Doxorubicin Contamination on the External Surfaces of Drug Vials

Abstract

Contamination of the external surfaces of drug vials with antineoplastic drugs has been reported in some countries. However, this has rarely been reported in Japan. The aim of this study was to investigate the external contamination level of doxorubicin vials in Japan. The external surfaces of 57 vials of six products containing doxorubicin were wiped with a non-woven fabric, and the contamination levels of doxorubicin were analysed by high-performance liquid chromatography combined with fluorescence detection; doxorubicin was confirmed by high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry. The surfaces of 28 of 57 vials were contaminated with doxorubicin. The maximum contamination level was 12.3 ng per vial. The external surfaces of some doxorubicin product vials produced by Japanese pharmaceutical companies were contaminated with doxorubicin.