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Sulfamethoxazole（磺胺甲噁唑）

C10H11N3O3S 253.28 [723-46-6]

Sulfamethoxazole is 4-Amino-N-（5-methyl-3-isoxazolyl）benzenesulfonamide.

本品为N-（5-甲基-3-异噁唑基）-4-氨基苯磺酰胺。

It contains not less than 99.0% of C10H11N3O3S , calculated on the dried basis.

按干燥品计算，含C10H11N3O3S不得少于99.0%。

Description A white crystalline powder；odourless.

Practically insoluble in water；freely soluble in dilute hydrochloric acid；in sodium hydroxide TS and ammonia TS.

【性状】 本品为白色结晶性粉末；无臭。

本品在水中几乎不溶；在稀盐酸、氢氧化钠试液或氨试液中易溶。

Melting range 168–172℃（0612）

熔点 本品的熔点（通则0612）为168～172℃。

Identification （1）To about 0.1 g add 3 ml each of water and 0.4% sodium hydroxide solution，shake to dissove and filter.To the filtrate add 1 drop of copper sulfate TS；a yellowish-green precipitate is formed（distinction from Sulfafurazole）

【鉴别】（1）取本品约0.1g，加水与0.4％氢氧化钠溶液各3ml，振摇使溶解，滤过，取滤液，加硫酸铜试液1滴，即生成草绿色沉淀（与磺胺异噁唑的区别）。

（2）The infrared absorption spectrum（0402）is concordant with the reference spectrum（IR Album No.565）.

（2）本品的红外光吸收图谱（通则0402）应与对照的图谱（光谱集565图）一致。

（3）Yields the reaction characteristic of primary aromatic amines（0301）.

（3）本品显芳香第一胺类的鉴别反应（通则0301）。

Acidity To 1.0 g add 10 ml of water and shake well, pH4.0-6.0（0631）

酸度 取本品1.0g，加水10ml，摇匀，依法测定（通则0631），pH值应为4.0～6.0。

Clarity and colour of alkaline solution To 1.0 g add 5 ml of sodium hydroxide TS and 20 ml of water to dissove，the resulting solution is clear and colourless. Any opalescence produced is not more

pronounced than that of reference susupension 1（0902 method 1）；Any colour produced is not more intense than that of the reference solution（dilute 12.5ml of reference solution Y3 with water to 25ml）

（0901 method 1）

碱性溶液的澄清度与颜色 取本品1.0g，加氢氧化钠试液5ml与水20ml溶解后，溶液应澄清无色。如显浑浊，与1号浊度标准液（通则0902第一法）比较，不得更浓；如显色，与同体积的对照液（取黄色3号标准比色液12.5ml，加水至25ml）比较（通则0901第一法），不得更深。

Chlorides To 2.0g add 100 ml of water, shake and filter. Carry out the limit test for chlorides（0801）, using 25 ml of the filtrate. Any opalescence produced is not more pronounced than that of the reference prepared by using 5.0 ml of sodium chloride standard solution（0.01％）.

氯化物 取本品2.0g，加水100ml，振摇，滤过；分取滤液25ml，依法检查（通则0801），与标准氯化钠溶液5.0ml制成的对照液比较，不得更浓（0.01％）。

Sulfates Carry out the limit test for Sulfates（0802）,using 25 ml of the remaining filtrate. Any opalescence produced is not more pronounced than that of the reference solution prepared by using 1.0 ml of potassium sulfate standard solution（0.02％）.

硫酸盐 取氯化物项下剩余的滤液25ml，依法检查（通则0802），与标准硫酸钾溶液1.0ml制成的对照液比较，不得更浓（0.02％）。

Related substances Dissolve a quantity of the substance being examined in a mixture of ethanol and concentrated ammonia solution（9：1）, and produce a solution containing about 10 mg per ml as the test solution. Dilute an accurately measured volume of the test solution with the same mixture solvent to produce a solution containing about 50 μg per ml,and use as the reference solution. Carry out the method for thin-layer chromatography

（0502）,using silica gel H （containing 0.1% sodium carboxymethylcellulose as the binder）as the coating substance and a mixture of chloroform-methanol-dimethylfromamide（20：2：1）as the mobile phase. Apply separately to the plate 10μl of each of the above two resulting solutions. After development, remove the plate, dry it and spray with

ethanolic p-dimethylaminobenzaldehyde TS.Any spot due to impurity in the chromatogram obtained with test solution is not more intense than the principal spot obtained with the reference solution.

有关物质 取本品，加乙醇-浓氨溶液（9：1）制成每1ml中约含10mg的溶液，作为供试品溶液；精密量取适量，用乙醇-浓氨溶液（9：1）稀释制成每1ml中约含50μg的溶液，作为对照溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各10μl，分别点于同一以0.1％羧甲基纤维素钠为黏合剂的硅胶H薄层板上，以三氯甲烷-甲醇-N，N-二甲基甲酰胺（20：2：1）为展开剂，展开，晾干，喷以乙醇制对二甲氨基苯甲醛试液使显色。供试品溶液如显杂质斑点，与对照溶液的主斑点比较，不得更深。

Loss on drying When dried to constant weight at 105℃, loses not more than 0.5% of its weight

（0831）.

干燥失重 取本品，在105℃干燥至恒重，减失重量不得过0.5％（通则0831）。

Heavy metals Carry out the limit test for heavy metals （0821 method 3）,using the remaining solution obtained in the test for Clarity and colour of solution, not more than 0.0015%.

重金属 取碱性溶液的澄清度与颜色项下的溶液，依法检查（通则0821第三法），含重金属不得过百万分之十五。

Assay Dissolve 0.5 g, accurately weight, in 25 ml of hydrochloric acid solution（l→2）,add 25 ml of water,carry out the method for dead-stop titration（0701）,titrate with sodium nitrite（0.1mol/L）VS.Each ml of sodium nitrite（0.1mol/L）VS is equivalent to 25.33 mg of C10H11N3O3S.

【含量测定】 取本品约0.5g，精密称定，加盐酸溶液（l→2）25ml，再加水25ml，振摇使溶解，照永停滴定法（通则0701），用亚硝酸钠滴定液（0.1mol/L）滴定。每1ml亚硝酸钠滴定液（0.1mol/L）相当于25.33mg的C10H11N3O3S。

Category Suifonamide 【类别】 磺胺类抗菌药。

Storage Preserve in tightly closed containers,protected from light. 【贮藏】 遮光，密封保存。

Preparation

（1）Compound Sulfamethoxazole Capsules （2）Compound Sulfamethoxazole Granules （3）Compound Sulfamethoxazole Injection

（4）Compound Sulfamethoxazole Oral Suspension （5）Compound Sulfamethoxazole Tablets

（6）Pediatric Compound Sulfamethoxazole Granules （7）Pediatric Compound Sulfamethoxazole Tablets （8）Sulfamethoxazole Tablets

【制剂】（1）复方磺胺甲噁唑胶囊 （2）复方磺胺甲噁唑颗粒 （3）复方磺胺甲噁唑注射液 （4） 复方磺胺甲噁唑口服混悬液 （5）复方磺胺甲噁唑片（6）小儿复方磺胺甲噁唑颗粒（7）小儿复方磺胺甲噁唑片 （8）磺胺甲噁唑片