Version 2021 of Impurity Profiling Suite adds new features to help you interpret the predicted results and prepare compound safety reports. Other improvements have also been made to the software. Read below for details, and contact us for help upgrading your software.
You can now see the ICH M7* classification for your compound in the software with additional information to help you interpret the results
- *ICH M7 is the ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit the potential of carcinogenic risk
- The software provides the following classifications, based on experimental data and QSAR predictions:Ϯ
- Class 1—Known carcinogen
- Class 2—Known mutagen
- Class 3—Alerting/potentially hazardous structure
- Class 5—No alerts or sufficient data for lack of mutagenicity
- Ϯ Class 4 assignments for parent-derivative relationships are not provided by the software at this time.
- When a definitive classification cannot be made, ICH M7 Class is reported as Inconclusive. This result should be treated as requiring further attention, as for Class 3.
- The reasoning for the class assignment and recommendations for appropriate control measures are provided with the classification.
- When a definitive classification cannot be made from experimental data alone, the software provides information based on evaluation using a WOE (weight of evidence) approach involving:
- The probability of hazardous effects reported by statistical models and confidence of predictions
- Presence of alerting groups known from the literature
- Evidence from experimental data for the most similar compounds from the built-in database
- Other mitigating factors
You get even more information for batch predictions in the Spreadsheet Workspace:
- Number of confident positive calls produced by statistical models for different endpoints
- Number of hazardous substructures identified
This additional information serves as a summary of all predictions and highlights the contributions of both statistical and expert system approaches, as required by regulatory guidelines.
You can report your ICH M7 assessments directly to PDF.
- The report summarizes the most relevant information for you to review and make decisions from. It may also serve as the foundation for reporting toxicological safety profiles of impurities and degradants to regulatory authorities.
You can now see the parameters that compose the Reliability Index (RI) for GALAS models in the Spreadsheet Workspace
- Better understand reliability by seeing the Similarity Index (SI) and the Data-Model Consistency Index (DMCI) alongside the predicted results
We’ve made it easier for you to configure Context Help.
- You can now activate and deactivate extended tooltips from the Expert panel.