Various solvents are used in the manufacturing Active Pharmaceutical Ingredients (API) and at times residual solvent impurities find their way into the finished formulation. The residual solvent impurities are primarily trace amounts of volatile organic compounds which are used for production of drugs but are present in the final drug product. Whereas Class 1 solvents have unacceptable level of toxicity, Class 2 has high toxicity and Class 3 is lease toxic in nature.
Since even a trace amount of these solvents can adversely impact the safety and efficacy of the drug, close monitoring is required. According to regulatory guidelines, these residual solvents must be within the Permissible Daily Exposure (PDE). It is therefore important for the manufacturer to ensure that the solvents remain within PDE. At VIMTA, all residual solvent studies are performed in accordance with defined USP Residual Solvents <467> method.