1. INTRODUCTION

Mass spectrometry (MS) is an integral part of modern pharmaceutical research and development in academic, industrial, and clinical laboratories. Trace analytical measurement (both qualitative and quantitative), specifically the demand for trace-mixture analysis, has increased the need for this powerful tool. In many cases, the analytical demands of trace-mixture sample analysis has made MS the method of choice for qualitative and quantitative assays for target analytes such as proteins, peptides, drug substances, metabolites, impurities, and degradation products. Because of its analytical capabilities, MS has found widespread application in the pharmaceutical industry. Specifically within the compendial context, MS has been, or has the potential to be, applied to both qualitative (identification tests) and quantitative measurements (assays).