Identification of an Impurity in a New Formulation of Isoproterenol Hydrochloride Injection Using High Resolution Mass Spectrometry, Tandem Mass Spectrometry, and UV/Vis Spectroscopy

摘要

Elucidation of the structure of pharmaceutical impurities and degradation products is an important part of the drug development process. These impurities and degradation products can have unwanted toxicological or pharmacological effects that can have a serious impact for both patient safety and product quality. Utilizing tandem (or multiple stage) mass spectrometry and high resolution (accurate mass) mass spectrometry have proven useful in deriving the identities of pharmaceutical degradation compounds [1-3]. Comparative analysis of an impurity or degradation product's molecular signature (such as a UV spectrum) with compounds containing similar structural components can provide additional support of structural confirmation.