Researchers at Noramco study analytical methods to detect and determine the presence of potentially genotoxic impurities (PGIs) in pharmaceutical products. Devising a robust system to easily determine PGIs such as dimethyl sulfate (DMS) and monomethyl sulfate (MMS) is essential to verify finished products meet or exceed FDA guidelines.
A new study in Analytical Methods, entitled, “Determination of genotoxic impurities monomethyl sulfate and dimethyl sulfate in active pharmaceutical ingredients,” identifies novel, sensitive methods to rapidly, simply, and efficiently quantify MMS and DMS impurities in API-salts around the threshold of toxicological concern.
According to the authors, including Noramco’s Joshua Hoerner, the short run times of the methods, just 5 and 6 minutes for the analysis of MMS and DMS, respectively, make them easily and readily applicable to in-process monitoring of these impurities during pharmaceutical manufacturing.
Noramco, a major producer of specialty APIs, is committed to the best available analytical methods and processes that assure the production of ultra-pure specialty APIs.