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Elemental Impurities

Supporting more scientifically driven risk assessments under ICH Q3D

Elemental impurities in drug products may arise from several sources and may be present as impurities in drug products.

Implemented in 2018, the ICH Q3D guidance presents a process to assess and control elemental impurities in the drug product using the principles of risk management. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

The guideline introduces permitted daily exposure (PDE) limits for 24 elements. It is widely known how to apply PDEs in industry; however, there remains an incomplete picture of the levels present in all formulations.

Our solution

The Elemental Impurities data sharing initiative shares analytical data on the levels of trace elements in excipients to support more scientifically driven ICH Q3D drug product risk assessments.

The Vitic Elemental Impurities data sharing initiative can support your drug product elemental impurities risk assessment.

Key highlights

Access high quality data on the levels of trace elements in excipients
The Elemental Impurities database is the largest of its kind and continues to grow. Our scientists expertly curate, and peer review the shared data, meaning you can make more informed decision making.

Manage ICH Q3D submission
Conduct more scientifically driven ICH Q3D assessments by utilising data that has the same origins as published literature. Our elemental impurities excipient database can be used in assisting the execution of a drug product elemental impurities risk assessment, as required by the ICH Q3D guidelines.

Streamline your risk assessment workflow
The sharing of data minimises duplication of testing across companies and reduces the burden of analytical testing for elemental impurities in excipients, saving you time and money.

Regulatory support


The Elemental Impurities initiative continues to aid industry data sharing and support ICH Q3D assessments by making propriety data easily accessible to both industry and regulators via a custom curated database.

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