Averica has built much of its reputation around identifying and often isolating pharmaceutical impurites
We have designed our laboratories to provide comprehensive impurity support for CMC specialists and product development teams from preclinical to commercial stages of development.
ICH Q3A/Q3B guidance documents define impurities as either organic, inorganic, or residual solvents. Organic impurities can develop from degradation or in the chemistry process. Inorganic impurities can come from reagents or catalysts, salts, or excipients. Residual solvents in drug substance or product may come from any step in a chemistry or manufacturing process. And any of these may come from packaging, labeling, shipping, or other exposure to external contaminants.
Our capabilities support many impurity related tasks:
Watch Lab Director, Paul Lefebvre, Explain Averica's Approach to Impurity Isolation
Solutions for your Impurity challenges
Impurity Profiling & Characterization
Confirm the structure of impurities or conduct pharmacologic or toxicologic studies on impurities, by rapid characterization using multiple approaches. We offer: