A New Approach to Comparison of Original Pharmaceuticals and Generics Based on Comparison of Multidimensional Impurity Profiles Using Supercritical Fluid Extraction, Liquid Extraction, and GC-MS

摘要

This paper reports on our effort to study the possibility of comparing the original pharmaceuticals and their analogs (generics) based on comparisons of the multidimensional profiles of impurities isolated from samples by supercritical fluid extraction and liquid extraction and recorded by gas chromato-mass spec-trometry (GC-MS) with electron ionization (EI) and atmospheric pressure photochemical ionization (APPhCI). Using the suggested approach makes it possible to increase the number of recorded impurities, to show that the pharmaceutical samples are authentic, and to compare the original pharmaceuticals and gener-ics according to their quality.