...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Bioanalysis >Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis
【24h】

Evaluation of stability using one versus three tubes for each quality control concentration in matrix-based bioanalysis

机译：基于基于基于基于基质生物分析的每个质量控制浓度，使用一种与三管的稳定性评估

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Aim: Contract research organizations and pharmaceutical firms have performed stability testing using one of two methods: storing in the freezer a single tube of matrix for each quality control concentration (Method 1), followed by aliquoting and analysis; and storing three tubes for each quality control concentration, followed by analysis (Method 2). This research project was conducted to determine if there were detectable differences between Method 1 and Method 2. Methodology: Five model drugs were selected: teriflunomide (stable compound) and acetyl salicylic acid, simvastatin, tenofovir alafenamide and valganciclovir (stability concerns). Samples were stored at -80 degrees C for 1, 3 and 12 months and then analyzed. Samples were also placed at different locations within the freezer. Results: For the drugs tested, the results suggest that there is no significant difference in the outcome of stability testing, regardless whether Method 1 or Method 2 was followed.
机译：目的：合同研究组织和制药公司使用两种方法之一进行了稳定性测试：在冰箱中存放在冰箱中，用于每个质量控制浓度（方法1），然后等分分析; 并将三个管用于每个质量控制浓度，然后进行分析（方法2）。 进行该研究项目以确定方法1和方法2之间是否存在可检测的差异 将样品在-80℃下储存1,3和12个月，然后分析。 样品也被置于冰箱内的不同位置。 结果：对于测试的药物，结果表明，无论是否遵循方法1或方法2，稳定性测试结果都没有显着差异。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号