盐酸司来吉兰中两种致突变杂质的合成方法与含量测定
Synthesis Method and Content Determination of Two Mutagenic Impurities in Selegiline Hydrochloride
蔡玉磊 1程俊 1彭介伟 1张祖良 1王尧 1田磊1
作者信息
- 1. 安徽贝克生物制药有限公司,安徽合肥 230088
- 折叠
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.
Abstract
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 de-termine their content in the drug to determine their control strategies.
关键词
致突变杂质/盐酸司来吉兰/合成与分析Key words
mutagenic impurities/selegiline hydrochloride/synthesis and analysis引用本文复制引用
出版年
2024
NETL
NSTL
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