This paper discussed how to set the limit of impurities in the quality standard when the impurities in small-molecular innovative drugs were metabolites.Firstly,through the analysis and interpretation of each relevant guideline,in combination with the review cases of FDA and EMA,found out the conditions for qualification of im-purity,and then establ ish the acceptable limit of impurities based on the test results of multiple batches,the incre-ments of production process and storage process.
关键词
有关物质/代谢产物/界定/可接受限度/质量标准/杂质
Key words
related substance/metabolites/qualification/acceptable limit/quality standard/impurity
维普
万方数据