阿莫西林中高分子杂质的测定与质量分析
Studies on the separation and quality of high molecular weight impurities in amoxicillin
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摘要: 目的比较不同厂家阿莫西林原料、胶囊、混悬剂中高分子杂质的含量。方法采用OhpakSB-802.5HQ(聚合基柱)高效液相凝胶色谱系统进行分离分析。结果21批阿莫西林样品中高分子杂质的测定结果均为1%以下。结论国产与进口阿莫西林中的高分子杂质含量无显著差异。Abstract: OBJECTIVE To develop a method for determination the high molecular impurities in amoxicillin to evaluate the quality of amoxicillin and its capsule or suspension.METHODS Determination of high molecular impurities using Ohpak SB-802.5HQ gel filtration chro
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