Identifying and describing the impurities that are present in prescription medicines is important for safety reasons, since some impurities can be hazardous to the health of the person using the medicine.
Impurities can arise during the process of manufacturing or storage of medicines.
They can be either:
related to the drug substance (e.g. starting materials, by-products, intermediates that arise during synthesis, degradation products)
unrelated to the drug substance (e.g. residual solvents, residual metal catalysts, reagents used during synthesis, chemicals that leach from the container).
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.