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

发布时间: 2018-04-22 17:12 来源: 赛默飞色谱与质谱分析
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

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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.

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