Lhasa Limited is pleased to announce the release of new data to the Vitic Elemental Impurities database. This pre-competitive data sharing initiative facilitates anonymous sharing of analytical data on the levels of trace elements in excipients.
With the latest update, the Vitic Elemental Impurities 2025.1.0 database now contains:
- 99 new data records, increasing the total to 3,149.
- This data covers 306 excipients of which 6 are new excipients.
Why an Elemental impurities data sharing initiative?
Elemental impurities 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.
Importance of ICH Q3D guidance
The guideline introduces permitted daily exposure (PDE) limits for 24 elements. While it is widely known how to apply PDEs in industry, there remains an incomplete picture of the elemental impurities levels present in excipients . The Lhasa Vitic Elemental Impurities data sharing initiative shares and harmonises this data, helping organisations to conduct their ICH Q3D risk assessments for excipients.
Help with your ICH Q3D risk assessments
Is your organisation currently conducting ICH Q3D risk assessments for their drug products? Get in touch with the team today to discuss how you could utilise the Elemental Impurities database for your assessments!
This database is the largest of its kind and has been curated by experts. As a result, it has minimised the duplication of testing across companies, reducing the burden of analytical testing for elemental impurities in excipients – saving both time and money.
Speak to a member of the Lhasa team today to discuss your Q3D requirements.