What We Do · Stability Studies
Stability Studies
What We Do · Stability Studies
Stability Studies
Enventor's ICH-compliant stability program generates the data needed to determine shelf life, support regulatory submissions and monitor commercial product quality across all dosage forms.
Our stability facilities and analytical lab work hand-in-hand to deliver timely, reliable, stability-indicating data — closely integrated with formulation and analytical development.
Core Capabilities
Integrated services delivered with scientific rigor
01
Stability Study Types
- Accelerated stability studies
- Intermediate stability studies
- Long-term stability studies
- Photostability and stress / forced degradation studies
02
Protocol & Execution
- Stability protocol preparation per ICH Q1A(R2)
- Sample pull schedule design and execution
- Stability-indicating analytical methods
- Container-closure compatibility studies
03
Monitoring & Reporting
- Ongoing stability monitoring
- Trend analysis and OOS / OOT investigation
- Shelf life and re-test period determination
- Stability summary reports for submissions
04
Coverage & Equipment
- Clinical, exhibit and commercial batches
- ICH-compliant stability chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH)
- Photostability (ICH Q1B) options
- Stability for OSD, semi-solids, liquids, injectables
Typical Timeline
How a typical engagement unfolds
01
Protocol preparation
1–2 weeks
02
Sample charging
1 week
03
Accelerated (40°C/75% RH)
3 / 6 months
04
Intermediate (30°C/65% RH)
6 / 12 months
05
Long-term (25°C/60% RH)
12–36 months
06
Stability summary report
2–3 weeks
Pull points follow ICH Q1A(R2). Shelf life is established from long-term data, supported by accelerated and intermediate conditions.
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From early development through commercialization — backed by science, quality, and regulatory expertise.
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