Measuring residual solvents in pharmaceutical samples using fast gas chromatography techniques.
Residual process solvents in pharmaceutical samples are monitored using gas chromatography (GC) with either flame ionization detection (FID) or mass spectrometry. Based on good manufacturing practices, measuring residual solvents is mandatory for the release testing of all active pharmaceutical ingredients and is routinely performed on samples of process intermediates. General GC methods have been developed to monitor solvents routinely used in the drug synthesis process. It is now possible to take advantage of GC equipment with faster temperature ramping capabilities, in combination with shorter capillary GC columns, to achieve a considerable gain in efficiency and a reduction in analysis turnaround time. In this paper, the development and implementation of fast GC methods for residual solvents testing will be discussed. Continued efforts to improve the efficiency of gas chromatography using existing technologies such as, the ThermoOrion Flash GC will also be discussed.
Rocheleau
Marie-Josée
MJ
Pharmaceutical Research Institute, Bristol-Myers Squibb, 100 Boulevard de l'Industrie, Candiac, Qué., Canada J5R 1J1. marie.rocheleau@bms.com
Titley
Mélanie
M
Bolduc
Julie
J
D002849:Chromatography, Gas / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012680:Sensitivity and Specificity; D012997:Solvents / Q000032:analysis*
D004364:Pharmaceutical Preparations; D012997:Solvents