Monitoring of Polymorphism - From Detection to Quantification

被引：14

作者：

Giron, D. ^{[1
]}

机构：

[1] Novartis Pharmaceut, Chem & Analyt Res & Dev, CH-4002 Basel, Switzerland

来源：

ENGINEERING IN LIFE SCIENCES | 2003年 / 3卷 / 03期

关键词：

Polymorphism; Pharmaceutical products; Crystallization;

D O I：

10.1002/elsc.200390012

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

The polymorphic behavior of organic substances is driven by thermodynamic and kinetic factors. Therefore several solid phases may coexist. Since the properties of the solid state may be extremely relevant for the quality of medicines, the International Conference of Harmonization (ICH) requires a polymorphic study for new active ingredients. The different steps of investigations and the analytical methods which are used during the development phase in order to achieve adequately this challenging task, from detection to quantification are emphasized.

引用

页码：103 / 112

页数：10

共 21 条

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