New SupraSolv® solvents for headspace gas chromatography
- Analyis of residual solvents in drug products with SupraSolv®
For the analysis of residual solvents in actives, excipients and drug products according to ICH, Ph. Eur. and USP
Headspace gas chromatography is a very precise and well accepted method for the analysis of residual solvents in drug substances and products according to the ICH (International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), USP and Ph. Eur.
One challenge when working with headspace gas chromatography is to find a solvent quality that does not interfere with the analysis because it contains undefined levels of residual solvents. Merck has now introduced two new SupraSolv® solvents N,N-Dimethylformamide and Dimethyl sulfoxide which are especially designed for the sophisticated needs of headspace gas chromatography: high purity and extremely low concentrations of the residual solvents as defined by the ICH.
| Your benefits |
|---|
|
Developed and specified in accordance with international standards
SupraSolv® solvents for headspace gas chromatography are optimized for the analysis of residual solvents in drug substances, excipients and drug products according to the ICH guideline Q3C "Impurities: Guideline for Residual Solvents". This guideline divides all residual solvents into three classes according to their harmfulness to human health, and defines permissible maximum concentrations in drug substances and products. Both the European Pharmacopeia (Chapter 2.4.24) and the United States Pharmacopeia (Chapter <467>) refer to this guideline.
Outstanding solvent quality
Merck offers an incomparable application-oriented quality that helps you to achieve accurate and reliable analytical results.
For our headspace solvents we exactly specify the concentrations of the various residual solvents of the three classes defined in the ICH guideline. Additionally, we perform a headspace application test for every batch produced. This gives you the application reliability you need for your daily work.
Find out more about solvents for headspace gas chromatography SupraSolv®
