ICH-Compliant Stability Testing Across
All Climatic Zones
Our Stability Studies services deliver structured, regulatory-aligned stability testing for pharmaceutical products across all climatic zones
and dosage forms. We operate state-of-the-art stability chambers with real-time monitoring to generate reliable
stability data that informs shelf-life assignment, formulation decisions, and regulatory submissions.
All activities are performed under controlled quality systems to ensure data integrity, traceability, and
compliance with current regulatory expectations.
Stability Infrastructure & Environmental Control
Our stability studies are supported by dedicated infrastructure designed to maintain precise environmental conditions throughout the study duration.
Stability chambers are qualified, calibrated, and continuously monitored to ensure temperature and humidity remain within defined limits.
Infrastructure capabilities include:
- Qualified stability chambers for long-term, intermediate, and accelerated studies
- Continuous environmental monitoring with alarm systems
- Secure sample storage, tracking, and traceability
- Validated data capture systems supporting data integrity
Ensures reliable environmental control and audit-ready stability operations.
Scope of Stability Services
We provide comprehensive stability testing services across a wide range of dosage forms and development stages, aligned with applicable regulatory guidelines.
Stability study designs are tailored based on product characteristics, packaging configurations, and intended market requirements.
Our stability service scope includes:
- Long-term, intermediate, and accelerated stability studies
- Stability testing for Developmental batches, DEC studies and Pilot bio batches
- Photostability and in-use stability studies
- Packaging compatibility and container-closure evaluation
Supports informed shelf-life assignment and lifecycle stability management.
Stability Testing Across Climatic Zones
Stability studies are conducted in accordance with ICH guidelines across multiple climatic zones to support global regulatory submissions.
Study conditions are selected based on product characteristics and intended market distribution.
Stability programs support:
- Long-term stability testing under zone-specific conditions
- Intermediate studies for trend evaluation
- Accelerated studies to assess product robustness
- Data trending and reporting to support shelf-life justification
Enables region-specific stability assessment and regulatory readiness.
ICH-Compliant Stability Conditions Across Climatic Zones
| Study Type | Zone I (Temperate) | Zone II (Subtropical) | Zone III (Hot & Dry) | Zone IVa (Hot & Humid) | Zone IVb (Hot & Very Humid) |
|---|---|---|---|---|---|
| Long-Term | 25°C ± 2°C 60% RH ± 5% | 30°C ± 2°C 60% RH ± 5% | 30°C ± 2°C 35% RH ± 5% | 30°C ± 2°C 65% RH ± 5% | 30°C ± 2°C 75% RH ± 5% |
| Intermediate | 30°C ± 2°C 65% RH ± 5% | 30°C ± 2°C 65% RH ± 5% | 30°C ± 2°C 65% RH ± 5% | 30°C ± 2°C 75% RH ± 5% | 30°C ± 2°C 75% RH ± 5% |
| Accelerated | 40°C ± 2°C 75% RH ± 5% | 40°C ± 2°C 75% RH ± 5% | 40°C ± 2°C 75% RH ± 5% | 40°C ± 2°C 75% RH ± 5% | 40°C ± 2°C 75% RH ± 5% |
Our Stability Approach
Scientific, Transparent & Quality-Driven
Our stability services are structured to support confident development decisions and regulatory readiness:
- Study design aligned with ICH and regional regulatory expectations
- Controlled execution with real-time environmental logging
- Comprehensive documentation suitable for submission packages
- Data integrity and audit readiness through validated systems
This approach ensures stability data is reliable, interpretable, and supportive of product development and lifecycle management.
Why Stability Studies Matter
Stability testing is foundational to pharmaceutical product development and lifecycle support. It provides evidence of how a product performs over time under defined conditions, informing:
- Shelf-life and storage condition assignments
- Formulation optimization decisions
- Packaging compatibility choices
- Regulatory documentation and submissions
Structured stability data promotes risk-aware decision-making throughout development and supports product quality assurance.
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Let’s discuss how our pharmaceutical capabilities can support your requirements.