Impurity Analysis
Trace impurities in API’s and excipients originate from a number of sources such as manufacturing equipment, packaging and handing as well as from chemicals and reagents use in processing. These impurities can be present in the form of trace residual solvents, degradation products or metal catalysts and require a wide repertoire of specialized analytical equipment and qualified personnel for adequate characterization.
Control of these contaminants is a requirement of a number of international guidelines, for example EMEA CPMP/ SWP/ QWP/ 4446/ 00 or ICH Q3A, B, or C. Maxxam has the capabilities to enable our customers to meet this challenge.
