Unexpected assay results
Investigate changes in analytical response, recovery or repeatability.
Stability & problem solving
Stability Studies and Analytical Troubleshooting
Analytical support for investigating changes over time, unexpected results and challenging laboratory problems during pharmaceutical development and quality-control work.
Investigate results, understand trends and identify next steps
Unexpected analytical results can arise from product changes, sample handling, method performance, instrument conditions or interactions between these factors. Phanso provides focused analytical investigation to help identify plausible causes and determine what to examine next.
Phanso also conducts stability studies for pharmaceutical products, including the storage of samples under agreed conditions and the assessment of stability over time. Study design, storage conditions, test methods, sampling time points and reporting requirements are defined for each project. Stability studies can be combined with analytical investigations to support the evaluation of product stability, assay changes and degradation-related trends.
Areas of support
- Analytical testing of stability samples within an agreed scope
- Investigation of assay changes and degradation-related peaks
- HPLC/UPLC troubleshooting, including peak shape and resolution
- Investigation of sample preparation, recovery and reproducibility
- Review of analytical trends and unexpected results
- Follow-up method optimization where required
Examples of problems to investigate
Focused troubleshooting can help distinguish a product-related change from an analytical or sample-handling issue.
New or changing peaks
Assess chromatographic changes and develop suitable follow-up investigations.
Chromatographic performance
Investigate retention, resolution, peak shape, baseline behaviour or pressure changes.
Stability trends
Evaluate analytical results over time within the agreed study design and test scope.
Need help understanding an unexpected result?
Share the product, method, observed change and any relevant study conditions.