Stability Study
Stability study is essential to deliver a high-quality pharmaceutical product. Stability study determines how a drug product will react when exposed to conditions such as heat, pH, humidity and radiation. Understanding how a drug product changes over time is critical to patient safety and is needed to guide the storage and disposal of the product. BOC Sciences is committed to providing comprehensive and cost-effective GMP stability testing, study management and stability storage services in accordance with cGMP and ICH guidelines
Figure 1. Summary of characteristics of stability studies. (Huynh-Ba, K.; Dong, M. W. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides stability study service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
How is stability testing performed?
- Data collection: to determine the most appropriate method for product stability and the stability of its packaging
- Forced degradation studies: to determine the stability of a product over time
- Stress testing: to identify possible degradation products, which in turn helps establish the intrinsic stability of degradation pathways and molecules, and verifies the stability indicating capability of the analytical procedures used
- Studies are performed under at least two different storage conditions: long-term ambient storage and accelerated conditions. Each stability program is conducted according to an approved protocol, and testing includes the physical and chemical properties of the product that may change during storage, potentially affecting its strength, quality, purity, and ultimately, safety
Figure 2. Storage conditions established by the ICH. (Huynh-Ba, K.; Dong, M. W. 2020)
How much of the products should be tested?
Typically, three validation batches of a product are placed under formal stability studies, and we recommend to perform informal studies of development batches prior to initiating formal studies, which is helpful in designing a better packaging configurations. In addition, batches produced for additional validation, such as process scale-ups, are often added to stability studies to demonstrate ongoing material stability
Full range of stability study services
- Protocol design
- Analytical method transfer
- Study management
- Sample analysis
- QA approved reporting
- Transport simulation and in-use stability programs
- From early stage materials to validation and commercial batches, all conditions are continuously monitored with backup systems to ensure a safe and controlled environment
- Reference standard management is provided to ensure no avoidable delays
Figure 3. An example of stress conditions for APIs. (Huynh-Ba, K.; Dong, M. W. 2020)
ICH-compliant facilities
BOC Sciences is equipped with state-of-the-art, walk-in stability chambers that can provide ICH-compliant, climatic storage facilities to satisfy all requirements
- -80 °C and -20 °C freezers
- 5 °C freezer
- 25 °C/60% RH long-term stability storage
- 30 °C/65% RH intermediate stability storage
- 30 °C/75% RH climate Zone IV
- 40 °C/75% RH accelerated stability storage
- Photo-stability
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of stability study at competitive prices for global customers. Personalized and customized services of stability study can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Huynh-Ba, K.; Dong, M. W. Stability Studies and Testing of Pharmaceuticals: An Overview. Lc Gc North America. 2020. 38(6): 325.
