What’s New
We are delighted to release our new version of Impurity Profiling Suite ™, Version 2026.
Highlighted Features
- Enhanced Ames test predictor.
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Streamlined ICH M7 classification.
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Improved CPCA categorization of N-Nitrosamines.
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Further Details
Version 2026 introduces improvements to ICH M7 classification workflows, enhanced N-nitrosamine CPCA categorization, expanded literature references, and a major update to the Ames Test predictor training library.
Algorithm Improvements
Enhanced Ames Test Predictor
You can now expect greater accuracy of the Bacterial Composite (Procaryote Mutagenicity) predictor.
Improvements include:
- Significant expansion with experimental data for ~7000 new compounds (64% increase in database size).
- Integration of data from a large comparative study combining multiple public genotoxicity databases.
- Additional curation of experimental results to resolve conflicting data from different sources.
Classification
Streamlined ICH M7 Classification
- You can now perform ICH M7 assessments more efficiently with clearer classification outputs, improved reporting, and enhanced handling of parent-derivative analyses. You can expect greater transparency and simplified interpretation of ICH M7 results.
- Key improvements include:
- ICH M7 calculations in Spreadsheet now include an additional Ames test field displaying the final mutagenicity prediction (Positive, Negative, or Undefined) in a simple text format.
- In parent-derivative analyses, the parent molecule is now clearly identified as the API, reducing ambiguity and ensuring it is evaluated independently from its derivatives.
- Compounds with inconclusive predictions are now assigned Class 3 rather than returning a numerical value of "0", helping ensure potentially relevant compounds receive appropriate attention while clearly indicating when expert review may change the outcome.
- PDF reports now include more detailed explanations of classification comments to support interpretation and decision making.
- Experimental Ames negative data can now take precedence over positive findings in other endpoints, enabling Class 5 assignments where appropriate.
Experimental Ames negative data enables Class 5 assignments where appropriate.
Improved CPCA categorization of N-Nitrosamines
- You can expect better alignment of Impurity Profiling Suite results with publicly available FDA reference data when assessing N-nitrosamine impurities. The CPCA categorization algorithm for N-nitrosamines has been revised to more closely match the methodology used to generate FDA-published CPCA scores and category assignments.*
* Minor differences may still occur due to differences in tautomer handling and software architecture.
Ease of Use
Additional Reference Information for Supporting Data
You can now view the references for supporting experimental data sources directly in the Impurity Profiling module interface and ICH M7 classification reports for:
- Similar structure listing for Ames Test.
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TD50 listings for Rat Composite and Mouse Composite Carcinogenicity, which now also indicate when data has been obtained from the Carcinogenic Potency Database (CPDB).