Drug impurity and degradation profiling mean the detection, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. This is today one of the most important fields of activities in pharmaceutical analysis. The reason for this is that unidentified, potentially toxic impurities are health hazards, and in order to increase the safety of drug therapy, impurities should be identified and determined by selective methods.

The aim of this review is to characterise the state-of-art in the field of impurity and degradation profiling of drugs based on papers published in the last decade. The separation and determination of impurities and degradants with a known structure are discussed, but emphasis is placed on the structure elucidation and determination of new (unknown) impurities and degradation products by off-line and on-line chromatographic–spectroscopic methods. The analytical aspects of enantiomeric purity of chiral drugs are also discussed.

药物杂质和降解特征分析意味着对散装药物原料和药物制剂中的杂质和降解产物进行检测，结构阐明和定量测定。今天，这是药物分析活动中最重要的领域之一。原因是未鉴定的，潜在的有毒杂质对健康有害，为了提高药物治疗的安全性，应通过选择性方法鉴定和确定杂质。

这篇综述的目的是根据最近十年发表的论文，对药物的杂质和降解特性分析领域中的最新技术进行描述。讨论了具有已知结构的杂质和降解物的分离和测定，但重点是通过离线和在线色谱-光谱法对新的（未知）杂质和降解产物的结构鉴定和测定。还讨论了手性药物对映体纯度的分析方面。