Jian Ning
Senior Scientist, Chemical Process Technologies Analytical Research, Schering Plough Research Institute

"A case study: On-line Micro HPLC Real Time Reaction Monitoring Process Analytics Technology"

Bio:

Jian Ning is a Senior Scientist at Schering-Plough Research Institute in Chemical Process Technologies Analytical Research department.  He received is Masters of Science of Engineering in Chemical Engineering from NJIT and his MBA from Fairleigh Dickinson University.  He has over 16 years experience in chromatographic method development, special interests including chiral separation and PAT application in chemical processes of earlier phase drug development.

Abstract:

A heterogeneous reaction mixture was monitored real time with an On-line micro HPLC in the process development lab. A rapid gradient method was developed using a Waters Xterra C18 (10cm x 0.3mm, 3µm) column with a basic mobile phase. The analysis time is 6.8 min, including equilibrium. Multiple reaction samples (28µl) were withdrawn and filtered from the reaction flask, quenched, diluted, injected into HPLC and analyzed with full automation during the eight hour reaction. The real time kinetic data of peaks of interest are simultaneously plotted during the reaction. Chromatograms obtained are stacked for comparison. The data generated provides sufficient information on conversion rate as well as impurity generation for process optimization. The micro scale of the HPLC allows a significant reduction in both solvent and waste, about 0.4% of a regular HPLC analysis, so this is a green chemistry PAT.