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硫酸阿米卡星注射液含量与有关物质的测定方法及处方工艺的优化

上传者:徐小白 |  格式:pdf  |  页数:95 |  大小:0KB

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provision. Conclusion:1 64%of thesamples’osmotic pressure were lower than thatofnormal human’S,it could cause hemolysis inlow permeability.The result of osmotic pressure suggested that the prescription of individual enterprise was not scientific.2 The investigation about pH value showed that the current standard forpH limit(4.0~7.O)was too broad.Then itdetermined that the pH limitf3.5~5.5)in USP35 and BP2012 was reasonable,which provided the basis for the revision ofthe standard andquality contr01.3 Through the investigation about Sterilization condition,we suggested that 7 万方数据英文摘要 enterprises adopted moist heatsterilization(1 21℃1 5min)in order to ensure aseptic level. Key words:Amikacin,the HPLC—UV end absorption method,HPLC— PED,osmotic pressure,pH value,sterilization conditions 8 万方数据

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