Supercritical fluid chromatography for GMP analysis in support of pharmaceutical development and manufacturing activities
详细信息 查看全文
- 作者：Michael B. Hicks ; michael.hicks@merck.com" class="auth_mail" title="E-mail the corresponding author ; Erik L. Regalado ; Feng Tan ; Xiaoyi Gong ; Christopher J. Welch
- 关键词：Supercritical fluid chromatography ; GMP SFC ; Enantiomers ; Pharmaceutical impurities ; Chiral stationary phases ; Method validation
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2016
- 出版时间：5 January 2016
- 年：2016
- 卷：117
- 期：Complete
- 页码：316-324
- 全文大小：2515 K
文摘
- •
Current SFC instruments applied to the release of clinical material in good manufacturing labs.
- •
Sensitivity and injection reproducibility key improvements over past instruments.
- •
Improved sensitivity, high resolution and shorter run times expedite GMP analyses.
- •
Case studies show SFC implementation compared to currently available chiral HPLC.
- •
Robustness, inter-site precision and instrument qualification considerations given.