Simplify your USP <467> or ICH Q3C workflows

Solvents and volatiles identification and analysis in pharmaceuticals and biopharmaceuticals is essential, because they can be toxic to the patient or affect drug efficacy. We have proven, simple, compliant workflows for organic volatile impurities that follow regulatory guidelines, such as pharmacopeial chapter USP <467> Residual Solvents, and ICH Q3C Guideline for Residual Solvents.

Popular residual solvents products

Volatile organic impurities workflow


Featured technologies for USP <467> and ICH Q3C residual solvents
Automated headspace sampling for pharmaceutical residual solvent analysis

Automate and accelerate organic volatile impurity determinations by GC and GC-MS using the Thermo Scientific™ TriPlus™ 300 Headspace Autosampler. This comprehensive sample handling solution is ideal for regulated pharmaceutical workflows. Its valve-and-loop system offers reliable, unattended high-throughput operation.

   View the video: New Autosampler Designed for Fast Start-up, High-Productivity
Identify and quantify volatile pharmaceutical impurities

Choose Thermo Scientific™ ISQ™ Series Quadrupole GC-MS Systems for time-proven performance and productivity. The ISQ GC-MS series features a new source design that's ideal for continuous high-throughput operation. The vacuum interlock enables source removal without venting the system, enabling non-stop productivity in your laboratory.

Compliant software and methods for residual solvents analysis

Streamline your laboratory workflow using Thermo Scientific™ Chromeleon™ 7.2 Chromatography Data System (CDS) software. Run your routine GC or GC-MS residual solvent analyses in an enterprise environment—from method creation to final reporting. Download your USP <467> eWorkflow directly from our Thermo Scientific™ AppsLab Library. Your complete method and consumables shopping list in one click. Chromeleon software then delivers superior instrument control, automation, and data processing for compliant GxP pharmaceutical manufacturing and QA/QC environments.

 

Headspace grade solvents for pharmaceutical volatile organic impurities

In headspace GC analysis, the pharmaceutical compound of interest is often dissolved in a high boiling solvent to isolate trace amounts of volatile components. Although water is the most common solvent for this purpose, other solvents can be used when solubility of the pharmaceutical compound is an issue. Hear about our ultra-pure headspace grade solvents tested specifically for pharmaceutical volatile organic impurity testing following USP General Chapter <467> Residual Solvents.

Headspace grade solvents for pharmaceutical volatile organic impurities