When the drugs contain trace levels of genotoxic substances,there is a risk of causing tumors or even cancer,and the carcinogenic risk may not be correlated to the drug dosage.Therefore,at present,regulatory authorities in various countries strictly control genotoxicity impurities in drugs.This review systematically summarized the relevant literature and guiding principles both domestically and internationally for impurities in drugs,including their regulatory strategies,sources,detection methods and elimination strategies for genotoxicity impurities in drugs.This review provides a reference and guideline for the control/elimination and detection of genotoxicity impurities in drugs.
关键词
遗传毒性杂质/来源/检测方法/清除
Key words
Genotoxicity impurity/Source/Detection method/Clean up
维普
万方数据