ELEMENTAL IMPURITIES: ICH Q3D
Limit potentially toxic elemental impurities in your pharmaceutical products.
Elemental impurities are traces of metals that can be found in finished drug products. Most of these metals are added intentionally as catalysts and reagents during the synthesis of the drug substance, but they can have other, unintended sources: impurities might already be present in the ingredients for the final product, or leach into the drug solution from equipment used in the manufacturing process.
Regardless of their origin, in accordance with the ICH Q3D guideline, the presence of potentially toxic elemental impurities in human medicines must be limited to ensure the safety of patients.
24 potential impurities:
More specifically, the guideline makes available a list of up to 24 potential impurities to check for, which we do as part of our service.Risk assessment & risk control:
By evaluating the elemental impurity levels, we’re able to assess the risk and form an according risk control strategy. We can, for instance, determine whether routine checks are necessary for your final product, or if there are steps in your manufacturing process that need to be modified.Maintenance along the lifecycle:
Since there’s always a possibility for changes to occur in the lifecycle of your product, such as modifications in your equipment, raw materials, or excipient suppliers, we also take care of maintenance along the way. This way we ensure the proper adjustments and re-evaluations in both risk-assessment and the according control strategies are considered.Special cases of justified higher levels:
In certain cases, it may be of advantage to justify levels of elemental impurity higher than the established PDE. The guiding principles are also described in the ICH Q3D guideline. We support you with the toxicological qualification and respective derivation of acceptable levels for elemental impurities higher than the PDE.Report & further measures:
Finally, we provide you with a detailed report and a personalized action plan based on the discovered results.
