In the pharmaceutical industry, volatile organic substances (VOCs) that can occur from solvents used during the production of drugs and pharmaceutical substances and have the potential to pass into the formulation of finished products are called residual solvents. Due to the potential of these solvents in the final product, drug manufacturers are required to prove that their products do not contain toxicologically unlimited amounts of volatile organic compounds in order to guarantee patient safety. According to the guidelines and standards published by the authorities, residual solvents must remain within the permitted daily exposure limits (PDE).
Unless requested by any other guideline, residual solvent determination analysis, separation of volatile compounds and purity determination are performed by gas chromatography (GC) in our laboratory according to ICH Q3C and USP <467> guidelines.