Abstract
Analytical methods are used in the biopharmaceutical industry to ensure the quality, efficacy, and safety of drug substances and drug products. One of the fundamental measures of the quality of a drug substance or drug product, including biopharmaceuticals, is the stability of the active pharmaceutical ingredient (API). In fact, the first International Council for Harmonization (ICH) guideline on quality, ICH Q1, is for drug stability. In this column, we look at drug stability in general, differences between large- and small-molecule stability (ICH Q1 and ICH Q5), as well as the analytical methods used to measure the stability of a product. Although there are several analytical methodologies that can be used, and we touch on those briefly, we focus mostly on the chromatography and mass spectrometry methods used to characterize drug stability.
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