Assay for Parts-Per-Million Levels of Azide in Drug Substances

作者:Wrezel P W*; Lutz M R Jr; Likhotvorik I; Cao J
来源:LC-GC North America, 2012, 30(11): 986-991.

摘要

The removal of azide as a potential impurity from a drug substance may be critical to its safety profile, such that quantitation of this impurity becomes an important control parameter. This paper describes a simple and practical assay for azide using chemical derivatization and high performance liquid chromatography. The method is shown to be suitable for the intended purpose on three example test materials. Potential issues for wider applications are discussed.

  • 出版日期2012-11