EP 8.0 各论：丙酮 01/2008:0872 (中英文）EP 7.001/2008:0872ACETONE丙酮C3H6O67-64-1 Mr 58.08【定义】Propanone丙酮。【CHARACTERS性状】Appearance: volatile, clear, colourless liquid外观：挥发性、澄清，无色液体。Solubility: miscible with water and with ethanol (96% per cent).溶解性：与水和乙醇（96%）互溶。The vapor is flammable.蒸气易燃。【IDENTIFICATION鉴别】A. Relative density (see Tests)A：比重（见检查项）。B.To 1mL, add 3mL of dilute sodium hydroxide solution R and 0.3mL of a 25g/L solution of sodium nitroprusside R. An intense red colur is produced which becomes violet with the addition of 3.5mL of acetic acid R.B：于1ml样品中，加3ml稀氢氧化钠溶液（R），0.3ml的25g/L硝普钠（亚硝酰铁氰化钠）（R）溶液。应呈深红色，加3.5ml醋酸（R）后变为紫色。稀氢氧化钠溶液配制方法：Sodium Hydroxide Solution, Dilute An 8.5% w/v solution of sodium hydroxide (about 2M ).硝普钠：Sodium Nitroprusside Sodium pentacyanonitrosylferrate(III) dihydrate; Na2Fe(CN)5(NO),2H2O = 298.0 (13755-38-9) Analytical reagent grade of commerce. Reddish brown powder or crystals）C. To 10mL of a 0.1 per cent V/V solution of the substance to be examined in ethanol (50 per cent V/V) R, add 1mL of a 10g/L solution of nitrobenzaldehyde R in ethanol (50 per cent V/V) R and 0.5mL of strong sodium hydroxide solution R. Allow to stand for about 2 min and acidify with acetic acid R. Agreenish-blue colour is produced.C：取10ml的0.1%（V/V）样品在乙醇中（50%V/V）（R）稀释液，加1ml的10mg/L对硝基苯甲醛（R）乙醇（50%V/V）溶液，加0.5ml浓氢氧化钠溶液（R）。放置约2分钟，用醋酸（R）酸化，应显蓝绿色。浓氢氧化钠溶液（R）：Sodium Hydroxide Solution, Strong A 42% w/v solution of sodium hydroxide (about 10M ).【TESTS检查】Appearance of solution. To 10mL add 10mL of water R. The solution is clear (2.2.1) and colourless (2.2.2, Method II).溶液外观：取10ml样品，加10ml水，溶液应澄清（附录2.2.1）无色（附录2.2.2，方法）。Acidity or alkalinity. To 5mL add 5mL of carbon dioxide-free water R, 0.15mL of phenolphthalein solution R and 0.5mL of 0.01M sodium hydroxide. The solution is pink. Add 0.7mL of 0.01M hydrochloric acid and 0.05mL of methyl red solution R. The solution is red or orange.酸碱度：取样品5ml，加5ml无二氧化碳的水（R），0.15mL酚酞试液（R）与0.5ml的0.01M氢氧化钠，溶液显粉色。加0.7ml的0.01M盐酸，0.05ml甲基红指示液（R），溶液显红色或橙色。酚酞试液：Phenolphthalein Solution Dissolve 0.1 g of phenolphthalein R in 80 ml of alcohol R and dilute to 100 ml with water R. Complies with the following test. Test for sensitivity To 0.1 ml of the phenolphthalein solution add 100 ml of carbon dioxide-free water R. The solution is colourless. Not more than 0.2 ml of 0.02 M sodium hydroxide is required to change the colour to pink. Colour changepH 8.2 (colourless) to pH 10.0 (red) 甲基红试液：Methyl Red Solution Dissolve 50 mg of methyl red in a mixture of 1.86 ml of 0.1M sodium hydroxide and 50 ml of ethanol (96%) and add sufficient water to produce 100 ml. Complies with the following test. Sensitivity A mixture of 0.1 ml of the solution, 100 ml of carbon dioxide-free water and 0.05 ml of 0.02M hydrochloric acid VS is red. Not more than 0.1 ml of 0.02M sodium hydroxide VS is required to change the colour of the solution to yellow. Colour changepH 4.4 (red) to pH 6.0 (yellow). Relative density (2.2.5): 0.790 to 0.793.比重（附录2.2.25）：0.7900.793Reducing substances. To 30mL add 0.1mL of 0.02M potassium permanganate and allow to stand in the dark for 2h. The mixture is not completely decolorized.还原性物质：取样品30ml，加0.1ml的0.02m高锰酸钾，在黑暗中放置2小时，混合物不得全褪色。Related substances. Gas chromatography (2.2.28).有关物质：气相（附录2.2.28）Test solution. The substance to be examined.供试液：待检样品Reference solution (a). To 0.5mL of methanol R add 0.5mL of 2-propanol R and dilute to 100.0mLwith the test solution. Dilute 1.0mL of this solution to 10.0mL with the test solution.对照液（a）：取0.5ml异丙醇（R）加于0.5ml甲醇（R）中，用供试液稀释至100.0ml。移取1.0ml用供试液稀释至10.0ml。Reference solution (b). Dilute 100uL of benzene R to 100.0mL with the test solution. Dilute 0.20mL of this solution to 100.0mL with the test solution.对照液（b）：取100L苯（R）于100.0mL容量瓶，用供试液稀释至刻度。移取0.20ml该溶液用供试液稀释至100.0ml。Column: 色谱柱：-material: fused silica,色谱柱材料：熔融石英-size: l=50m, D=0.3mm尺寸：l=50m，D=0.3mm-stationary phase: macrogol 20,000R (film thickness 1um).固定相：聚乙二醇20000R（膜厚 1m）Carrier gas: helium for chromatography R.载气：高纯氦气（Helium He = 4.003 (7440-59-7) Laboratory cylinder grade of commerce containing not less than 99.995% v/v of He）. Linear velocity: 21cm/s.线速度：21cm/sSplit ration:1:50分流比：1：50Temperature 升温程序Time 时间（min 分钟）Temperature 温度（）Column 柱温0-114510011-20100Injection port进样口150Detector 检测器250Detection: flame ionization.检测器：FID Injection: 1uL.进样量：1LRetention time: impurity C = about 7.5min保留时间：杂质C（苯）=约7.5分钟System suitability: 系统适用性：-resolution: minimum 5.0 between the peak due to impurity A (2nd peak) and the peak due to impurity B (3rd peak) in the chromatogram obtained with reference solution (a).分离度：对照液（a）中杂质A（第2个峰）与杂质B（第3个峰）分离度不小于5.0-signal-to-noise ration: minimum 5 for the peak due to impurity C in the chromatogram obtained with reference solutio