Impurity Characterization and Management
FromCreative Biolabs
Impurities in pharmaceuticals devices may come from raw materials, reaction byproducts, or residual solvents. The potential and concentration of these compounds are usually taken into account during the risk assessment. And those impurities or contaminants would cause unexpected reactions in these processes, which may affect the API synthesis step or the medical manufacturing stages and may also affect the final stability and shelf life of API or medical device components. Therefore, the characterization and management of potentially problematic species is essential in the process of drug development.