Forced degradation prediction can generate significant results volumes. Soft spots functionality in Zeneth gives analytical chemists a systematic route to the structural areas of an API (active pharmaceutical ingredient) most susceptible to degradation.
Forced degradation prediction for a complex API can generate a significant volume of results. Identifying where to focus analytical effort across those results has traditionally depended on scientific experience and judgement. The new soft spots functionality of Zeneth makes that prioritisation systematic, reproducible, and documentable.
The update is available to all current Zeneth members as part of their existing subscription.
Soft spots functionality includes:
- Structural prioritisation: the software identifies the regions of the API most susceptible to degradation across oxidative, hydrolytic, and photolytic stress conditions, giving analysts a ranked starting point before experimental work begins
- Prediction filtering: users can filter the full set of Zeneth forced degradation predictions to the pathways associated with identified soft spot regions, reducing the volume of results to those most relevant to each stress study
- ICH Q1A(R2) and ICH Q1B alignment: each soft spot descriptor maps directly to a specific ICH stress condition, supporting a risk-based study design with a clear mechanistic rationale
- Regulatory documentation support: the soft spots analysis provides a documented, structure-based justification for forced degradation study design that can be referenced in submissions
“The challenge scientists increasingly face is justifying the design of their forced degradation studies. The new soft spots functionality in Zeneth 10.2 provides a documented, ICH-aligned rationale for study design decisions.” Jonathan Lockett, Lead Scientist Zeneth, Lhasa Limited
The soft spots functionality was developed in close collaboration with the Zeneth member community, reflecting direct feedback from analytical and regulatory scientists on the practical challenges of working through large forced degradation prediction results.
With regulatory expectations for risk-based, mechanistically justified forced degradation study design continuing to grow, the update gives Zeneth members a tool that supports both study efficiency and submission quality.
Soft spots functionality and other updates are available in Zeneth 10.2. Current members can download now. To arrange a demonstration or find out more, contact the Lhasa team.