Bailun Testing Wins Kunming Pharma Genotoxic Impurity Assessment Project

Hangzhou Bailun Testing Technology Co. , Ltd. , a wholly owned subsidiary of Baicheng Pharmaceutical, has recently won the bid for Kunming Pharma Group Co. s "Genotoxic Impurity Assessment Unit Price Framework Procurement Project." Kunming Pharma is an affiliate of China Resources Pharmaceutical Group Limited. The collaboration focuses on the assessment of genotoxic impurities in pharmaceutical products.

Under this engagement, Bailun Testing will strictly align with ICH M7, NMPA, FDA, and EMA guidelines, the leading domestic and international regulatory frameworks, to provide Kunming Pharma with forward-looking mutagenicity risk prediction and classification for process impurities, degradation impurities, and process residuals. This will assist the company in establishing impurity control limits. Quantitative structure–activity relationship (QSAR), an internationally accepted computational toxicology technique, leverages compound molecular structure to rapidly predict potential mutagenicity and toxicity risks.