Chiral supercritical fluid chromatography (SFC) has been the preferred method for chiral purity analysis in pharmaceutical research. Automated chiral SFC screening allows for quick chiral method development and fast enantiopurity analysis. However, SFC has historically been considered to be unsuitable for the accurate and precise measurements required for release testing of active pharmaceutical ingredients (APIs) under current Good Manufacturing Practices (cGMPs) conditions and regulations. Insufficient signal to noise ratio, as compared to HPLC, has heretofore been the major limitation of chiral SFC approach. In this presentation, we will describe various instrument modifications, including implementation of a new and improved detection flow cell, that allow suitable sensitivity and accuracy for carrying out enantiopurity analysis for GMP release testing of APIs using chiral SFC.
Back to Analytical Chemistry General Session I
Back to The Middle Atlantic Regional Meeting (May 16 - 18, 2007)