Objective To summarize the ideas behind test methods established for insoluble samples in the Chinese Pharmacopoeia and related literature in China over the past 10 years,and to provide reference for endotoxin detection of insoluble APIs,excipients and preparations.Methods The determination of endotoxin limits,inspection methods,dissolution methods,and strategies for excluding interferences in domestic literature on insoluble samples were analyzed by focusing on the selection of organic solvents.Results and conclusion The difficulty in establishing a method for the detection of bacterial endotoxin in insoluble samples lies in the search for suitable solvents and the elimination of interferences.Dissolution methods involve organic solvents,non-organic solvents and physical methods,while the elimination of interferences involves the adjustment of pH,the supplementation of divalent cations,and the use of antiproliferative fluids and dispersants.This study is expected to inspire ideas for subsequent research.
关键词
原料药/辅料/制剂/细菌内毒素/鲎试剂/难溶性/方法学/质量安全/排除干扰
Key words
raw materials/excipients/preparations/bacterial endotoxin/TAL/insolubility/methodology/quality safety/elimination of interference
维普
万方数据