Elemental impurities in pharmaceuticals can come from various sources; they may be residual catalysts that were intentionally added in synthesis or they may be present as impurities (for example, through interactions with processing equipment or packaging/closure systems or by being present in the product drug components). Since elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug must be controlled within acceptable limits.
Fernando Tazón, manager and founder of Grupo Asinfarma, presents us with a guide with three very important parts:
evaluation of toxicity data for possible elemental impurities; establishing a Permitted Daily Exposure (PDE) for each element of toxicological concern and applying a risk-based approach to control elemental impurities in pharmaceuticals.
This guide presents a process to assess and control elemental impurities in drug product using risk management principles as described in ICH Q9. This process provides a platform to develop a risk-based control strategy to limit elemental impurities in the drug product.
The full study can be accessed at the following link.