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领域: | 生物制药/仿制药 | ||
样品: | Valve-and-Loop Sampling | 项目: | Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling |
参考: | USP |
方案文件名 | 下载 |
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Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling |
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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.