API Stability
Drug labels often provide lots of important information and instructions, such as whether a drug can be placed in the sun, refrigerated, etc. This information relates to a series of stability testings during the drug manufacturing process. API stability is a crucial part of the drug development and approval process that determines the safety and integrity of the drug, as well as its shelf life and storage conditions. More and more pharmaceutical companies are now investing a lot of time and effort into the stability investigation. BOC Sciences conducts stability studies on APIs according to ICH guidelines to ensure that the final drug product meets cGMP standards. Our expert teams have the historical experience to complete your stability studies according to your desired program. We can utilize our knowledge to ensure success for your small-molecule API stability studies.
What is API Stability?
API Stability is widely used to assess how the quality of APIs changes with time under the influence of environmental factors, including temperature, humidity and light. The process determines if there are any physical, chemical or microbiological changes that affect the efficiency and integrity of the final product.
Figure 1. Decision tree for drug products. (Bujji, K, R. 2017)
Our Services
To make it easier and better for researchers, BOC Sciences provides API stability 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. We investigate the API stability during the development phase of a project to inform the ICH stability studies
- Influence factor studies at the conditions of high temperature, high humidity and light per China regulatory requirements
- Stability studies as per ICH Q1 and NMPA guidelines(40°C /75%RH, 30°C /65%RH, 25°C /60%RH, 5°C). For stable compounds, our expert teams perform an accelerated study at 40°C/75% RH, as well as long-term studies at 30°C/65% RH or 25°C/60% RH
- Generate stability protocols and reports applicable to IND/NDA filing
BOC Sciences stability protocols
- Qualified stability chambers for all ICH conditions, including photostability
- GLP studies with dose formulation analysis
- Statistical analysis and data trending
Stability Chamber (IQ/OQ/PQ, annual calibration): temperature, humidity, light
BOC Sciences can support a wider range of storage conditions as needed:
- Stress testing, accelerated, intermediate, long-term, etc
- Stability sample management
- Stability testing: chemical properties, physical properties
Stability Management
- Development of stability indicating HPLC method
- Drug substances and products
- Clinical supplies
- Protocol driven
- Customer defined report format
- Chamber IQ/OQ and calibrations
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 API stability at competitive prices for global customers. Personalized and customized services of API stability 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
- Bujji, K, R. Photo stability Testing on Pharmaceuticals. 2017.
