The world's first AI-powered pharmaceutical stability prediction system. Proprietary computation engines. Zero guesswork. ICH-aligned predictions you can trust.
Every prediction flows through four scientifically rigorous phases — from intelligent literature synthesis to precision kinetic computation.
Our proprietary AI engine performs comprehensive literature analysis for the specific API — extracting key stability parameters, degradation profiles, excipient interactions, and published reference data.
14 proprietary computation engines run sequentially — covering kinetic analysis, environmental corrections, packaging performance, excipient assessment, and comprehensive shelf-life modelling.
Cross-checks computed results against published data, verifies ICH Q3B compliance for every degradant, validates mass balance, confirms confidence score consistency.
A fully automated template engine generates a comprehensive 18-section report. Every number is traceable to a validated computation — ensuring complete accuracy and reproducibility.
Our proprietary engine architecture ensures every prediction is reproducible, traceable, and scientifically rigorous.
Temperature-dependent reaction rate modelling across multiple scenarios.
Humidity-adjusted degradation rate prediction.
Structure-based property estimation using validated models.
Prediction validation against published reference data.
Integrated degradation timeline generation.
Packaging performance comparison and shelf-life impact assessment.
Quantitative excipient interaction risk assessment.
Transparent prediction reliability scoring.
Regulatory compliance assessment against ICH guidelines.
Long-term stability projection across ICH climate zones.
Parameter impact ranking and risk identification.
Dose-dependent regulatory threshold mapping.
Input data reliability classification and scoring.
Multi-category cross-API interaction assessment for fixed-dose combination products.
Everything you need for predictive stability analysis — from single APIs to complex fixed-dose combinations.
PSPS predictions have been validated against published peer-reviewed stability data across multiple APIs.
| Validation Metric | Result | Acceptance Criteria | Status |
|---|---|---|---|
| Kinetic Parameters | Within published ranges | Literature reference values | Pass |
| Degradation Rate | Consistent with expectations | Expected range for API class | Consistent |
| Assay Prediction (6 months) | Matched published data | Multiple literature sources | Match |
| Impurity Prediction | Within reported range | Published impurity data | Validated |
| Overall Deviation | Minimal | ≤15% deviation threshold | Validated |
| Confidence Score | HIGH | Multiple high-quality data sources | HIGH |
Intelligent literature synthesis combined with rigorous computation engines. A unique approach no other tool offers.
The only stability prediction tool offering quantitative fixed-dose combination interaction assessment.
Every number in the final report traces directly to a validated computation engine — ensuring complete accuracy.
Clear confidence scoring tells you exactly how much to trust each prediction and why — no black boxes.
18-section ICH-aligned reports that can be directly included in regulatory submissions.
Smart caching means repeat predictions are instant. Adding one API to an existing FDC requires only one new analysis.
From bench scientists to regulatory affairs — PSPS accelerates decisions across the pharmaceutical development lifecycle.
Screen excipient/packaging combinations before committing to formal stability studies.
Design ICH stability protocols using predicted timepoints and acceptance criteria.
Generate predictive stability data for pre-submission risk assessments.
Compare multiple formulation candidates quantitatively.
Offer rapid stability screening as a value-added service.
Teach stability science with real-world kinetic modelling.
PSPS predictions are aligned with international pharmaceutical guidelines.
PSPS is grounded in peer-reviewed pharmaceutical science — delivering predictions you can trust and defend.
Kinetic ModellingPredicts degradation rates across storage conditions using established kinetic principles.
Degradation ProfilingGenerates timeline projections for product quality attributes over the shelf-life.
Moisture Impact AnalysisAccounts for moisture sensitivity across different storage and packaging conditions.
Packaging PerformanceEvaluates packaging barrier properties and their impact on long-term product stability.
Request a demo to see PSPS in action with your own formulations. Our team will walk you through the 4-phase pipeline and show you a real prediction.