Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials

MA Yu-cui; WU Cui; WANG Wei; WANG Chun; DU Ning; WU Xiao-yi; LI Chun; CHAO Zhi-mao

doi:10.13422/j.cnki.syfjx.2017200051

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Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials

更新时间：2024-01-04

- Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 23, Issue 20, Pages: 51-55(2017)
- 作者机构：
- 作者简介：
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- DOI：10.13422/j.cnki.syfjx.2017200051
  CLC： R284.1
- Published：2017
- 稿件说明：
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MA Yu-cui, WU Cui, WANG Wei, et al. Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(20): 51-55.
DOI：

MA Yu-cui, WU Cui, WANG Wei, et al. Comparison of Long-term Stability and Acceleration Stability of Certified Reference Materials[J]. Chinese journal of experimental traditional medical formulae, 2017, 23(20): 51-55. DOI： 10.13422/j.cnki.syfjx.2017200051.

摘要

目的：探索天然产物标准样品的长期稳定性和加速稳定性之间的关系，为标准样品的有效期确定提供必要的技术支撑。方法：在研制5个国家标准样品（肉桂醛、樱花素、长梗冬青苷、水苏糖和β-谷甾醇）的过程中，将置于0~8℃条件下的样品，分别于第0，1，2，3，6，9，12，18，24个月测定各标准样品的纯度，进行长期稳定性检验。将置于温度（40±2）℃和相对湿度（75±5）%条件下的样品，分别于第0，1，2，3，6个月时测定各标准样品的纯度，进行加速稳定性检验。结果：统计分析的结果显示，长期稳定性检验和加速稳定性检验的稳定性均良好，二者之间无显著性差异。结论：天然产物标准样品24个月的有效期可通过6个月的加速稳定性检验进行预判。

Abstract

Objective: To explore the relationship between long-term stability and accelerated stability of certified reference materials (CRMs) of natural products

in order to provide technical support for the prediction of validity of CRMs. Method: In the process of development of 5 CRMs(cinnamaldehyde

sakuranetin

pedunculoside

stachyose and β-sitosterol)

the long-term stability test was carried out by determining their purities at 0

24 months under the temperature of 0-8℃ and the accelerated stability test was carried out by determining their purities at 0

6 months under temperature of (40±2)℃ and relative humidity of (75±5)%. Result: The results of statistical analysis showed that both long-term stability and accelerated stability were excellent and there were no significant difference between long-term stability and accelerated stability. Conclusion: The validity of 24 months of CRMs can be predicted on the bases of the result of accelerated stability test in 6 months.

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