氘代药物原料药质量控制要素分析

Analysis on the quality control of active pharmaceutical ingredients of deuterated drugs

氘代药物是指对某种药物分子上特定位点进行1个或多个氘-氢原子替换所获得的药物,由于其明显的药动学优势而广受关注。目前,国内外已有多个氘代药物获批上市。但目前国内外缺少专门针对氘代药物的质量控制标准和指导原则,本文作者结合现有文献和氘代药物质量分析及标准复核工作中所积累的经验,对氘代药物的分析方法和质量控制进行了初步梳理和探讨,对氘代药物原料药鉴别、氘代率测定、杂质检查等进行阐述,以期为氘代药物原料药的质量控制提供参考。

Deuterated drugs are obtained by substituting deuterium and hydrogen atoms at specific sites on drug molecules, which are receiving considerable attention due to the advantages on pharmacokinetics. A number of deuterated drugs have been approved in China and abroad at present. Currently, there are no established guidelines from the FDA or other governing bodies outlining how to address deuterated APIs. In this paper, the specificity of quality control of deuterated drugs, especially identification, deuterated ratio and impurity test, was discussed based on the documents, quality analysis and validation, and verification of quality specification on deuterated drugs, in order to provide a reference for the quality control of deuterated drugs.