Abstract
The radiolysis products of chloramphenicol under γ-radiation sterilization were investigated systematically. Eight main radiolysis products were identified and quantified by HPLC-MS and HPLC-DAD, including two compounds never before reported. The minor radiolysis products were quantified, which shows that they are at concentration levels<threshold for identification. Carbon-carbon rupture reaction and oxidation reaction are proposed as the main radiolysis reactions of chloramphenicol powder. The applicability of γ-sterilization for chloramphenicol products was evaluated quantitatively with qualitative and quantitative data that were compared to the threshold requirements of international regulations for identification. It was concluded that toxicities of the radiolysis products of chloramphenicol produced by γ-radiation sterilization can be neglected, the radiolysis products are safe for human health from the chemical view.
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