Discussion on acceptance limit of drug metabolites in quality standard

VernacularTitle:药物代谢产物在质量标准中可接受限度探讨
Author: Yunfei LIU ¹ ; Lingbo WANG ; Xiulan WU ; Jia YU ; Hao ZHOU ; Lihong YANG
Author Information

1. 正大天晴药业集团股份有限公司,南京 211112
Keywords: related substance; metabolites; qualification; acceptable limit; quality standard; impurity
From: Drug Standards of China 2024;25(5):526-528
CountryChina
Language:Chinese
Abstract: 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.