Residual solvents, previously referred to as organic volatile impurities (OVIs), are trace level chemical residues that are used or produced in the manufacture of drug substances and excipients or in the preparation of drug products. They can also be byproducts formed during packaging and storage of the drug product.
R. D. Laboratories, Inc. is uniquely qualified to assist you with your residual solvent testing needs. Implementing USP <467> requires specialized equipment with careful selection of chromatographic supplies and operating parameters. Our analysts have extensive experience in optimizing gas chromatographic methods and analyzing volatile organic compounds in a variety of matrices.
R. D. Laboratories, Inc, has multiple gas chromatographs with a variety of injection and detection techniques.
All equipment has been fully validated (IQ/OQ/PQ) and system suitability is performed using traceable reference standard residual solvent solutions to satisfy current Good Manufacturing Practice regulations.