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. The acceptable levels of residual solvents in pharmaceuticals are described and also the official methods to determine the content in the pharmaceutical samples.
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 ITW Reagents we are experts on solvent purification and control; we offer the most frequently used solvents in the preparation of samples for subsequent analysis by Headspace Gas Chromatography. To ensure the utmost quality of these new solvents it has been necessary to develop new, more demanding manufacturing and packaging protocols.