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.
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.
高压离子色谱Inuvion快速测定自来水中的常见阴离子
高压离子色谱Inuvion快速测定生活饮用水中的亚氯酸 盐、溴酸盐、氯酸盐、二氯乙酸和三氯乙酸
Thermo Fisher Scientific iCAP TQe ICP-MS/MS测定土壤和沉积物多种元素
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