Lhasa Limited are pleased to announce the latest version of Zeneth, with impactful updates to align with the requirements in forced degradation study guidelines and improvement in prediction confidence.
Zeneth, a software application for the prediction of chemical degradation of small organic molecules, can help analytical chemists to solve several challenges that arise when carrying out forced degradation studies of active pharmaceutical ingredients or drug products. Read the recent post on the Lhasa blog to learn more about how Zeneth can support drug development workflows.
In response to valuable member feedback and to keep up to date with industry and regulatory demands, the following updates have been made:
Simulation and system defaults
The latest version of Zeneth introduces a new simulation defaults option in the prediction settings. This feature aligns with ICH guidelines, ensuring in silico predictions mirror the forced degradation conditions that must be experimentally tested. This update allows members to generate regulatory-compliant degradation predictions with ease, reducing manual adjustments and ensuring consistency in their studies.
The default prediction settings have been updated based on feedback received on how Lhasa members run predictions, and to align with the prediction settings used in the latest validation study.
Nitrosamine risk assessment
Nitrosamine fragment highlighting is now included in Zeneth, building on the nitrosamine risk assessment prediction type in Zeneth 10. This identifies potential risks within predicted degradants. Key functional groups, including N-N=O, C=N-O (oximes), and C-N=O (nitroso), are now visibly highlighted allowing members identify nitrosamine risk easily.
Advanced property calculators for more accurate predictions
The latest release introduces two new property calculators:
- pKaH
Used to identify the most reactive atom when multiple of the same type are present, to predict the most likely site of reaction that will be seen experimentally.
- Chromophore atom count
Guides wavelength selection when using absorption as a detection method, or it can be used to diagnose mass balance issues.
Expanded degradant property predictions
Zeneth now predicts additional physicochemical properties for degradants. By offering a comprehensive overview of degradant properties, Zeneth supports the design of suitable stability-indicating methods.
Excipient database enhancements for better formulation support
The excipient database in Zeneth now includes scientific comments on over 115 excipients, providing members with further insights into incompatibilities for formulation considerations. This addition supports more informed decision-making in pharmaceutical development.
Further updates in this release include:
- Improved performance and speed of predictions.
- Enhanced reporting capabilities.
- Ability to store and name degradation study condition sets.
To learn more about Zeneth or to arrange a demonstration, please visit our contact us page.
If you are an existing Zeneth user, you can explore the new features in Zeneth 10.1 or schedule a training session to support your upgrade.