Challenges, Progress and Promises of Impurities Annotation for LCMSIT- TOF

Abstract

: Analysis of pharmaceutical products, as well as their active and inactive ingredients, and identification and characterization of potential impurities originating from raw materials and manufacturing processes is of importance in the field, especially for further assessment of potential positive or negative effects on the human body. In addition to expected therapeutic effects, unfortunately, some unwanted or adverse effects were encountered in the past, resulting in dramatic cases sometimes. These challenges have been overcome with the use of sophisticated and high-end analytical techniques today by focusing on developing more efficient, more accurate, more accessible, and faster determination techniques. : One of the powerful techniques utilized under the given aim, especially for qualitative purposes, is the Time of Flight (TOF) based Mass Spectrometry (MS). Among the TOF-MS instruments, liquid chromatography- mass spectrometry-ion trap-time of flight (LCMS-IT-TOF) has a unique MSn capability, which is a versatile tool in exact mass prediction and structure elucidation. In this review, LCMS-ITTOF has been considered taking all aspects to account for its use in qualitative impurity profiling, and a retrospective view on previous studies was presented in an analytical manner.