Establishment of a Knowledge Base for Prescreening Residual Solvents in Pharmaceuticals

被引：11

作者：

Li Qin

Chang-qin Hu

Li-hui Yin

机构：

[1] National Institute for Control of Pharmaceutical and Biological Products,

[2] Yunnan Institute for Drug Control,undefined

来源：

Chromatographia | 2004年 / 59卷

关键词：

Gas chromatography; Static headspace sampling; Residual solvent in pharmaceutical; Solvent data base;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

A knowledge base for determining residual solvents in pharmaceuticals has been established using static headspace gas chromatography (HS-GC). Fifty-one solvents which belong to four different classes according to the guideline for residual solvents regulated by the International Conference on Harmonization were studied. Two columns with opposite polarity, SPB-1 and HP-FFAP, were used and the relative retention time was the qualitative parameter in the knowledge base. With the aid of the knowledge base, unknown residual solvents in pharmaceuticals can be identified promptly and suitable methods for determining residual solvents can be developed rapidly.

引用

页码：475 / 480

页数：5