PSPS — Pharmaceutical Stability Prediction System

Formulation Input Required

API Information

API Name *

API name is required

Dose (mg) *

Valid dose required

Dosage Form *

Dosage form required

SMILES (optional — improves accuracy)

Manufacturing Method (opt.)

Regulatory Market (opt.)

Composition Table

Ingredient	mg	% w/w	Function
Total	—	—

Total must be 98.5–101.5% w/w

Stability Test Conditions

Temperature (°C) *

Temperature required

Humidity (%RH) *

Humidity required

Duration (months) *

Duration required

ICH Climatic Zone *

ICH zone required

Packaging Type *

Packaging type required

Container Closure *

Container closure required

Specifications (ICH defaults if left blank)

Leave blank to apply ICH Q3B(R2) defaults: Assay 95–105%, Total Impurities ≤2.0%, Specified ≤0.5%, Unspecified ≤0.10%

Assay Lower (%)

Assay Upper (%)

Total Impurities (%)

Specified Impurity (%)

Moisture Spec (%)

Only for solid dosage forms

Target Shelf Life (mo)

Additional Context (optional)

Known Degradation Products (comma-separated)

Previous Stability Data (brief summary)

Specific Concerns

~3–5 minutes · 8–22 web searches · 13 computation engines · Full ICH report

Stability Prediction Report Ready

Stability Report Appears Here

Fill in the formulation details on the left, then click Run Stability Prediction to generate a full ICH-aligned stability report with kinetic modelling and literature validation.

Enter API name, dose, and dosage form

Build composition table with all excipients (total = 100%)

Set test conditions (temperature, humidity, duration, packaging)

Click Run — literature search + computation runs automatically

Running Analysis…

Literature Research

Queued

Computation (13 Engines)

Queued

Validation & Cross-Check

Queued

Report Generation

Queued