Butterworth Laboratories offers comprehensive testing services following the United States Pharmacopeia (USP), European Pharmacopeia (PhEur), etc., which address the analysis of Residual Solvents, also known as Organic Volatile Impurities (OVIs), in pharmaceutical substances. Residual solvents are chemicals that are not completely removed during the pharmaceutical manufacturing process and can pose potential risks if present above acceptable levels.
Since the initial publication of USP <467> in 1988, Butterworth Laboratories has been at the forefront of residual solvent analysis. Over the years, we have continually enhanced our capabilities to meet evolving industry standards and client needs. In 1996, we implemented our first automated headspace Gas Chromatography (GC) system to address increased client demand for OVI testing. By 2005, we expanded to six headspace GC systems, enabling us to handle a significant rise in testing requirements. See our original Whitepaper on the subject, based on a presentation to a meeting organised by JPAG and the USP.
We utilise advanced headspace GC techniques to detect and quantify residual solvents in pharmaceutical products. Our procedures are aligned with the International Council for Harmonisation (ICH) Q3C guidelines, which classify solvents based on their toxicity and set permissible exposure limits. This ensures that our testing complies with USP <467>, PhEur 2.4.24 and adheres to global regulatory standards.
