美洛西林标准物质短期稳定性研究

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 study the effect of specified transport conditions on the properties of mezlocillin chemical reference substance. Methods: The short-term stability study was carried out at different temperatures and terms.Chromatographic peak area of mezlocillin was determined using the method described in Chinese Pharmacopoeia 2010 edition.The measurement results were assessed by SPSS Statistics 17.0 software according to the basic requirements of ISO Guide 35:2006. Results: The mezlocillin chemical reference substance in short-term position under dark conditions below 25 ℃ was stable. Conclusion: Transport conditions of mezlocillin chemical reference substance should ideally be chosen to make sure that the properties of reference material do not change during transport.In addition,the short-term stability study suggested an important guiding significance for the stability monitoring,and meanwhile provided a new approach to the stable monitoring of drug reference material.

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