Tan Aimin, Wu Yanxin, Gu Guifen, Fanaras John C
Nucro-Technics, Scarborough, ON, Canada.
Nucro-Technics, Scarborough, ON, Canada.
J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Oct 15;1033-1034:112-116. doi: 10.1016/j.jchromb.2016.08.019. Epub 2016 Aug 12.
This paper presents the trouble-shooting for a very unusual stability case. Tetracaine was found unstable in neat solutions only at high concentrations, but not at low concentrations. Moreover, its stable-isotope labeled internal standard did not show similar behavior. A series of trouble-shooting experiments were conducted to uncover the root cause. Some generally applicable precautions/insights can be drawn from this investigation to avoid potential stability issues during bioanalytical method development and validation.
本文介绍了一个非常特殊的稳定性案例的故障排查情况。仅在高浓度时,丁卡因在纯溶液中被发现不稳定,而在低浓度时则不然。此外,其稳定同位素标记的内标并未表现出类似行为。进行了一系列故障排查实验以找出根本原因。从该调查中可以得出一些普遍适用的预防措施/见解,以避免在生物分析方法开发和验证过程中出现潜在的稳定性问题。