Stability Studies
Protect the integrity and shelf-life of your products
QbD Group ensures your products meet the highest quality standards through rigorous ICH-compliant stability studies with state-of-the-art facilities.
What are stability studies?
Stability studies are scientific investigations to determine how the quality of a product varies with time under environmental factors such as temperature, humidity, light, and pH. These studies assess the product's physical, chemical, microbiological, and functional properties over its lifecycle.
Key aspects include:
- ICH stability testing: Long-term, intermediate, and accelerated studies.
- Stress testing: Examining product responses to extreme conditions.
- In-use stability testing: Evaluating stability during typical usage conditions.
- Temperature cycle tests: Freeze-thaw and transportation simulations.
- Validation of stability-indicating methods: Tracking product degradation accurately.
Why are stability studies essential?
Regulatory compliance
Ensures your product meets the strict requirements of health authorities.
Shelf-life determination
Helps establish appropriate storage conditions and expiry dates.
Product quality assurance
Confirms that your product remains stable under specified conditions.
Risk mitigation
Identifies potential stability issues during development.
Market confidence
Assure customers and stakeholders of your product's quality.
Support for global markets
Enables compliance with international guidelines like ICH.
Cost efficiency
Identify potential issues early to avoid costly recalls or rework.
Data-driven decision making
Optimize formulation, packaging, and storage conditions based on stability data.
How can we help?
We offer a complete suite of stability study services tailored to your needs. Our ICH-compliant stability storage facilities are equipped with advanced technology for 24/7 monitoring, access control, and alarm systems to ensure the integrity of your samples.
ICH stability testing
Conduct long-term, intermediate, and accelerated testing following ICH guidelines.
Stress testing
Assess stability under challenging conditions, including light, pH, humidity, and oxidation.
In-use stability testing
Evaluate stability during typical use scenarios.
Temperature cycle tests
Simulate freeze-thaw cycles and transportation stress.
Stability-indicating method development & validation
Ensure accurate tracking of product degradation.
Comprehensive study management
From protocol development to reporting, we provide end-to-end support.
Our process
A structured approach to stability testing that ensures compliance and reliability.
1. Study design
Defining protocols based on ICH guidelines and product requirements.
2. Sample storage
Placing samples in ICH-compliant stability chambers with 24/7 monitoring.
3. Testing
Conducting scheduled analyses at defined time points.
4. Reporting
Delivering comprehensive stability reports for regulatory submissions.
Why QbD Group
Your trusted partner
With QbD Group, you gain:
Deep expertise
decades of experience in stability testing across various industries.
State-of-the-art facilities
fully secured, ICH-compliant stability storage.
Tailored solutions
customized testing strategies aligned with your product's requirements.
Regulatory support
in-depth understanding of global regulatory standards.
End-to-end services
from study design to execution, we manage every step.
Let's talk Lab Services
From method validation to stability testing, our lab experts are ready to support your analytical needs.