New Panreac GC-Headspace grade solvents for the Pharmaceutical Industry

During the manufacturing of actives or excipients, or during the preparation of medicinal products, solvents that are used may not be completely removed. These solvents may have harmful effects on human health or on the environment and must be removed to the maximum extent possible. ICH’s Q3C guide (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) establishes the acceptable levels of residual solvents in pharmaceuticals and classifies them according to their toxicity.

It also describes the official methods for content analysis of said solvents in actives, excipients and/or medicines. The European Pharmacopoeia and the USP have adopted these same guidelines (Ph. Eur. Method 2.4.24 and USP <437>).

The method normally consists of dissolving the sample in an appropriate solvent (water, dimethyl sulfoxide or dimethyl formamide, among others) to remove the residual solvent. Subsequent analysis is done by Headspace Gas Chromatography.

Therefore it is important that the solvent to be used for dissolving the sample has maximum purity and contains none of the residual solvents to be analyzed.

At Panreac Química they are experts on solvent purification and control; they offer three of the most frequently used solvents in the preparation of samples for subsequent analysis by Headspace Gas Chromatography: Dimethyl Sulphoxide, N,N-Dimethylformamide and N,N-Dimethylacetamide.

To ensure the utmost quality of these new solvents it has been necessary to develop new, more demanding manufacturing and packaging protocols.

Learn more on our product website or contact your Panreac local dealer.