Volatile Organic Impurities and Residual Solvents

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.

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Automate and accelerate organic volatile impurity determinations by GC and GC-MS using the Thermo Scientific TriPlus 500 GC Headspace Autosampler. This dedicated static headspace sampling solution is ideal for regulated pharmaceutical workflows. Its innovative technological features offer reliable, unattended high-throughput operation that consistently delivers high quality results.

• Download TriPlus 500 brochure

Choose TRACE 1600 Series GC systems for time-proven performance and productivity. The Trace 1600 Series GC offers the reliability, robustness, and ease-of-use required for a modern routine laboratory, with a high degree of innovation for the best analytical performance.

• Download TRACE 1600 brochure

Streamline your laboratory workflow using Thermo Scientific Chromeleon 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.

• Download Residual Solvents eWorkflow method from AppsLab

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.

• Read white paper on residual solvents testing