or a white crystalline powder; odourless or with a faint acetic acid odour; taste, faintly sour; gradually hydrolyses in contact with moisture to form salicylic acid and acetic acid; aqueous solution yields an acidic reaction. Freely soluble in ethanol; soluble in chloroform or ether; slightly soluble in water or anhydrous ether; soluble in solutions of sodium hydroxide or sodium carbonate with decomposition. 2.Identification (1) To about 0.1 g add 10 ml of water, boil and cool. Add 1 drop of ferric chloride TS; a violet colour is produced. (2) To about 0.5 g add 10 ml of sodium carbonate TS, boil for 2 minutes and cool. Add dilute sulfuric acid in excess; a white precipitate is produced and an odour of acetic acid is perceptible. (3) The infrared absorption spectrum ( Appendix Ⅳ C ) is concordant with the reference spectrum of aspirin ( Appendix ⅩⅥ ). 3.Clarity of solution A solution of 0.50 g in 10 ml of sodium carbonate TS preheated to about 45℃ is clear. Salicylic acid Dissolve 0.10 g in 1 ml of ethanol, add cold water to produce 50ml, add immediately 1 ml of freshly prepared dilute ferric ammonium sulfate solution [ to 1 ml of hydrochloric acid solution ( 9→100 ) add 2 ml of ferric ammonium sulfate IS and add water to produce 100 ml ] add mix well; any colour produced in 30 seconds is not more intense than that of a reference preparation ( dissolve 0.1 g of salicylic acid, accurately weighed, in water, add 1 ml of glacial acetic acid, mix well, add water
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