Merck SupraSolv solvents N,N-Dimethylformamide and Dimethyl sulfoxide for headspace gas chromatography

Merck has introduced N,N-Dimethylformamide and Dimethyl sulfoxide, two SupraSolv solvents designed to meet the requirements of headspace gas chromatography: high purity and low concentrations of residual solvents, as defined by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).

The solvents are optimised for the analysis of residual solvents in drug substances, excipients and drug products in accordance with ICH guideline Q3C ‘Impurities: Guideline for Residual Solvents’. This guideline divides all residual solvents into three classes according to how harmful they are to human health and defines permissible maximum concentrations in drug substances and products. Both the European Pharmacopoeia (Chapter 2.4.24) and the United States Pharmacopeia (Chapter <467>) refer to this guideline.

For these solvents, the company specifies precisely the concentrations of the various residual solvents defined in the ICH guideline. In addition, a headspace application test is performed for every batch produced.