Version 2024 of Impurity Profiling Suite includes an update to the regulatory classification according to the ICH M7 Guideline. Read below for details, and contact us for help upgrading your software.
Transition to the ICH M7 (R2) Guideline
With the latest update to the algorithm for ICH M7 classification accounting for the R2 revised guideline released in 2023, you can have confidence that your regulatory submissions will comply with the current ICH M7 guidelines.
In this new revision, the principles of hazard evaluation have remained unchanged, but the guideline has been supplemented with an addendum listing some commonly encountered impurities that have been extensively studied and have well-established tolerable limits of exposure. The current release of Percepta checks the submitted compounds against this known dataset and matches are automatically assigned Class 1 (compound with known carcinogenic potential). Allowed exposure limits, as indicated in the Guideline, are also cited.
Enhanced Ames Test Predictor
You can now expect greater accuracy of the Bacterial Composite Mutagenicity (Ames Test) predictor. Improvements include:
- Addition of >100 new compounds to the training data set
- Expansion of data encompassing recently approved drugs, food additives, and known impurities in pharmaceutical products
Want to learn more?
Read more about the full features of Impurity Profiling Suite, or contact us for help upgrading your software.