摘要
药物杂质是影响药物质量的重要因素,尤其是致突变杂质。盐酸司来吉兰中潜在存在两种新型的致突变杂质,探索了它们的合成方法并在药物中测定其含量,确定了它们的控制策略。
Drug impurities are important attributes that affect drug quality,especially mutagenic impurities.There are two potential new types of mutagenic impurities in selegiline hydrochloride.We explore their synthesis methods and determine their content in the drug to determine their control strategies.
作者
蔡玉磊
程俊
彭介伟
张祖良
王尧
田磊
CAI Yu-lei;CHENG Jun;PENG Jie-wei;ZHANG Zu-liang;WANG Yao;TIAN Lei(Anhui Biochen Biopharmaceutifcal Co.Ltd.,Hefei 230088,China)
出处
《安徽化工》
CAS
2024年第4期142-145,149,共5页
Anhui Chemical Industry
关键词
致突变杂质
盐酸司来吉兰
合成与分析
mutagenic impurities
selegiline hydrochloride
synthesis and analysis