Abstract

The impurity content in active pharmaceutical ingredient (API) is of critical importance because a high level of impurities can be harmful to the patient, mainly due to their potential toxicity. The formation of these impurities is sometimes related to insufficient control of the reaction. Since there are several types of impurities, it is essential to understand their classification. The origin of these impurities involves different formation pathways, and by taking these pathways into account, it is possible to develop effective purification methods. Analytical methodologies are key tools for determining impurity structures and, consequently, for developing mitigation strategies. Impurities also have other uses, such as serving as standards in analytical methods and in establishing process limits. This article provides an overview of impurity management, including their origins within synthetic pathways, their classification, and potential purification approaches to ensure compliance with stringent quality standards for pharmaceutical substances and other uses of impurities

Keywords

pharmaceutical ingredients, impurities, classification, purification