Reactive impurities in excipients can cause drug product degradation or protein modification even at trace levels, and thus impact drug stability and quality. It is critical to understand the potential impact of these impurities during development in order to ensure a robust clinical and commercial product. In this article, we review reactive impurities in pharmaceutical and biopharmaceutical excipients for both small molecule and large molecule drugs. The common reactive impurities in excipients, including peroxides, aldehydes, organic acids, reducing sugars and elemental impurities are reviewed. Sources of these impurities, reactions and impact, analytical methods, and control and risk mitigation strategies are also discussed.

赋形剂中的反应性杂质甚至会导致痕量水平的药物降解或蛋白质修饰，从而影响药物的稳定性和质量。至关重要的是要了解这些杂质在开发过程中的潜在影响，以确保获得可靠的临床和商业产品。在本文中，我们回顾了小分子和大分子药物在药物和生物制药赋形剂中的反应性杂质。综述了赋形剂中常见的反应性杂质，包括过氧化物，醛，有机酸，还原糖和元素杂质。还讨论了这些杂质的来源，反应和影响，分析方法以及控制和缓解风险的策略。