Residual Solvents Testing
Representing nearly 95% of GC testing at R.D. Laboratories, residual solvents 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. Previously referred to as organic volatile impurities (OVIs), residual solvents can also be byproducts formed during packaging and storage of the drug product.
Our analysts have extensive experience in optimizing gas chromatographic methods and examining volatile organic compounds in a variety of matrices. We have multiple gas chromatographs with a variety of injection and detection techniques. All equipment is fully validated (IQ/OQ/PQ) and system suitability is performed using traceable reference standard residual solvent solutions to satisfy current Good Manufacturing Practice regulations.
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