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Analyzing Residual Solvents Using GC Headspace and Valve-and-Loop Sampling

Thermo Fisher Logo

Thermo Fisher Scientific is pleased to announce a new gas chromatography (GC) method for the analysis and quantifying of residual solvents in pharmaceutical products and excipients as a result of the production process according to the U.S. Pharmaceutical Method (USP) 467.

In this method, concentration limits are set for each solvent, and 53 solvents are analyzed and grouped according to their health hazards, including Class 1, Class 2, and Class 3.

This method features the use of a valve-and-loop sampling system that simplifies headspace analytical methods, the Thermo Scientific™ TriPlus™ 300 Headspace Autosampler, which, combined with innovative chromatography software, met the analytical requirements of the USP Method 467 with full auditing capability.

Application Note 10136: Analyzing Residual Solvents in Pharmaceutical Products Using GC Headspace with Valve-and-Loop Sampling demonstrates the use of this sampling system combined with the Thermo Scientific™ Dionex™ Chromeleon™ CDS software and Thermo Scientific™ TRACE™ 1310 GC to demonstrate excellent resolution and reproducibility in this robust and convenient method for the detection of residual solvents in pharmaceutical products.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.


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