Complying with USP <467> and ICH Q3C methods.
Solvents are often necessary for the manufacture of drug products, as they can improve yield and solubility and enhance crystallization. However, depending on their toxicity and concentration, they can be harmful to the patient. Determination of residual solvents is critical to ensure that pharmaceutical raw materials and finished products are safe.
Exova conducts residual solvent testing in compliance with USP <467> and ICH Q3C. Most of the residual solvents listed can be determined by USP <467> and ICH Q3C while some others require methods to be developed specifically and validated. Exova also offers testing by our internal GCMS methods.
Working closely with our clients, we look for potential sources of solvent contamination, assist in working to eliminate these from your products and help to resolve difficult out of specification issues related to solvents. The USP <467> and ICH Q3C residual solvents methods can be performed on a rush basis to meet your business needs.