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Ascorbic Acid Injection Assay— Mobile phase— Dissolve 15.6g of dibasic sodium phosphate and 12.2g of monobasic potassium phosphate in 2000mLof water,adjust with phosphoric acid to a pHof 2.5±0.05.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ  . Standard preparation— Dissolve an accurately weighed quantity of USP Ascorbic Acid RSin Mobile phase,and mix to obtain a solution having a known concentration of about 0.5mg per mL.[NOTE—Refrigerate and store protected from light until use.The solution is stable for at least 24hours.Inject within 3hours after removal from the refrigerator.] Assay preparation— Dilute the Injection,quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a concentration of about 0.5mg per mL.[NOTE—Refrigerate and store protected from light until use.The solution is stable for at least 24hours.Inject within 3hours after removal from the refrigerator.] Chromatographic system (see Chromatography á621ñ —The liquid chromatograph is equipped with a 245-nm detector and a 6-mm ×150-mm column that contains packing L39.The flow rate is about 0.6mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the column efficiency is not less than 3500theoretical plates,the tailing factor is not more than 1.6,and the relative standard deviation for replicate injections is not more than 1.5%. Procedure— Separately inject equal volumes (about 4µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peak.Calculate the quantity,in mg,of ascorbic acid (C6H8O6)in each mLof the Injection taken by the formula: CD(rU/rS), |
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251433054(金币+1,VIP+0):谢谢 但是我需要的吧是这个地方的翻译 3-29 16:21
251433054(金币+1,VIP+0):谢谢 但是我需要的吧是这个地方的翻译 3-29 16:21
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Make adjustments if necessary (see System Suitability under Chromatography) 如果有必要作出调整（见色谱下的系统适用性)。 Separately inject equal volumes (about 4µL)of the Standard preparation and the Assay preparationinto the chromatograph 分别进样等量体积的（大约4μl ）的标准品和试验品入色谱中。 |
3楼2009-03-29 16:08:56
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木虫 (小有名气)
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251433054(金币+5,VIP+0):谢谢应助，但是好像不太完整 有高人能弥补下不，照给金币 3-29 15:46
251433054(金币+4,VIP+0):已翻译完毕 3-30 11:23
251433054(金币+5,VIP+0):谢谢应助，但是好像不太完整 有高人能弥补下不，照给金币 3-29 15:46
251433054(金币+4,VIP+0):已翻译完毕 3-30 11:23
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维生素C注射液含量测定 流动相：15.6g磷酸氢二钠和12.2g磷酸二氢钾溶于2000ml水中，用磷酸调PH值至2.5±0.05. 标准品制备：精密称定维生素C对照品，溶解并定量稀释成0.5mg/ml。（注意-使用前应冷藏并避光保存。溶液在24h内稳定。在拿出冰箱3小时内进样。） 样品制备：用流动相逐步稀释注射液到0.5mg/ml.( 注意-使用前应冷藏并避光保存。溶液在24h内稳定。在拿出冰箱3小时内进样。) 色谱条件——检测波长245nm，6mm*150mm填充柱。流速0.6ml/min，理论塔板数不低于3500.拖尾因子不得大于1.6，重复进样的标准差不得大于1.5%。 检测过程——分别进样，0.4μl。计录色谱图，和最大吸收峰。计算每ml注射液含维C的mg数。 |
2楼2009-03-29 15:44:06