化学药品杂质控制的现状与展望

被引：53

作者：

胡昌勤

机构：

[1] 中国药品生物制品检定所

来源：

中国科学:化学 | 2010年 / 40卷 / 06期

关键词：

化学药品; 杂质谱; 杂质分析; 杂质鉴别; 杂质评估;

D O I：

暂无

中图分类号：

R927.2 [药物含量测定];

学科分类号：

1007 ;

摘要：

对药品中杂质的控制是保证药品用药安全的重要环节.伴随着对药品杂质特性的深入了解,依据杂质的生理活性逐一制定每一个杂质限度的"杂质谱控制"理念已经被国内外普遍接受.与"杂质谱控制"相关的关键技术问题可概括为:复杂体系样本的分离分析、微量组分的结构分析和微量组分的毒性评价三方面.本文从杂质控制理念和杂质分析技术两方面,综述了化学药品杂质控制的现状,并就今后的发展提出自己的观点.

引用

页码：679 / 687

页数：9

共 65 条

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