Residual solvents in pharmaceutical products are defined as volatile organic chemicals. They are used or produced in the manufacture of pharmaceutical products or drug substances (benzene, acetone, cyclohexane, toluene, 1,4-dioxane…).
Solvent residues can be not only toxic but also detrimental to the manufacturability and stability of the finished product. Because of the consequences on the quality of the product, specifications have been set at international level for each solvent.
Therefore, it is essential to analyze your products to ensure that they comply with the relevant regulations.