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目的:考察运输条件对于美洛西林标准物质特性量值有效性的影响情况。方法:根据药品标准物质在运输过程中可能发生的环境变化,选取温度及时间作为药品标准物质美洛西林对照品短期稳定性研究的变量,按中国药典2010年版HPLC分析方法进行测定,参照ISO Guide 35:2006的基本要求使用SPSS Statistics 17.0软件对结果进行评估。结果:美洛西林对照品在不超过25℃避光条件下短期放置稳定。结论:最终确定了适宜美洛西林对照品的运输条件,确保了其特性量值在运输过程中的有效性。此外,短期稳定性研究的评估结果也为该标准物质的稳定性监测工作提供了重要的指导意义,为药品标准物质稳定性监测提供了新的思路。
OBJECTIVE: To investigate the effect of transport conditions on the validity of the value of mezlocillin standard substance. Methods: According to the environmental changes that may occur during the transportation of drug standard substances, the temperature and time were selected as the variables for the short-term stability study of standard reference substance of mezlocillin according to the 2010 edition of the Chinese Pharmacopoeia. According to ISO Guide 35: 2006 BASIC REQUIREMENTS The results are evaluated using SPSS Statistics 17.0 software. Results: The reference standard for mezlocillin was stable for short periods at no more than 25 ° C in the dark. CONCLUSIONS: The shipping conditions for the appropriate mezlocillin reference substance were finally determined, ensuring the validity of their characteristic values during transport. In addition, the evaluation results of the short-term stability study also provide important guidance for the stability monitoring of the standard substance, and provide a new idea for the stability monitoring of the standard drug substance.