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从过氧化增研究中进行的稳定性评估.

Alexandra H Heussner1, Marlene Hermann1, Melanie Zerulla-Wernitz1

  • 1Analytical Science Laboratory, Development Service, Vetter Pharma-Fertigung GmbH & Co. KG, Schuetzenstrasse 87, 88212 Ravensburg, Germany.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
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PubMed
概括

检测药品中的过氧化 (H2O2) 残留物对于消毒至关重要. 稳定性研究表明,仅在-80°C的储存温度下,低度的H2O2可保持长达两个月.

关键词:
阿姆普勒克斯 超红色 超红色分析物的稳定性H ((2) O ((2)) 的情况.过氧化是一种过氧化.在VHP中使用VHP.如果是WIFI的话.

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科学领域:

  • 分析化学 分析化学
  • 制药科学 制药科学
  • 化学工程是化学工程的重要组成部分.

背景情况:

  • 确保隔离器和洁净室消毒的安全性取决于精确检测过氧化 (H2O2) 残留物.
  • 监测空气中的H2O2很简单,但在无菌填充的药品中检测微量H2O2会带来重大分析挑战.
  • 适当的样品处理,储存和运输在工业环境中至关重要,需要了解各种矩阵中分析物的稳定性.

研究的目的:

  • 为了评估低度过氧化 (H2O2) 在各种储存条件下的水溶液中的稳定性.
  • 在制药生产中遇到的相关矩阵中提供H2O2的基本稳定性数据.
  • 在分析前确定最佳储存温度,以保持样本中的H2O2完整性.

主要方法:

  • 过氧化 (H2O2) 在两种度下被入四种不同的水性矩阵 (水,缓冲剂,含/不含蛋白质的辅助剂溶液).
  • 样品在四种不同的温度 (-80°C,-20°C,4°C,25°C) 保存长达60天.
  • 使用定量,度的Amplex UltraRed测定方法来分析H2O2回收.

主要成果:

  • 在储存温度高于-80°C时,观察到H2O2的显著降解.
  • 只有在-80°C的储存条件下,H2O2度升的可接受回收率才被证明是可以接受的.
  • 在 -80°C储存时,H2O2的良好回收可维持长达两个月.

结论:

  • 在 -80°C的超低温储存对于在水性矩阵中保持低度的过氧化 (H2O2) 非常重要.
  • 标准的储存条件导致大量的H2O2损失,影响了残留分析的准确性.
  • 这些发现对于制药消毒过程中可靠的质量控制至关重要.