Min Li
Huahai Pharmaceutical Co. Ltd, China
Title: Application of LC-MSn molecular fingerprinting in the rapid elucidation of drug impurities
Biography
Biography: Min Li
Abstract
ICH guidelines require that impurities of drug substances and products be identified and/or qualified once they exceed certain thresholds. The identification of these impurities, including process impurities and degradation products, can be quite challenging and time-consuming. In this presentation, the use of LC-MSn molecular fingerprinting in conjunction with knowledge of process and/or drug degradation chemistry will be shown to be a very effective way in the rapid elucidation of unknown drug impurities. MSn fragmentation patterns (n is typically 2 to 3) generated with suitable collision energy are highly reproducible on same type of MS instrument and collectively, they provide a unique molecular fingerprint for a particular impurity. With the relevant process chemistry (for process impurities) or drug degradation chemistry (for degradation products) in mind, comparison of the MSn fingerprint of an unknown impurity with those of known compounds, especially the isomers of the unknown impurity, can quickly yield critical structural information, which will greatly expedite the process of structure elucidation. This approach will be demonstrated through several case studies involving structurally diverse drug