美国药典-阿司匹林-中英对照

Aspirin(USP 34)
Aspirin contains not less than 99.5 percent and not more than 100.5 percent of
C9H8O4.calculated on the dried basis.
根据干燥品计算，本品C9H8O4为标示量的99.5%~100.5%。

Packaging and storage -Preserve in the tight containers.
包装与贮藏-贮藏于封闭的容器中。

USP REFERENCE STANDRANDS<11>-USP Aspirin RS
USP 标准物质-USP 阿司匹林对照品
Identification-
A: Heat it with water for minutes,cool,and add 1 or 2 drops ferric chloride TS: a violed-red color is produced.
鉴别-
1.水浴加热数分钟，冷却，加入1到2滴FeCl3 试液，测得颜色为紫红色。

B: Infrared Absorption
Loss on Drying-Dry it over silica gel for 5 hours: it loses not more than 0.5% of its weight.
干燥失重-硅胶干燥器中干燥5小时，减少重量不得超过0.5%。

Readily carbonizable substances-Dissolve 500mg in 5ml of sulfuric acid: the solution has no more color than matching fluid Q.
易碳化物-取500mg本品溶于5ml硫酸溶液中，溶液颜色不得深于标准溶液Q。

Residue on Ignition: not more than 0.05%.
炙灼残渣-不得超过0.05%。

Substances Insoluble in Sodium Carbonate TS-A solution of 500mg in 10ml of warm sodium carbonate TS is clear.
碳酸钠中不容物-取500mg本品溶于10ml温的碳酸钠溶液中，溶液因澄清。

Chloride-Boil 1.5g with 75ml of water for 5 minutes,cool,add sufficient water to restore the original volume, and filter（过滤）.A 25ml portion of the filtrate shows no more chloride than corredponds to(相当于) 0.10ml of 0.020N hydrochloride acid(0.014%)
氯化物-取本品1.5g，溶于75ml水中，煮沸5分钟，冷却，加入足量水至原体积，过滤。

取滤液25ml所含氯化物不得超过0.1ml 的0.02mol/L盐酸溶液中的氯化物（0.014%）。

Sulfate-Dissolve 6.0g in 37ml of acetone(丙酮),and add 3ml of water.Titrate （滴定）potentiometrically with 0.02M lead（铅）perchlorate（高氯酸盐）,prepared by dissolving 9.20g of lead perchlorate in water to make 1000ml of solution, using a pH meter capable of a minimum reproducibility of +-0.1mV (see pH<791>)and equipped with an electrode system consisting of a lead-specific electrode and a silver-silver chloride reference glass-sleeved electrode containing a solution of tetraethylammonium perchlorate in glacial acetic acid(1 in 44)(see titrimetry
<541>):not more than 1.25mL of 1.02M lead perchlorade is consumed (0.04%).[Note-After use, rinse（用水冲洗）the lead-specific electrode with water,drain the reference electrode,flush with water,rinse with methanol, and allow to dry（放干）.]
硫酸盐-取6.0g本品溶于37mL丙酮溶液中，加入水3mL。

用0.02mol/L的高氯酸铅溶液进行点位滴定。

取9.20g高氯酸铅溶于水中制成1000mL溶液，用最低再现性为+-0.1mL的pH 计进行测定，（参见PH法《791》），该pH计由一个铅电极和Ag-AgCl玻璃套管对照电极组成的电极系统。

用冰醋酸溶液溶解四乙胺高氯酸（1：44）（见滴定法541）作为缓冲液消耗的1.02mol/L的高氯酸铅不得超过1.25mL（0.04%）[注意：使用后，用水冲洗铅电极，将对照电极擦干，先用大量水冲洗，在用甲醇冲洗，放干]。

Heavy metals-Dissolve 2g in 25mL of acetone（丙酮）,and add 1mL of water.Add 1.2mL of thioacetamide-glycerin base TS and 2mL of pH 3.5 Acetate Buffer （缓冲液）(see Heavy Metals<231>),and allow to stand for 5 minutes:any color produced is not darker than that of a control made with 25mL of acetone and 2mL of Standard Lead solution(see heavy
metals<231>),treaded in the same manner.The limit is 10ug per g.
重金属-取2克本品溶于25mL丙酮，加1mL水。

加入1.2ml硫代乙酰胺-甘油试液和2mlph 值为3.5的醋酸缓冲液，（参阅重金属231）放置5分钟：颜色不得深于25ml丙酮和2ml标准铅溶液用同样方法处理所得的溶液。

限度是10ug/g.
Limit of Free Salicylic Acid-Dissolve 2.5g in sufficient alcohol to make 25ml.To each of two matched color -comparison tubes(比色管) add 48ml of water and 1ml of freshly prepared,diluted ferric ammonium sulfate solution (prepared by adding 1ml of 1N hydrochloric acid to 2ml of ferric ammonium sulfate TS and diluting with water to 100ml).Into one tubes pipet 1ml of a standard solution of salicylic acid in water,containing 0.10mg of salicylic acid per ml. Into the second tube pipet 1ml of the 1 in 10 solution of Aspirin . Mix the contents of each tube:after 30 seconds, the color in the second tube is not more intense than that in the tube containing the salicylic acid(0.10%).
游离水杨酸-取2.5g本品加入足够量乙醇至25ml。

两个比色管中各加入48ml的水和1ml 的新鲜配制的硫酸铁铵稀释液。

（配置方法：加入1mol/l的盐酸1ml于2ml的硫酸铁铵试液，加水稀释至100ml）第一管中加入1ml水杨酸标准溶液，加水使水杨酸的含量为0.10mg/ml 第二管中加入1ml(1/10)的阿司匹林溶液。

混合均匀：30秒后，第二管的颜色不得深于含有水杨酸溶液的管。

（0.1%）
Assay-Place about 1.5g of Aspirin, accurately weighed, in a flask, add 50.0ml of 0.5N sodium hydroxide VS,and boil the mixture gently（缓慢的）for 10 minutes.Add phenolphthalein TS,Add phenolphthalein TS, and titrate(滴定) the excess（过量）sodium hydroxide with 0.5N sulfuric acid VS.Perform a blank determination（准备空白对照）.Each ml of 0.5N sodium hydroxide is equivalent to 45.04mg of C9H8O4
含量测定-取1.5g阿司匹林于试管中，精密称定，加入0.5mol/l的氢氧化钠滴定液50.0ml，沸水中缓慢加热10分钟，加入酚酞试液，用0.5mol/l的硫酸滴定液滴定过量的氢氧化钠，准备一个空白对照，没1ml 0.5mol/l的氢氧化钠相当于45.04mg的C9H8O4.。