USP葡萄糖译文.doc

Dextrose 葡萄糖C6H12O6H2O 198.17D-Glucose, monohydrate. D-Glucose monohydrate 5996-10-1.Anhydrous 180.16 50-99-7.C6H12O6H2O 分子量：198.17C6H12O6 分子量：180.16 Dextrose is a sugar usually obtained by the hydrolysis of starch. It contains one molecule of water of hydration or is anhydrous.葡萄糖是淀粉水解而得到的一种糖，常以一水葡萄糖或无水葡萄糖的形式存在。Packaging and storage Preserve in well-closed containers. 包装与贮存：本品保存在密闭容器中。Labeling Label it to indicate whether it is hydrous or anhydrous. 注释：注明其为无水状态或水合物状态。Identification Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS: a copious red precipitate of cuprous oxide is formed. 鉴别：加本品溶液（1比20）数滴于5mL热的碱性酒石酸铜试剂中，会形成大量红色的氧化亚铜沉淀。Color of solution Dissolve 25 g in water to make 50.0 mL of solution: the solution has no more color than a solution prepared by mixing 1.0 mL of cobaltous chloride CS, 3.0 mL of ferric chloride CS, and 2.0 mL of cupric sulfate CS with water to make 10 mL, and diluting 3 mL of this solution with water to 50 mL. Make the comparison by viewing the solutions downward in matched color-comparison tubes against a white surface. 溶液颜色：取本品25g，用水溶解配制成50mL的溶液，该溶液颜色不得深于对照液颜色（将1.0mL氯化钴溶液、3.0mL氯化铁溶液和2.0mL硫酸铜溶液混匀后用水配制成10mL，取3mL该溶液用水稀释至50mL即得到对照液）。通过在白色背景下观察溶液下流至相应比色管来进行颜色对比分析。Specific rotation 781S: between +52.6 and +53.2. Test solution: 100 mg per mL, in 0.012 N ammonium hydroxide. 比旋度：应在+52.6and +53.2之间，用100mg/mL的本品溶液与0.012 N的氨试液反应测定。Acidity Dissolve 5.0 g in 50 mL of carbon dioxide-free water. Add phenolphthalein TS, and titrate with 0.020 N sodium hydroxide to the production of a distinct pink color: not more than 0.30 mL is required for neutralization. 酸度：取本品5.0g，用不含CO2的水溶解稀释至50mL，滴加酚酞作为指示剂，用0.020N的氢氧化钠溶液滴定至出现明显粉红色：中和反应要求滴定量不应多余0.30mL。Water, Method III 921 Dry it at 105 for 16 hours: the hydrous form loses between 7.5% and 9.5% of its weight, and the anhydrous form loses not more than 0.5% of its weight. 水分：将本品在105条件下烘干16小时，要求水分损失率应在7.5% 至9.5%之间，非水分损耗率不得高于0.5%。Residue on ignition 281: not more than 0.1%. 灰分：不得高于0.1%。Chloride 221 A 2.0-g portion shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid (0.018%). 氯化物：2.0 g本品中氯化物含量不得高于0.50 mL 的0.020 N 盐酸（0.018%）的氯化物含量。Sulfate 221 A 2.0-g portion shows no more sulfate than corresponds to 0.50 mL of 0.020 N sulfuric acid (0.025%). 硫酸盐：2.0 g本品中硫酸盐含量不得高于0.50 mL 的0.020 N 硫酸（0.025%）的硫酸盐含量。Arsenic, Method I 211: 1 ppm. 砷含量：不大于1 ppm。参照方法1Heavy metals 231 Dissolve 4.0 g in water to make 25 mL of solution: the limit is 5 ppm. 重金属含量：取本品4.0 g用水溶解配制成25 mL的溶液，重金属含量的上限是5 ppm。参照重金属检查Dextrin Reflux 1 g of finely powdered Dextrose with 20 mL of alcohol: it dissolves completely. 葡聚糖：用20 mL乙醇回流1 g本品粉末，应完全溶解。Soluble starch, sulfites To a solution of 1 g in 10 mL of water add 1 drop of iodine TS: the liquid is colored yellow. 可溶性淀粉和亚硫酸盐：在本品溶液（取1 g本品溶解于10 mL水）中加一滴碘液，溶液应为黄色。Auxiliary Information Please check for your question in the FAQs before contacting USP. Topic/QuestionContactExpert CommitteeMonographDaniel K. Bempong, Ph.D. Senior Scientist1-301-816-8143(MDPS05) Monograph Development-Pulmonary and SteroidsUSP32NF27 Page 2107P