Effective, July 1st, 2008, the title of General Chapter <467> will be changed from Organic Volatile Impurities to Residual Solvents. United States Pharmacopoeia (USP) has updated General Chapter <467> to include ICH Q3C which will allow only acceptable amounts of residual solvents in pharmaceuticals.

Residual solvents are the organic volatile chemicals that are used or produced during the process of manufacturing drug substances or excipients, or during the preparation of drug products. Because there is no direct benefit, most levels of residual solvents should be removed to meet quality-based requirements.

United States Pharmacopoeia (USP) General Chapter <467> Residual Solvents came about from the help of the International Conference on Harmonization (ICH) Q3C Expert Working Group in addition to the European Pharmacopoeia (PhEur). ICH had completed standards to control the levels of residual solvents during the 90s. Later that decade, these standards were adopted by the PhEur. USP, however, chose to hold off on adopting the standards until the industry developed a more consistent approach to applying the ICH guideline.

From our state-of-the-art instrumentation to our highly experienced team of scientists, Irvine Pharmaceutical Services can quantify and qualify traces of residual solvents in just a few days. Even better, Irvine has an extensive history of developing and validating test methods, creating over 300 methods since Irvine’s start 20 years ago.

Irvine’s QC Laboratory can help you with vendor and contract manufacturer qualification. Providing this essential service to the pharmaceutical industry has earned Irvine Pharmaceutical Services a solid reputation both in the United States and abroad. We maintain an extensive inventory of compendial grade reference standards and have much experience performing the more unusual and demanding methodologies.