Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling

2018/04/22   下载量： 1 次

方案摘要

方案下载
应用领域 制药/生物制药
检测样本
检测项目
参考标准 USP

All the USP <467> method acceptance criteria were met, and the chromatograms show good peak shapes and resolution. These data demonstrate that headspace-gas chromatography is a quantitative technique that easily meets the requirements of the USP <467> method. The system configuration of the TRACE 1310 GC, TriPlus 300 Headspace, and Chromeleon CDS is a solid, fully integrated, and reliable platform to perform the analysis according to the USP <467> method with full auditing capability. Operating this system configuration and method in a regulated environment is highly possible obtaining accurate, dependable results.

方案下载
配置单
方案详情

US Pharmacopeia (USP) method <467> delineates the
procedure to identify and quantify any organic volatile
solvent present in pharmaceuticals and excipients as a
result of the production process. The method details the
chromatographic system and analytical conditions to be
used and addresses the acceptable limits for each solvent.
This application note describes the analysis of residual
solvents in accordance with USP method <467> using the
Thermo Scientific™ TRACE™ 1310 GC, the new Thermo
Scientific™ TriPlus™ 300 Headspace autosampler, and 
the Thermo Scientific™ Dionex™ Chromeleon™
chromatography data system (CDS) software.

All the USP <467> method acceptance criteria were met, and the
chromatograms show good peak shapes and resolution. These data
demonstrate that headspace-gas chromatography is a quantitative technique
that easily meets the requirements of the USP <467> method. The system
configuration of the TRACE 1310 GC, TriPlus 300 Headspace, and
Chromeleon CDS is a solid, fully integrated, and reliable platform to 
perform the analysis according to the USP <467> method with full auditing
capability. Operating this system configuration and method in a regulated
environment is highly possible obtaining accurate, dependable results.

上一篇 高压离子色谱Inuvion快速测定自来水中的常见阴离子
下一篇 顶空气相色谱法测定阿米舒必利中有机溶剂残留量

文献贡献者

赛默飞色谱与质谱
钻石会员 丨 第23年
查看全部资料
相关仪器 更多
相关方案
更多

相关产品

当前位置： 赛默飞色谱与质谱 方案 Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling

关注

拨打电话

留言咨询