Affiliation:
1. Analytical Research & Development MRL, Merck & Co., Inc. Rahway New Jersey USA
2. Process Enabling Technologies MRL, Merck & Co., Inc. Rahway New Jersey USA
3. Analytical Research & Development MRL, Merck & Co., Inc. Massachusetts, Boston USA
Abstract
Pharmaceutical development currently relies on quality separation methods from early discovery through to line‐of‐site manufacturing. There have been significant advancements made regarding the column particle packing, internal diameter, length connectivity, the understanding of the impact key parameters like void volume, flow rate, and temperature all that affects the resultant separation quality, that is, resolution, peak shape, peak width, run time, and signal‐to‐noise ratio. There is however a strong need to establish better alternatives to large bulky high‐performance liquid chromatography racks either for process analytical reaction monitoring or mass spectrometry analysis in establishing product quality. Compact, portable high‐pressure liquid chromatography can be a more efficient alternative to traditional ultra‐high pressure liquid chromatography and traditional liquid chromatography. The compact versatile instrument evaluated here allows good separation control with either the on‐board column with fixed ultra‐violet wavelength cartridge or for use with a high‐resolution mass spectrometry. Significant space reduction results in greener lab spaces with improved energy efficiency for smaller labs with lower energy demands. In addition, this compact liquid chromatography was used as a portable reaction monitoring solution to compare forced degradation kinetics and assess portable liquid chromatography‐mass spectrometry capability for the analyses required for pharmaceutical drug product testing.
Subject
Filtration and Separation,Analytical Chemistry