Vitic Q3D assessments
Supporting calculations of elemental impurities for ICH Q3D risk assessments.
Conduct your elemental impurity assessments for ICH Q3D using Vitic Q3D, our in silico solution leveraging an expert-curated database – saving you up to 50% of the time typically required to run an assessment.
Speak to the team today on how you can confidently identify your impurity sources, develop your control strategies, and comply with regulatory expectations.
Access to industry-trusted elemental impurity database
Mitigate the need for elemental impurity testing in-house, with access to public and proprietary data curated by industry suppliers.
Confidently define control strategies to manage elemental impurity risk
Generate automated calculations for ICH Q3D options 1, 2A and 2B simultaneously, to guide control options for your drug product.
Maintain regulatory compliance with Q3D report generation
Produce reports ready for instant Q3D submission, alongside secure assessment storage in the software for future product life-cycle management.
Vitic Q3D harmonises your assessments by performing automated calculations using a curated, high quality elemental impurities database.
Vitic Q3D was developed to help pharmaceutical companies mitigate the need for in-house analytical testing of elemental impurities, and streamline the time and resource demanded by Q3D assessments.
- Supports the development of formulations that comply with Q3D requirements
- Helps analytical chemists accurately detect and quantify elemental impurities, via a reproducible, validated method.
- Enables quality control analysts to provide reliable, repeatable results for regulatory submission.
- Supports batch release with verified impurity data.
Request a Vitic Q3D demonstration
Conducting your ICH Q3D assessments with Vitic Q3D
- Access to a simple step-by-step user workflow with automated impurity suggestions.
- Leverage industry-leading database to identify elemental impurity sources in your API and excipients.
- Simplify compliance with automated calculations, producing all three category results simultaneously.
- Establish control strategies for individual impurities present in APIs and excipients.
- Store and update risk assessments for future product life-cycle management.
Explore our other in silico solutions that can help you identify and control impurities in Active Pharmaceutical Ingredients (APIs) and final drug products: Mirabilis and Zeneth.