Pharmaceutical stability testing is essential for evaluating the chemical, physical, and microbiological changes that may occur over time under defined environmental conditions. Understanding degradation pathways and the factors influencing product stability is critical to establishing appropriate storage conditions, determining expiration dating, and maintaining pharmaceutical quality throughout a product’s shelf life.
PD Partners provides comprehensive stability testing and controlled storage services designed to meet applicable regulatory requirements and industry standards. Our programs combine controlled environmental storage, stability indicating analytical methods, and systematic data evaluation to monitor product degradation and identify potential stability concerns. Whether supporting an initial regulatory submission or fulfilling ongoing commercial stability commitments, we provide the scientific expertise and laboratory resources necessary to generate reliable, defensible stability data.
How It Works
PD Partners conducts long-term, intermediate, and accelerated stability studies in accordance with applicable ICH guidelines. Our controlled environmental storage capabilities include:
- 25°C / 60% RH — Long-term stability
- 30°C / 65% RH — Intermediate or long-term stability, as applicable
- 40°C / 75% RH — Accelerated stability
Stability samples are maintained under specified environmental conditions and evaluated at established intervals to identify chemical degradation, changes in impurity profiles, and other relevant quality attributes. Testing may include assay determination, degradation product analysis, physical characteristics, and microbiological evaluations, as appropriate.
Our analytical expertise allows us to evaluate degradation trends, identify potential stability concerns, and provide data supporting scientifically justified shelf life assignments and regulatory documentation.
Our Stability Testing Process
1. Stability Program Assessment
Evaluate product characteristics, packaging configurations, regulatory requirements, and study objectives to establish an appropriate stability strategy.
2. Protocol Development
Establish stability protocols defining storage conditions, sampling intervals, analytical procedures, product specifications, and reporting requirements.
3. Controlled Sample Storage
Maintain stability samples under specified environmental conditions with appropriate temperature and humidity monitoring.
4. Scheduled Sample Testing
Evaluate samples at designated intervals using stability indicating analytical methods to monitor degradation and relevant product quality attributes.
5. Data Evaluation & Trending
Assess analytical results and degradation trends to identify potential stability concerns and evaluate compliance with established specifications.
6. Stability Reporting & Documentation
Prepare stability reports and supporting documentation for regulatory submissions, shelf life evaluations, and commercial stability commitments.
Benefits of Working with PD Partners
- Comprehensive long-term, intermediate, and accelerated ICH stability programs
- Controlled environmental storage under established laboratory procedures
- Scientific assessment of stability trends and potential degradation pathways
- Reliable data supporting expiration dating and regulatory requirements
- Stability programs supporting both development and commercial pharmaceutical products
Our Commitment to Quality
PD Partners conducts stability studies within an established cGMP quality system, emphasizing controlled storage conditions, reliable analytical methods, accurate documentation, and data integrity.
We recognize the importance of scientifically sound stability data in supporting regulatory decisions and maintaining pharmaceutical product quality. Our approach focuses on consistent study execution, careful evaluation of analytical results, and clear documentation to help clients meet their stability testing and regulatory obligations.